Stage IIIA Distal Bile Duct Cancer AJCC v8, Stage IIIA Gallbladder Cancer AJCC v8, Stage IIIA Intrahepatic Cholangiocarcinoma AJCC v8, Stage IIIB Distal Bile Duct Cancer AJCC v8, Stage IIIB Gallbladder Cancer AJCC v8, Stage IIIB Intrahepatic Cholangiocarcinoma AJCC v8, Stage III Distal Bile Duct Cancer AJCC v8, Stage III Gallbladder Cancer AJCC v8, Stage III Intrahepatic Cholangiocarcinoma AJCC v8, Stage IVA Gallbladder Cancer AJCC v8, Stage IVB Gallbladder Cancer AJCC v8, Stage IV Distal Bile Duct Cancer AJCC v8, Stage IV Gallbladder Cancer AJCC v8, Stage IV Intrahepatic Cholangiocarcinoma AJCC v8, Unresectable Extrahepatic Bile Duct Carcinoma, Unresectable Gallbladder Carcinoma, Unresectable Intrahepatic Cholangiocarcinoma
Conditions
Brief summary
This phase III trial studies how well gemcitabine hydrochloride and cisplatin given with or without nab-paclitaxel work in treating patients with newly diagnosed biliary tract cancers that have spread to other places in the body. Drugs used in chemotherapy, such as gemcitabine hydrochloride, cisplatin, and nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not known if giving gemcitabine hydrochloride and cisplatin with or without nab-paclitaxel may work better at treating biliary tract cancers.
Detailed description
PRIMARY OBJECTIVES: I. To compare overall survival (OS) in patients with untreated, advanced biliary cancers treated with gemcitabine hydrochloride (gemcitabine) and cisplatin (GC) versus those treated with gemcitabine, cisplatin, and nab-Paclitaxel (GCN). SECONDARY OBJECTIVES: I. To compare progression-free survival (PFS) in patients treated with GC versus GCN. II. To compare overall response rate (ORR), complete and partial, confirmed and unconfirmed, in the subset of patients with measurable disease treated with GC versus GCN. III. To compare disease control rate (confirmed and unconfirmed; complete response + partial response + stable disease) (DCR) in patients treated with GC versus GCN. IV. To evaluate the frequency and severity of toxicity associated with GC and GCN in the patient population. V. To explore the correlation between change in cancer antigen 19-9 (CA19-9) levels from baseline to post-treatment (after 3 cycles) and overall response rate, in each treatment arm separately and in the total cohort. ADDITIONAL OBJECTIVES: I. To bank tissue and blood for future translational medicine studies. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive nab-paclitaxel intravenously (IV) over 30 minutes, cisplatin IV over 60 minutes, and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive cisplatin IV over 60 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months for 2 years and then at the end of year 3.
Interventions
DRUGCisplatin
Given IV
DRUGGemcitabine Hydrochloride
Given IV
DRUGNab-paclitaxel
Given IV
Sponsors
National Cancer Institute (NCI)
SWOG Cancer Research Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must have histologically or cytologically confirmed intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, or gallbladder cancer * NOTE: Pathology report must be uploaded in Rave. Histology report must be consistent with an adenocarcinoma with pancreaticobiliary primary assuming there are no pancreatic lesions and other primaries are ruled out per local standard * Patients must have documented metastatic or locally advanced unresectable disease on computed tomography (CT) or magnetic resonance (MR) imaging CT scans or MRIs used to assess measurable disease. Must have been completed within 28 days prior to registration. CT scans or MRIs used to assess non-measurable disease must have been completed within 42 days prior to registration. All disease must be assessed and documented on the Baseline Tumor Assessment Form * Patient must not have a current diagnosis of ampullary cancer * Patients must not have received prior systemic therapy for the current metastatic or locally advanced biliary cancer * Patient must not have received adjuvant therapy within 6 months prior to registration * Patients must have a complete medical history and physical exam within 28 days prior to registration * Patients must have a Zubrod performance status of 0 or 1 * Patients must not have a history of peripheral neuropathy of grade 2 or greater by Common Terminology Criteria for Adverse Events (CTCAE) 5.0. In CTCAE version 5.0 grade 2 sensory neuropathy is defined as ?moderate symptoms; limiting instrumental activities of daily living (ADLs)? * Absolute neutrophil count (ANC) \>= 1,500/mcL (obtained within 28 days prior to registration) * Platelets \>= 100,000/mcL (obtained within 28 days prior to registration) * Hemoglobin \>= 8 g/dL (obtained within 28 days prior to registration) * Serum albumin \>= 2.8 g/dL (obtained within 28 days prior to registration) * Total bilirubin =\< 1.5 x institutional upper limit of normal (IULN) (except patients with Gilbert?s syndrome, who must have a direct bilirubin \< 1.5 mg/dL) (obtained within 28 days prior to registration) * Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 8 x IULN (obtained within 28 days prior to registration) * Serum creatinine =\< IULN OR calculated creatinine clearance \>= 60 mL/min (obtained within 28 days prior to registration) * Patients must have CA19-9 obtained within 42 days prior to registration * Patients must have sodium, potassium, bicarbonate, chloride, blood urea nitrogen (BUN), calcium, total protein, magnesium, and alkaline phosphatase obtained within 28 days prior to registration * Patients must not have an active infection requiring systemic therapy * No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for two years * Patients must not be pregnant or nursing. Women/men of reproductive potential must have agreed to use an effective contraceptive method. A woman is considered to be of reproductive potential if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, effective contraception also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures * Sites must seek additional patient consent for the future use of specimens * Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines * As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Up to 3 years | OS will be determined using the log-rank test with stratification by disease site (gallbladder adenocarcinoma versus \[vs.\] intrahepatic cholangiocarcinoma vs. extrahepatic cholangiocarcinoma), disease stage (locally advanced vs. metastatic), and Zubrod performance status (0 vs. 1). Distributions of overall survival by treatment arm will be estimated using the method of Kaplan-Meier. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Duration of treatment and follow-up until death or 3 years post registration. | Only adverse events that are possibly, probably, or definitely related to study drugs are reported. CTCAE Version 5.0 was used for all AE reporting. |
| Progression-free Survival (PFS) | From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 3 years | Distributions of PFS will be described using cumulative incidence estimates with differences in these estimates between treatment arms assessed by a stratified Cox regression model. |
| Overall Response Rate (ORR) as Measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Criteria | Up to 3 years | ORR is defined as confirmed and unconfirmed; complete response + partial response + stable disease. The chi-square test will be used to compare ORR, disease control rate (DCR), and rates of toxicity events across arms. ORR will be assessed in the subset of patients with measurable disease. |
| Disease Control Rate as Measured by RECIST 1.1 Criteria | Up to 3 years | The chi-square test will be used to compare ORR, DCR, and rates of toxicity events across arms. Disease control includes confirmed and unconfirmed complete response, confirmed and unconfirmed partial response, and stable disease. In patients with non-measurable disease, disease control will be defined as those who are alive without disease progression. |
| Changes in Carbohydrate Antigen 19-9 (CA 19-9) Levels | Baseline up to course 3 | Correlations between changes in CA19-9 levels from baseline to post-treatment and ORR will be estimated via logistic regression models, both within each treatment arm and in the overall cohort. Analyses will explore the prognostic and predictive values of CA19-9 for disease response. |
Countries
United States
Participant flow
Pre-assignment details
452 participants were registered to the study, 10 were ineligible and 1 was not analyzable.
Participants by arm
| Arm | Count |
|---|---|
| Gem+Cisplatin+Nab-paclitaxel Patients receive nab-paclitaxel IV over 30 minutes, cisplatin IV over 60 minutes, and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. | 294 |
| Gemcitabine + Cisplatin Patients receive cisplatin IV over 60 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. | 147 |
| Total | 441 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event or side effects | 72 | 28 |
| Overall Study | Death | 9 | 6 |
| Overall Study | Other - not protocol specified | 45 | 18 |
| Overall Study | Progression/relapse | 132 | 60 |
| Overall Study | Reason under review | 3 | 2 |
| Overall Study | Refusal unrelated to adverse event | 33 | 33 |
Baseline characteristics
| Characteristic | Gemcitabine + Cisplatin | Gem+Cisplatin+Nab-paclitaxel | Total |
|---|---|---|---|
| Age, Continuous | 63.9 years | 63.2 years | 63.5 years |
| Disease Site Extrahepatic cholangiocarcinoma | 24 Participants | 50 Participants | 74 Participants |
| Disease Site Gallbladder adenocarcinoma | 24 Participants | 46 Participants | 70 Participants |
| Disease Site Intrahepatic cholangiocarcinoma | 99 Participants | 198 Participants | 297 Participants |
| Disease Stage Locally advances | 41 Participants | 77 Participants | 118 Participants |
| Disease Stage Metastatic | 106 Participants | 217 Participants | 323 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants | 30 Participants | 45 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 125 Participants | 256 Participants | 381 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 7 Participants | 8 Participants | 15 Participants |
| Performance Status 0 | 75 Participants | 147 Participants | 222 Participants |
| Performance Status 1 | 72 Participants | 147 Participants | 219 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 14 Participants | 21 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 18 Participants | 25 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 12 Participants | 15 Participants | 27 Participants |
| Race (NIH/OMB) White | 119 Participants | 244 Participants | 363 Participants |
| Sex: Female, Male Female | 81 Participants | 162 Participants | 243 Participants |
| Sex: Female, Male Male | 66 Participants | 132 Participants | 198 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 237 / 294 | 115 / 147 |
| other Total, other adverse events | 280 / 287 | 133 / 134 |
| serious Total, serious adverse events | 27 / 287 | 11 / 134 |
Outcome results
Primary
Overall Survival (OS)
OS will be determined using the log-rank test with stratification by disease site (gallbladder adenocarcinoma versus \[vs.\] intrahepatic cholangiocarcinoma vs. extrahepatic cholangiocarcinoma), disease stage (locally advanced vs. metastatic), and Zubrod performance status (0 vs. 1). Distributions of overall survival by treatment arm will be estimated using the method of Kaplan-Meier.
Time frame: Up to 3 years
Population: This population includes the 441 eligible and evaluable participants. 294 in the Gem+Cisplatin+Nab-paclitaxel arm and 147 in the Gemcitabine + Cisplatin arm.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gem+Cisplatin+Nab-paclitaxel | Overall Survival (OS) | 14.0 months |
| Gemcitabine + Cisplatin | Overall Survival (OS) | 13.6 months |
p-value: 0.4195% CI: [0.72, 1.14]Log Rank
Secondary
Changes in Carbohydrate Antigen 19-9 (CA 19-9) Levels
Correlations between changes in CA19-9 levels from baseline to post-treatment and ORR will be estimated via logistic regression models, both within each treatment arm and in the overall cohort. Analyses will explore the prognostic and predictive values of CA19-9 for disease response.
Time frame: Baseline up to course 3
Population: one participant had missing baseline CA and 96 participants had missing post-treatment CA. They were not included in the analysis
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gem+Cisplatin+Nab-paclitaxel | Changes in Carbohydrate Antigen 19-9 (CA 19-9) Levels | -12 U/mL |
| Gemcitabine + Cisplatin | Changes in Carbohydrate Antigen 19-9 (CA 19-9) Levels | -2.97 U/mL |
Secondary
Disease Control Rate as Measured by RECIST 1.1 Criteria
The chi-square test will be used to compare ORR, DCR, and rates of toxicity events across arms. Disease control includes confirmed and unconfirmed complete response, confirmed and unconfirmed partial response, and stable disease. In patients with non-measurable disease, disease control will be defined as those who are alive without disease progression.
Time frame: Up to 3 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gem+Cisplatin+Nab-paclitaxel | Disease Control Rate as Measured by RECIST 1.1 Criteria | 78 percentage of participants |
| Gemcitabine + Cisplatin | Disease Control Rate as Measured by RECIST 1.1 Criteria | 67 percentage of participants |
Secondary
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs.
Only adverse events that are possibly, probably, or definitely related to study drugs are reported. CTCAE Version 5.0 was used for all AE reporting.
Time frame: Duration of treatment and follow-up until death or 3 years post registration.
Population: Participants who were eligible and received at least one dose of protocol treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Diarrhea | 13 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Acute kidney injury | 5 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Alanine aminotransferase increased | 6 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Alkaline phosphatase increased | 3 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Anemia | 95 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Anorexia | 8 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Arthralgia | 1 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Ascites | 2 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Aspartate aminotransferase increased | 5 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Ataxia | 1 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Atrial fibrillation | 1 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Back pain | 1 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Blood and lymphatic system disorders - Other, spec | 1 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Blood bilirubin increased | 3 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Cardiac arrest | 1 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Catheter related infection | 0 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Cholecystitis | 1 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Chronic kidney disease | 2 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Colitis | 2 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Constipation | 1 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Creatinine increased | 1 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Death NOS | 1 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Dehydration | 4 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Delirium | 1 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Abdominal pain | 2 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Dizziness | 1 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Dysphagia | 1 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Dyspnea | 0 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Edema limbs | 4 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Endocarditis infective | 0 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Enterocolitis | 1 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Enterocolitis infectious | 3 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Epistaxis | 2 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Esophagitis | 1 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Fatigue | 27 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Febrile neutropenia | 10 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Fever | 1 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Flu like symptoms | 2 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | GGT increased | 2 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Gallbladder infection | 0 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Gastric hemorrhage | 1 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Gastrointestinal disorders - Other, specify | 1 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | General disorders and administration site conditio | 1 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Generalized muscle weakness | 3 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Headache | 1 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Hearing impaired | 1 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Heart failure | 0 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Hematuria | 1 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Hepatic infection | 1 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Hepatobiliary disorders - Other, specify | 2 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Hyperglycemia | 0 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Hyperkalemia | 2 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Hypertension | 7 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Hypoalbuminemia | 5 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Hypocalcemia | 3 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Hypokalemia | 9 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Hypomagnesemia | 6 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Hyponatremia | 6 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Hypotension | 3 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Infections and infestations - Other, specify | 3 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Infusion related reaction | 0 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Investigations - Other, specify | 1 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Lung infection | 2 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Lymphocyte count decreased | 30 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Memory impairment | 1 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Mucositis oral | 2 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Multi-organ failure | 1 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Muscle weakness lower limb | 1 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Myalgia | 1 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Nausea | 11 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Neutrophil count decreased | 105 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Pain | 1 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Paresthesia | 1 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Peripheral motor neuropathy | 1 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Peripheral sensory neuropathy | 10 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Peritoneal infection | 0 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Platelet count decreased | 56 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Pleural effusion | 1 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Portal vein thrombosis | 0 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Rectal hemorrhage | 1 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Respiratory failure | 1 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Respiratory, thoracic and mediastinal disorders - | 1 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Seizure | 0 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Sepsis | 15 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Skin infection | 4 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Superior vena cava syndrome | 1 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Supraventricular tachycardia | 1 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Syncope | 2 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Thromboembolic event | 9 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Thrush | 1 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Typhlitis | 1 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Upper gastrointestinal hemorrhage | 2 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Urinary tract infection | 4 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Vascular access complication | 1 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Vasovagal reaction | 1 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Vomiting | 5 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Wheezing | 0 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | White blood cell decreased | 46 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Peripheral motor neuropathy | 0 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Abdominal pain | 0 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Hepatobiliary disorders - Other, specify | 0 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Acute kidney injury | 3 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Wheezing | 1 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Alanine aminotransferase increased | 1 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Hyperglycemia | 1 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Alkaline phosphatase increased | 1 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Peripheral sensory neuropathy | 1 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Anemia | 30 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Hyperkalemia | 0 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Anorexia | 0 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Supraventricular tachycardia | 0 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Arthralgia | 0 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Hypertension | 1 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Ascites | 0 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Peritoneal infection | 1 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Aspartate aminotransferase increased | 0 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Hypoalbuminemia | 1 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Ataxia | 0 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Urinary tract infection | 1 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Atrial fibrillation | 0 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Hypocalcemia | 1 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Back pain | 0 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Platelet count decreased | 20 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Blood and lymphatic system disorders - Other, spec | 1 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Hypokalemia | 2 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Blood bilirubin increased | 1 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Syncope | 1 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Cardiac arrest | 0 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Hypomagnesemia | 5 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Catheter related infection | 1 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Pleural effusion | 0 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Cholecystitis | 0 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Hyponatremia | 4 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Chronic kidney disease | 1 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Vomiting | 0 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Colitis | 0 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Hypotension | 1 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Constipation | 0 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Portal vein thrombosis | 1 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Creatinine increased | 0 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Infections and infestations - Other, specify | 2 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Death NOS | 1 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Thromboembolic event | 1 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Dehydration | 2 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Infusion related reaction | 1 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Delirium | 0 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Rectal hemorrhage | 0 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Diarrhea | 1 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Investigations - Other, specify | 0 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Dizziness | 0 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Vascular access complication | 0 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Dysphagia | 0 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Lung infection | 0 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Dyspnea | 2 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Respiratory failure | 0 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Edema limbs | 0 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Lymphocyte count decreased | 4 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Endocarditis infective | 1 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Thrush | 0 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Enterocolitis | 0 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Memory impairment | 0 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Enterocolitis infectious | 0 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Respiratory, thoracic and mediastinal disorders - | 0 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Epistaxis | 0 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Mucositis oral | 0 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Esophagitis | 0 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | White blood cell decreased | 10 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Fatigue | 8 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Multi-organ failure | 0 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Febrile neutropenia | 2 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Seizure | 1 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Fever | 0 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Muscle weakness lower limb | 0 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Flu like symptoms | 0 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Typhlitis | 0 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | GGT increased | 0 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Myalgia | 0 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Gallbladder infection | 1 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Sepsis | 3 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Gastric hemorrhage | 0 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Nausea | 1 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Gastrointestinal disorders - Other, specify | 0 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Vasovagal reaction | 0 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | General disorders and administration site conditio | 0 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Neutrophil count decreased | 37 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Generalized muscle weakness | 1 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Skin infection | 1 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Headache | 0 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Pain | 0 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Hearing impaired | 0 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Upper gastrointestinal hemorrhage | 0 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Heart failure | 1 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Paresthesia | 0 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Hematuria | 0 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Superior vena cava syndrome | 0 Participants |
| Gemcitabine + Cisplatin | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. | Hepatic infection | 1 Participants |
Secondary
Overall Response Rate (ORR) as Measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Criteria
ORR is defined as confirmed and unconfirmed; complete response + partial response + stable disease. The chi-square test will be used to compare ORR, disease control rate (DCR), and rates of toxicity events across arms. ORR will be assessed in the subset of patients with measurable disease.
Time frame: Up to 3 years
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gem+Cisplatin+Nab-paclitaxel | Overall Response Rate (ORR) as Measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Criteria | Unconfirmed Partial Response | 30 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Overall Response Rate (ORR) as Measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Criteria | Increasing Disease | 38 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Overall Response Rate (ORR) as Measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Criteria | Partial Response | 55 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Overall Response Rate (ORR) as Measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Criteria | Symptomatic Deterioration | 2 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Overall Response Rate (ORR) as Measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Criteria | Stable/No Response | 134 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Overall Response Rate (ORR) as Measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Criteria | Assessment Inadaquate | 25 Participants |
| Gem+Cisplatin+Nab-paclitaxel | Overall Response Rate (ORR) as Measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Criteria | Complete Response | 6 Participants |
| Gemcitabine + Cisplatin | Overall Response Rate (ORR) as Measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Criteria | Assessment Inadaquate | 23 Participants |
| Gemcitabine + Cisplatin | Overall Response Rate (ORR) as Measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Criteria | Complete Response | 1 Participants |
| Gemcitabine + Cisplatin | Overall Response Rate (ORR) as Measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Criteria | Partial Response | 11 Participants |
| Gemcitabine + Cisplatin | Overall Response Rate (ORR) as Measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Criteria | Unconfirmed Partial Response | 19 Participants |
| Gemcitabine + Cisplatin | Overall Response Rate (ORR) as Measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Criteria | Stable/No Response | 67 Participants |
| Gemcitabine + Cisplatin | Overall Response Rate (ORR) as Measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Criteria | Increasing Disease | 22 Participants |
| Gemcitabine + Cisplatin | Overall Response Rate (ORR) as Measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Criteria | Symptomatic Deterioration | 3 Participants |
Secondary
Progression-free Survival (PFS)
Distributions of PFS will be described using cumulative incidence estimates with differences in these estimates between treatment arms assessed by a stratified Cox regression model.
Time frame: From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 3 years
Population: This population includes the 441 eligible and evaluable participants. 294 in the Gem+Cisplatin+Nab-paclitaxel arm and 147 in the Gemcitabine + Cisplatin arm.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gem+Cisplatin+Nab-paclitaxel | Progression-free Survival (PFS) | 7.5 months |
| Gemcitabine + Cisplatin | Progression-free Survival (PFS) | 6.3 months |