Metastatic Ureter Carcinoma, Metastatic Urethral Carcinoma, Stage III Bladder Urothelial Carcinoma AJCC v6 and v7, Stage III Ureter Cancer AJCC v7, Stage III Urethral Cancer AJCC v7, Stage IV Bladder Urothelial Carcinoma AJCC v7, Stage IV Ureter Cancer AJCC v7, Stage IV Urethral Cancer AJCC v7, Ureter Urothelial Carcinoma, Urethral Urothelial Carcinoma
Conditions
Brief summary
This phase II trial studies how well gemcitabine hydrochloride and eribulin mesylate work in treating patients with bladder cancer that has spread to other places in the body or cannot be removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride and eribulin mesylate, 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.
Detailed description
PRIMARY OBJECTIVES: I. To estimate the objective response rate of gemcitabine (gemcitabine hydrochloride)-eribulin (eribulin mesylate) (GE) when given to cisplatin ineligible patients with advanced or unresectable urothelial carcinoma who have not received any prior chemotherapy for the advanced disease. SECONDARY OBJECTIVES: I. To estimate the median progression-free survival (PFS). II. To summarize the toxicity profile (using Common Terminology Criteria for Adverse Events \[CTCAE\] version \[v\] 4 criteria) of the GE regimen in these patients. OUTLINE: Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1 and 8 and eribulin mesylate IV over 2-5 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 3 months for up to 36 months.
Interventions
DRUGEribulin Mesylate
Given IV
DRUGGemcitabine Hydrochloride
Given IV
Sponsors
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must have locally advanced or metastatic predominantly urothelial carcinoma of the bladder, ureter, or urethra that is not amenable to curative surgical treatment * Patients must have histologically confirmed predominantly urothelial carcinoma of the bladder, ureter, or urethra * Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) criteria, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as \>= 20 mm with conventional techniques or as \>= 10 mm with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam * Patients must be ineligible for treatment with cisplatin, based on one of: * Calculated creatinine clearance (CrCl) \>= 30 and \< 60 mL/min (Cockcroft-Gault) * CTCAE grade (Gr) \>= 2 hearing loss * CTCAE Gr \>= 2 neuropathy * Patients must not have received prior systemic therapy for their advanced cancer; prior intravesical therapy completed 4 weeks prior to enrollment and adjuvant/neoadjuvant chemotherapy completed more than 6 months prior to diagnosis of advanced disease are permitted * Zubrod performance status =\< 2 (Karnofsky \>= 60%) * Life expectancy of greater than 3 months * Leukocytes \>= 3,000/mcL * Absolute neutrophil count \>= 1,500/mcL * Platelets \>= 100,000/mcL * Total bilirubin \< 1.5 times the upper limit of normal (x ULN) for the institution * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 3 x institutional upper limit of normal * Creatinine clearance; calculated creatinine clearance (CrCl) \>= 30 mL/min and \< 60 mL/min (Cockroft-Gault) unless the patient qualified based on hearing loss or neuropathy * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of gemcitabine and eribulin administration * Ability to understand and the willingness to sign a written informed consent document
Exclusion criteria
* Patients with a small cell component in their histology are excluded * Patients who have had chemotherapy for the treatment of the advanced or unresectable urothelial cancer of the bladder are not eligible; patients who were previously treated for local disease must not have received radiotherapy or chemotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study and must have recovered from adverse events due to agents administered more than 4 weeks earlier; patients who have received neoadjuvant or adjuvant chemotherapy must have completed treatment at least 6 months prior to diagnosis of metastatic disease * Patients who are receiving any other investigational agents * Patients with known brain metastases should be excluded from this clinical trial * History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine and eribulin * Uncontrolled intercurrent illness including, but not limited to, a second cancer diagnosis within the past 5 years, or a cancer undergoing any treatment, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with eribulin and gemcitabine * Human immunodeficiency virus (HIV)-positive patients with inadequate cluster of differentiation (CD)4 counts or those who are on combination antiretroviral therapy with strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) effects are ineligible for this trial * Patients with baseline corrected QT (QTc) prolongation greater than grade 1 are excluded from this study; patients with grade 1 QTc elevation are eligible but must be monitored with electrocardiogram (ECG) (EKG) exams, for the first 3 cycles of treatment; eribulin time to maximum concentration (Cmax) after infusion is about 10 minutes, and half life is 40 minutes; ECG (EKG) should be performed between 10 to 40 minutes after eribulin administration (on day 1 and day 8 of treatment); continued ECG (EKG) monitoring beyond cycle 3 can be done at the discretion of the treating physician * Patients with congenital long QT syndrome are excluded from this study * Other medications known to prolong QT interval should be discontinued and if not possible, patient is excluded from this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Observed Overall Response Rate | Up to 36 months | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Observed Overall Response Rate = Number of patients who experienced a confirmed CR or PR divided by the number of eligible patients who began treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival | From the start until progression, death, or the start of another treatment, assessed up to 12 months | Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
| Overall Survival | From start of treatment until death from any cause ,up to 36 months | Estimated using the product-limit method of Kaplan and Meier. |
| Incidence of Adverse Events. | Up to 36 months | Toxicities that Occurred in 10% or More of Patients or At Least Once as a Grade 3+ Adverse Event (excluding those toxicities classified as unrelated or unlikely related to study drugs). Toxicities graded using CTCAEv4 criteria. |
Countries
Canada, United States
Participant flow
Recruitment details
Twenty-six patients were enrolled, but 2 did not receive treatment due to medication compliance related to diabetes and another deemed ineligible after registration but prior to treatment start.
Participants by arm
| Arm | Count |
|---|---|
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) Patients receive 1000mg/m\^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 1.4mg/m\^2 eribulin mesylate IV over 2-5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Eribulin Mesylate: Given IV
Gemcitabine Hydrochloride: Given IV | 24 |
| Total | 24 |
Baseline characteristics
| Characteristic | Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) |
|---|---|
| Age, Continuous | 73 years |
| Race/Ethnicity, Customized Asian | 1 Participants |
| Race/Ethnicity, Customized Caucasian | 22 Participants |
| Race/Ethnicity, Customized Hispanic | 1 Participants |
| Region of Enrollment United States | 24 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 20 / 24 |
| other Total, other adverse events | 24 / 24 |
| serious Total, serious adverse events | 16 / 24 |
Outcome results
Primary
Observed Overall Response Rate
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Observed Overall Response Rate = Number of patients who experienced a confirmed CR or PR divided by the number of eligible patients who began treatment.
Time frame: Up to 36 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Observed Overall Response Rate | 50 percentage of participants |
Secondary
Incidence of Adverse Events.
Toxicities that Occurred in 10% or More of Patients or At Least Once as a Grade 3+ Adverse Event (excluding those toxicities classified as unrelated or unlikely related to study drugs). Toxicities graded using CTCAEv4 criteria.
Time frame: Up to 36 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 1 or 2 : Lung infection | 0 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 1 or 2 : Sepsis | 0 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 1 or 2 : Upper respiratory infection | 0 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 3 or 4 : Lung infection | 1 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 3 or 4 : Sepsis | 1 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 3 or 4 : Dizziness | 0 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 3 or 4 : Dyspnea | 1 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 1 or 2 : Anemia | 7 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 1 or 2 : Febrile neutropenia | 3 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 1 or 2 : Thrombotic microangiopathy | 1 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 1 or 2 : Chest pain - cardiac | 0 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 1 or 2 : Heart failure | 0 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 1 or 2 : Colitis | 0 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 1 or 2 : Constipation | 10 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 1 or 2 : Diarrhea | 7 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 1 or 2 : Dry Mouth | 4 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 1 or 2 : Mucositis oral | 2 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 1 or 2 : Nausea | 7 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 1 or 2 : Vomiting | 2 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 1 or 2 : Edema | 9 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 1 or 2 : Fatigue | 13 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 1 or 2 : Fever | 4 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 1 or 2 : Appendicitis perforated | 0 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 1 or 2 : Urinary Tract Infection | 1 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 1 or 2 : Electrocardiogram QT | 2 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 1 or 2 : Weight Loss | 4 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 1 or 2 : Lymphocyte Count Decreased | 4 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 1 or 2 : Neutrophil Count Decreased | 4 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 1 or 2 : Platelet Count Decreased | 7 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 1 or 2 : White Blood Cell Decreased | 7 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 1 or 2 : INR increased | 1 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 1 or 2 : Alanine Aminotransferase Increased | 9 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 1 or 2 : Aspartate Aminotransferase Incr | 11 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 1 or 2 : Creatinine Increased | 4 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 1 or 2 : Anorexia | 9 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 1 or 2 : Hyperglycemia | 0 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 1 or 2 : Dehydration | 3 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 1 or 2 : Hypoalbuminemia | 8 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 1 or 2 : Hypocalcemia | 4 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 1 or 2 : Hypokalemia | 4 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 1 or 2 : Hypomagnesemia | 3 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 1 or 2 : Hyponatremia | 7 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 3 or 4 : Paresthesia | 1 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 1 or 2 : Hypophosphatemia | 4 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 1 or 2 : Generalized Muscle Weakness | 5 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 1 or 2 : Grip Weakness | 0 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 1 or 2 : Pain in Extremity | 3 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 1 or 2 : Dizziness | 5 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 1 or 2 : Dysgeusia | 4 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 1 or 2 : Paresthesia | 4 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 1 or 2 : Peripheral Sensory Neuropathy | 5 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 1 or 2 : Insomnia | 3 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 1 or 2 : Dyspnea | 0 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 1 or 2 : Pneumonitis | 0 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 1 or 2 : Sore Throat | 3 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 1 or 2 : Alopecia | 12 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 1 or 2 : Hypotension | 2 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 1 or 2 : Thromboembolic event | 0 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 3 or 4 : Anemia | 8 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 3 or 4 : Febrile neutropenia | 0 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 3 or 4 : Thrombotic microangiopathy | 0 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 3 or 4 : Chest pain - cardiac | 1 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 3 or 4 : Heart failure | 1 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 3 or 4 : Colitis | 1 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 3 or 4 : Constipation | 0 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 3 or 4 : Diarrhea | 2 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 3 or 4 : Dry Mouth | 0 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 3 or 4 : Mucositis oral | 2 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 3 or 4 : Nausea | 3 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 3 or 4 : Vomiting | 2 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 3 or 4 : Edema | 1 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 3 or 4 : Fatigue | 7 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 3 or 4 : Fever | 0 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 3 or 4 : Appendicitis perforated | 1 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 3 or 4 : Upper respiratory infection | 1 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 3 or 4 : Urinary Tract Infection | 2 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 3 or 4 : Electrocardiogram QT | 1 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 3 or 4 : Weight Loss | 0 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 3 or 4 : Lymphocyte Count Decreased | 6 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 3 or 4 : Neutrophil Count Decreased | 15 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 3 or 4 : Platelet Count Decreased | 3 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 3 or 4 : White Blood Cell Decreased | 13 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 3 or 4 : INR increased | 1 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 3 or 4 : Alanine Aminotransferase Increased | 0 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 3 or 4 : Aspartate Aminotransferase Incr | 1 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 3 or 4 : Creatinine Increased | 0 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 3 or 4 : Anorexia | 0 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 3 or 4 : Hyperglycemia | 1 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 3 or 4 : Dehydration | 2 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 3 or 4 : Hypoalbuminemia | 1 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 3 or 4 : Hypocalcemia | 0 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 3 or 4 : Hypokalemia | 0 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 3 or 4 : Hypomagnesemia | 0 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 3 or 4 : Hyponatremia | 2 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 3 or 4 : Hypophosphatemia | 0 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 3 or 4 : Generalized Muscle Weakness | 1 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 3 or 4 : Grip Weakness | 1 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 3 or 4 : Pain in Extremity | 1 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 3 or 4 : Dysgeusia | 0 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 3 or 4 : Peripheral Sensory Neuropathy | 0 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 3 or 4 : Insomnia | 0 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 3 or 4 : Pneumonitis | 1 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 3 or 4 : Sore Throat | 0 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 3 or 4 : Alopecia | 0 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 3 or 4 : Hypotension | 1 participants |
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Incidence of Adverse Events. | Grade 3 or 4 : Thromboembolic event | 1 participants |
Secondary
Overall Survival
Estimated using the product-limit method of Kaplan and Meier.
Time frame: From start of treatment until death from any cause ,up to 36 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Overall Survival | 11.9 months |
Secondary
Progression-free Survival
Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: From the start until progression, death, or the start of another treatment, assessed up to 12 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) | Progression-free Survival | 5.3 months |