Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter, Urethral Cancer
Conditions
Keywords
recurrent bladder cancer, stage IV bladder cancer, transitional cell carcinoma of the bladder, squamous cell carcinoma of the bladder, adenocarcinoma of the bladder, recurrent urethral cancer, anterior urethral cancer, posterior urethral cancer, urethral cancer associated with invasive bladder cancer, metastatic transitional cell cancer of the renal pelvis and ureter, regional transitional cell cancer of the renal pelvis and ureter, recurrent transitional cell cancer of the renal pelvis and ureter
Brief summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine and paclitaxel in treating patients who have advanced or recurrent cancer of the urinary tract.
Detailed description
OBJECTIVES: * Determine the feasibility of enrolling patients aged 70 years and older with advanced or recurrent urothelial cancer to a structured phase II study. * Determine the anticancer efficacy of gemcitabine and paclitaxel, in terms of objective response rate and 2-year survival, in these elderly patients. * Assess the toxicity and tolerability of this regimen in these elderly patients. * Determine the feasibility of using standardized self-report measures of comorbidity, depression, and functional status in these patients. * Determine the pharmacokinetics of this regimen in these elderly patients and validate this data against similar parameters in patients aged under 60 years. OUTLINE: This is a multicenter study. Patients are stratified according to age (70 and over vs under 60). Patients receive paclitaxel IV over 3 hours on day 1 and gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline. Patients are followed every 3 months for 1 year and then every 6 months for 2 years. PROJECTED ACCRUAL: A total of 80 patients (60 age 70 and over and 20 under age 60) will be accrued for this study.
Interventions
DRUGgemcitabine hydrochloride
DRUGpaclitaxel
Sponsors
National Cancer Institute (NCI)
SWOG Cancer Research Network
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 120 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed urothelial cancer * Transitional cell carcinoma, adenocarcinoma, or squamous carcinoma (bladder, renal pelvis, ureter, or urethra) * Previously untreated metastatic or locoregionally advanced (i.e., bulky pelvic nodes) disease OR * Locally recurrent carcinoma after radiotherapy or cystectomy and no longer eligible for further radiotherapy or surgery * Measurable disease PATIENT CHARACTERISTICS: Age: * 70 and over OR * Under 60 Performance status: * Zubrod 0-2 Life expectancy: * Not specified Hematopoietic: * Absolute granulocyte count at least 1,200/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than upper limit of normal (ULN) * Aspartate aminotransferase (SGOT) or alanine aminotransferase (SGPT) no greater than 2 times ULN Renal: * Creatinine no greater than ULN Other: * HIV negative * No other concurrent life-threatening medical disorder that would preclude study participation * No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Prior adjuvant chemotherapy is allowed provided administered more than 10 years ago * No prior gemcitabine, taxanes, or platinum-based adjuvant chemotherapy Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics * At least 28 days since prior radiotherapy and recovered Surgery: * See Disease Characteristics * At least 28 days since prior surgery and recovered
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine the Feasibility of Accruing Patients With Metastatic Bladder Cancer Who Are 70 and Older to Chemotherapy Protocols | 66 months (protocol activated on 7/1/2001 and closed to accrual on 12/15/2006) | Sixty patients aged 70 years and older were to be accrued to the study. The feasibility of accrual was determined that accrual of 3 patients per month in the age 70 and older range would allow for an expeditiously conducted phase II trial. If, after a 3 month start-up period, 3 or more patients aged 70 years and older were accrued per month for the duration of the trial, it was deemed reasonable to consider further trials in this elderly population. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival in Patients Aged 70 Years and Older | 0-5 years | Measured form date of registration to date of first observation of progression disease, death due to any cause, symptomatic deterioration, or early discontinuation of treatment. |
| Overall Survival (OS) in Patients Aged 70 Years and Older | 0-5 years | Measured from date of registration to date of death due to any cause. |
| Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment. | Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 2.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal. |
| Overall Confirmed Response Rate in the Patients Age 70 and Older (Complete and Partial Response) | every week for the first 4 weeks and then every 3 weeks for up to 19 weeks | Complete response (CR) is defined as complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Partial response (PR) applies only to patients with least one measurable lesion. Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. |
| Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: Median Time of Complete Forms | at study entry (prior to administration of any treatment) | Patients were required to complete three self-administered questionnaires at entry, prior to the administration of any cytotoxic therapy: the Medical Conditions Questionnaire, Instrumental Activities of Daily Living Form that evaluates functional status, and the Feelings Questionnaire that evaluates depression status. Feasibility is defined in four ways: 1) submission rates for the each of three patient self-administered questionnaires (\> 60%); 2) the number of items missing within each scale (\< 5%); 3) a description of the level of assistance required for self-administration of the questionnaires; and 4) the average amount of time it takes patients to complete each of the three questionnaires. Level of assistance is defined as the need to 1) read the questionnaire to the patient, 2) explain the meaning of items, 3) explain the response format, and 4) complete the questionnaire for the patient; an other category of assistance will be included. |
| Assess the Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: at Least One Type of Assistance Required | at study entry (prior to administration of any treatment) | Patients were required to complete three self-administered questionnaires at entry, prior to the administration of any cytotoxic therapy: the Medical Conditions Questionnaire, Instrumental Activities of Daily Living Form that evaluates functional status, and the Feelings Questionnaire that evaluates depression status. Feasibility is defined in four ways: 1) submission rates for the three patient self-administered questionnaires (\> 60%); 2) the number of items missing within each scale (\< 5%); 3) a description of the level of assistance required for self-administration of the questionnaires; and 4) the average amount of time it takes patients to complete each of the three questionnaires. Level of assistance is defined as the need to 1) read the questionnaire to the patient, 2) explain the meaning of items, 3) explain the response format, and 4) complete the questionnaire for the patient; an other category of assistance will be included. |
| Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: Form Submission Rate | at study entry (prior to administration of any treatment) | Patients were required to complete three self-administered questionnaires at entry, prior to the administration of any cytotoxic therapy: the Medical Conditions Questionnaire, Instrumental Activities of Daily Living Form that evaluates functional status, and the Feelings Questionnaire that evaluates depression status. Feasibility is defined in four ways: 1) submission rates for each of three patient self-administered questionnaires (\> 60%); 2) the number of items missing within each scale (\< 5%); 3) a description of the level of assistance required for self-administration of the questionnaires; and 4) the average amount of time it takes patients to complete each of the three questionnaires. Level of assistance is defined as the need to 1) read the questionnaire to the patient, 2) explain the meaning of items, 3) explain the response format, and 4) complete the questionnaire for the patient; an other category of assistance will be included. |
Countries
United States
Participant flow
Recruitment details
The purpose of the subset of patients who aged 60 years or younger was to serve as a younger reference group for the pharmacokinetic parameter estimation. Therefore, this younger cohort is not included in analyses of adverse event, efficacy, and feasibility assessment of patient-reported outcome measures.
Participants by arm
| Arm | Count |
|---|---|
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) Patients received 1000 mg /m\^2 of gemcitabine on Day 1 and 8 and 175 mg/m\^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days) | 51 |
| Paclitaxel + Gemcitabine (Younger Cohort: Age < 60) Patients received 1000 mg /m\^2 of gemcitabine on Day 1 and 8 and 175 mg/m\^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days) | 10 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 11 | 1 |
| Overall Study | Death | 4 | 0 |
| Overall Study | Ineligible | 4 | 0 |
| Overall Study | Other - not protocol specified | 3 | 2 |
| Overall Study | Progression/relapse | 9 | 2 |
| Overall Study | Refusal unrelated to adverse event | 1 | 0 |
Baseline characteristics
| Characteristic | Total | Paclitaxel + Gemcitabine (Younger Cohort: Age < 60) | Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) |
|---|---|---|---|
| Age, Continuous | 74.6 years | 53.8 years | 76.1 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 56 Participants | 9 Participants | 47 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 53 Participants | 7 Participants | 46 Participants |
| Sex: Female, Male Female | 18 Participants | 4 Participants | 14 Participants |
| Sex: Female, Male Male | 43 Participants | 6 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 50 / 51 |
| serious Total, serious adverse events | 5 / 51 |
Outcome results
Primary
Determine the Feasibility of Accruing Patients With Metastatic Bladder Cancer Who Are 70 and Older to Chemotherapy Protocols
Sixty patients aged 70 years and older were to be accrued to the study. The feasibility of accrual was determined that accrual of 3 patients per month in the age 70 and older range would allow for an expeditiously conducted phase II trial. If, after a 3 month start-up period, 3 or more patients aged 70 years and older were accrued per month for the duration of the trial, it was deemed reasonable to consider further trials in this elderly population.
Time frame: 66 months (protocol activated on 7/1/2001 and closed to accrual on 12/15/2006)
Population: A total of 55 patients aged 70 years and older were registered to this protocol from July, 2001 to December, 2006.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | Determine the Feasibility of Accruing Patients With Metastatic Bladder Cancer Who Are 70 and Older to Chemotherapy Protocols | 55 participants |
Secondary
Assess the Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: at Least One Type of Assistance Required
Patients were required to complete three self-administered questionnaires at entry, prior to the administration of any cytotoxic therapy: the Medical Conditions Questionnaire, Instrumental Activities of Daily Living Form that evaluates functional status, and the Feelings Questionnaire that evaluates depression status. Feasibility is defined in four ways: 1) submission rates for the three patient self-administered questionnaires (\> 60%); 2) the number of items missing within each scale (\< 5%); 3) a description of the level of assistance required for self-administration of the questionnaires; and 4) the average amount of time it takes patients to complete each of the three questionnaires. Level of assistance is defined as the need to 1) read the questionnaire to the patient, 2) explain the meaning of items, 3) explain the response format, and 4) complete the questionnaire for the patient; an other category of assistance will be included.
Time frame: at study entry (prior to administration of any treatment)
Population: Eligible patients aged 70 years and older who had received any treatment were included in the analysis. One non-compliant patient who did not complete any of the forms was excluded. Patients aged 60 years or younger who served as a younger reference group for the pharmacokinetic study were excluded from analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | Assess the Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: at Least One Type of Assistance Required | Medical Conditions Questionnaire | 28 percentage of participants |
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | Assess the Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: at Least One Type of Assistance Required | Instrumental Activities of Daily Living Form | 42 percentage of participants |
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | Assess the Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: at Least One Type of Assistance Required | Feelings Questionnaire | 34 percentage of participants |
Secondary
Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: Form Submission Rate
Patients were required to complete three self-administered questionnaires at entry, prior to the administration of any cytotoxic therapy: the Medical Conditions Questionnaire, Instrumental Activities of Daily Living Form that evaluates functional status, and the Feelings Questionnaire that evaluates depression status. Feasibility is defined in four ways: 1) submission rates for each of three patient self-administered questionnaires (\> 60%); 2) the number of items missing within each scale (\< 5%); 3) a description of the level of assistance required for self-administration of the questionnaires; and 4) the average amount of time it takes patients to complete each of the three questionnaires. Level of assistance is defined as the need to 1) read the questionnaire to the patient, 2) explain the meaning of items, 3) explain the response format, and 4) complete the questionnaire for the patient; an other category of assistance will be included.
Time frame: at study entry (prior to administration of any treatment)
Population: Eligible patients aged 70 years and older who had received any treatment were included in the analysis. Patients aged 60 years or younger who served as a younger reference group for the pharmacokinetic study were excluded from analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: Form Submission Rate | Medical Conditions Questionnaire | 98 percentage of participants |
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: Form Submission Rate | Instrumental Activities of Daily Living Form | 98 percentage of participants |
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: Form Submission Rate | Feelings Questionnaire | 98 percentage of participants |
Secondary
Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: Median Time of Complete Forms
Patients were required to complete three self-administered questionnaires at entry, prior to the administration of any cytotoxic therapy: the Medical Conditions Questionnaire, Instrumental Activities of Daily Living Form that evaluates functional status, and the Feelings Questionnaire that evaluates depression status. Feasibility is defined in four ways: 1) submission rates for the each of three patient self-administered questionnaires (\> 60%); 2) the number of items missing within each scale (\< 5%); 3) a description of the level of assistance required for self-administration of the questionnaires; and 4) the average amount of time it takes patients to complete each of the three questionnaires. Level of assistance is defined as the need to 1) read the questionnaire to the patient, 2) explain the meaning of items, 3) explain the response format, and 4) complete the questionnaire for the patient; an other category of assistance will be included.
Time frame: at study entry (prior to administration of any treatment)
Population: Eligible patients aged 70 years and older who had received any treatment were included in the analysis. One non-compliant patient who did not complete any of the forms was excluded. Patients aged 60 years or younger who served as a younger reference group for the pharmacokinetic study were excluded from analysis.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: Median Time of Complete Forms | Medical Conditions Questionnaire | 5 minutes |
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: Median Time of Complete Forms | Instrumental Activities of Daily Living Form | 3 minutes |
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: Median Time of Complete Forms | Feelings Questionnaire | 2 minutes |
Secondary
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 2.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.
Time frame: Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment.
Population: Eligible patients aged 70 years and older who had received any treatment were included in the adverse event summaries. Any CTCAE 2.0 event of Grade 3, Grade 4, or Grade 5 which deemed to be related to protocol treatment are included. Patients aged 60 years or younger who served as a younger reference group for the pharmacokinetic study are excluded
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Abdominal pain/cramping | 2 Participants |
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Acidosis | 1 Participants |
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Allergic reaction | 1 Participants |
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Anemia | 6 Participants |
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Anorexia | 3 Participants |
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Bone pain | 1 Participants |
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Cardiac ischemia/infarction | 1 Participants |
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Chest pain,not cardio or pleur | 1 Participants |
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Confusion | 1 Participants |
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Diarrhea without colostomy | 1 Participants |
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Constipation/bowel obstruction | 2 Participants |
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Creatinine increase | 1 Participants |
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Dehydration | 1 Participants |
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Dizziness/light headedness | 1 Participants |
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Dyspepsia/heartburn | 1 Participants |
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Dyspnea | 6 Participants |
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Edema | 1 Participants |
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Fatigue/malaise/lethargy | 8 Participants |
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Febrile neutropenia | 1 Participants |
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Gastric ulcer | 1 Participants |
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hyperglycemia | 3 Participants |
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hyperkalemia | 2 Participants |
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hypotension | 2 Participants |
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Infection w/o 3-4 neutropenia | 1 Participants |
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Infection with 3-4 neutropenia | 3 Participants |
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Infection, unk ANC | 1 Participants |
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Leukopenia | 6 Participants |
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Muscle weakness (not neuro) | 1 Participants |
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Myalgia/arthralgia, NOS | 1 Participants |
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Nausea | 3 Participants |
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Neuropathic pain | 1 Participants |
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Neutropenia/granulocytopenia | 26 Participants |
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | PRBC transfusion | 10 Participants |
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain-other | 3 Participants |
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pleural effusions | 1 Participants |
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pneumonitis/infiltrates | 1 Participants |
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Renal failure | 1 Participants |
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Respiratory infect w/ neutrop | 1 Participants |
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | SGOT (AST) increase | 1 Participants |
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Sensory neuropathy | 3 Participants |
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Supraventricular arrhythmia | 1 Participants |
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Thrombocytopenia | 2 Participants |
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Thrombosis/embolism | 2 Participants |
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Urinary tr infect w/ neutrop | 2 Participants |
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Urinary tr infect w/o neutrop | 2 Participants |
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Ventricular arrhythmia | 2 Participants |
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Vomiting | 1 Participants |
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Weakness (motor neuropathy) | 2 Participants |
Secondary
Overall Confirmed Response Rate in the Patients Age 70 and Older (Complete and Partial Response)
Complete response (CR) is defined as complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Partial response (PR) applies only to patients with least one measurable lesion. Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions.
Time frame: every week for the first 4 weeks and then every 3 weeks for up to 19 weeks
Population: Eligible patients aged 70 years and older who had received any treatment were included in the analysis. Patients aged 60 years or younger who served as a younger reference group for the pharmacokinetic study were excluded from analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | Overall Confirmed Response Rate in the Patients Age 70 and Older (Complete and Partial Response) | 22 percentage of participants |
Secondary
Overall Survival (OS) in Patients Aged 70 Years and Older
Measured from date of registration to date of death due to any cause.
Time frame: 0-5 years
Population: Eligible patients aged 70 years and older who had received any treatment were included in the analysis. Patients aged 60 years or younger who served as a younger reference group for the pharmacokinetic study were excluded from analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | Overall Survival (OS) in Patients Aged 70 Years and Older | 11 months |
Secondary
Progression-free Survival in Patients Aged 70 Years and Older
Measured form date of registration to date of first observation of progression disease, death due to any cause, symptomatic deterioration, or early discontinuation of treatment.
Time frame: 0-5 years
Population: Eligible patients aged 70 years and older who had received any treatment were included in the analysis. Patients aged 60 years or younger who served as a younger reference group for the pharmacokinetic study were excluded from analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | Progression-free Survival in Patients Aged 70 Years and Older | 6 months |