A Phase 2 interventional study of gemcitabine hydrochloride and paclitaxel in Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter and Urethral Cancer, sponsored by SWOG Cancer Research Network. Terminated at 92 sites in United States. Open to participants aged Up to 120 Years. Per ClinicalTrials.gov, last updated 2016-08-11.
Sponsored by SWOG Cancer Research Network · Phase 2, Interventional, and Treatment
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.
OBJECTIVES:
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.
1,617 studies on the registry are indexed under Urinary Bladder Neoplasms; 422 are open to participants now.
This study's enrollment of 65 is close to the median of 60 across 1,163 interventional studies indexed under Urinary Bladder Neoplasms.
Browse Urinary Bladder Neoplasms studies →SWOG Cancer Research Network is the lead sponsor of 328 studies on the registry; 37 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 17 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically confirmed urothelial cancer
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Drug: gemcitabine hydrochloride · Drug: paclitaxel
Also known as: Taxol
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)
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
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
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
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.
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)
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)
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)
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.
| Milestone | Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | Paclitaxel + Gemcitabine (Younger Cohort: Age < 60) |
|---|---|---|
| Started | 55 | 10 |
| Eligible | 51 | 10 |
| Completed | 23 | 5 |
| Not completed | 32 | 5 |
| Withdrew: Adverse event | 11 | 1 |
| Withdrew: Refusal unrelated to adverse event | 1 | 0 |
| Withdrew: Progression/relapse | 9 | 2 |
| Withdrew: Death | 4 | 0 |
| Withdrew: Other - not protocol specified | 3 | 2 |
| Withdrew: Ineligible | 4 | 0 |
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.
| percentage of participants | Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) |
|---|---|
| Overall Confirmed Response Rate in the Patients Age 70 and Older (Complete and Partial Response) | 22 (11 to 35) |
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.
| months | Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) |
|---|---|
| Progression-free Survival in Patients Aged 70 Years and Older | 6 (4 to 7) |
Measured from date of registration to date of death due to any cause.
| months | Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) |
|---|---|
| Overall Survival (OS) in Patients Aged 70 Years and Older | 11 (8 to 13) |
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.
| Participants | Paclitaxel + Gemcitabine |
|---|---|
| Abdominal pain/cramping | 2 |
| Acidosis | 1 |
| Allergic reaction | 1 |
| Anemia | 6 |
| Anorexia | 3 |
| Bone pain | 1 |
| Cardiac ischemia/infarction | 1 |
| Chest pain,not cardio or pleur | 1 |
| Confusion | 1 |
| Constipation/bowel obstruction | 2 |
| Creatinine increase | 1 |
| Dehydration | 1 |
| Diarrhea without colostomy | 1 |
| Dizziness/light headedness | 1 |
| Dyspepsia/heartburn | 1 |
| Dyspnea | 6 |
| Edema | 1 |
| Fatigue/malaise/lethargy | 8 |
| Febrile neutropenia | 1 |
| Gastric ulcer | 1 |
| Hyperglycemia | 3 |
| Hyperkalemia | 2 |
| Hypotension | 2 |
| Infection w/o 3-4 neutropenia | 1 |
| Infection with 3-4 neutropenia | 3 |
| Infection, unk ANC | 1 |
| Leukopenia | 6 |
| Muscle weakness (not neuro) | 1 |
| Myalgia/arthralgia, NOS | 1 |
| Nausea | 3 |
| Neuropathic pain | 1 |
| Neutropenia/granulocytopenia | 26 |
| PRBC transfusion | 10 |
| Pain-other | 3 |
| Pleural effusions | 1 |
| Pneumonitis/infiltrates | 1 |
| Renal failure | 1 |
| Respiratory infect w/ neutrop | 1 |
| SGOT (AST) increase | 1 |
| Sensory neuropathy | 3 |
| Supraventricular arrhythmia | 1 |
| Thrombocytopenia | 2 |
| Thrombosis/embolism | 2 |
| Urinary tr infect w/ neutrop | 2 |
| Urinary tr infect w/o neutrop | 2 |
| Ventricular arrhythmia | 2 |
| Vomiting | 1 |
| Weakness (motor neuropathy) | 2 |
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.
| participants | 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 |
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.
| percentage of participants | Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) |
|---|---|
| Medical Conditions Questionnaire | 98 |
| Instrumental Activities of Daily Living Form | 98 |
| Feelings Questionnaire | 98 |
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.
| minutes | Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) |
|---|---|
| Medical Conditions Questionnaire | 5 (1 to 45) |
| Instrumental Activities of Daily Living Form | 3 (1 to 45) |
| Feelings Questionnaire | 2 (1 to 30) |
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.
| percentage of participants | Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) |
|---|---|
| Medical Conditions Questionnaire | 28 |
| Instrumental Activities of Daily Living Form | 42 |
| Feelings Questionnaire | 34 |
Collected over 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.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Paclitaxel + Gemcitabine | — | 5/51 (9.8%) | 50/51 (98%) |
| Event | Paclitaxel + Gemcitabine |
|---|---|
| Reportable adverse event, NOSGeneral disorders | 2/51 |
| Cardiovascular-otherCardiac disorders | 1/51 |
| Supraventricular arrhythmiaCardiac disorders | 1/51 |
| IleusGastrointestinal disorders | 1/51 |
| Flu-like symptoms-otherGeneral disorders | 1/51 |
| Respiratory infect w/ neutropInfections and infestations | 1/51 |
| AcidosisMetabolism and nutrition disorders | 1/51 |
| DehydrationMetabolism and nutrition disorders | 1/51 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 1/51 |
| Event | Paclitaxel + Gemcitabine |
|---|---|
| Fatigue/malaise/lethargyGeneral disorders | 42/51 |
| Neutropenia/granulocytopeniaInvestigations | 36/51 |
| AnemiaBlood and lymphatic system disorders | 29/51 |
| AlopeciaSkin and subcutaneous tissue disorders | 27/51 |
| NauseaGastrointestinal disorders | 25/51 |
| AnorexiaMetabolism and nutrition disorders | 23/51 |
| Sensory neuropathyNervous system disorders | 21/51 |
| ThrombocytopeniaInvestigations | 20/51 |
| MyalgiaMusculoskeletal and connective tissue disorders | 20/51 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 17/51 |
All eligible patients who started treatment were included in the analysis
| Age, Continuous(years) | Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | Paclitaxel + Gemcitabine (Younger Cohort: Age < 60) | Total |
|---|---|---|---|
| Median | 76.1 (70.1 to 85.2) | 53.8 (31.2 to 59.7) | 74.6 (31.2 to 85.2) |
| Sex: Female, Male(Participants) | Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | Paclitaxel + Gemcitabine (Younger Cohort: Age < 60) | Total |
|---|---|---|---|
| Female | 14 | 4 | 18 |
| Male | 37 | 6 | 43 |
| Ethnicity (NIH/OMB)(Participants) | Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | Paclitaxel + Gemcitabine (Younger Cohort: Age < 60) | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 1 | 4 |
| Not Hispanic or Latino | 47 | 9 | 56 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | Paclitaxel + Gemcitabine (Younger Cohort: Age < 60) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 4 | 1 | 5 |
| White | 46 | 7 | 53 |
| More than one race | 0 | 1 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
This study is terminated, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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