Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

S0028, Gemcitabine and Paclitaxel in Treating Patients With Advanced or Recurrent Cancer of the Urinary Tract

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00022633
Recruitment Status : Terminated (Permanently Closed Due to Poor Accrual)
First Posted : January 27, 2003
Results First Posted : February 24, 2016
Last Update Posted : August 11, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Bladder Cancer
Transitional Cell Cancer of the Renal Pelvis and Ureter
Urethral Cancer
Interventions Drug: gemcitabine hydrochloride
Drug: paclitaxel
Enrollment 65
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.
Pre-assignment Details  
Arm/Group Title Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) Paclitaxel + Gemcitabine (Younger Cohort: Age < 60)
Hide Arm/Group Description 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) 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)
Period Title: Overall Study
Started 55 10
Eligible 51 10
Completed 23 5
Not Completed 32 5
Reason Not Completed
Adverse Event             11             1
Refusal unrelated to adverse event             1             0
Progression/relapse             9             2
Death             4             0
Other - not protocol specified             3             2
Ineligible             4             0
Arm/Group Title Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) Paclitaxel + Gemcitabine (Younger Cohort: Age < 60) Total
Hide Arm/Group Description 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) 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) Total of all reporting groups
Overall Number of Baseline Participants 51 10 61
Hide Baseline Analysis Population Description
All eligible patients who started treatment were included in the analysis
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 51 participants 10 participants 61 participants
76.1
(70.1 to 85.2)
53.8
(31.2 to 59.7)
74.6
(31.2 to 85.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 10 participants 61 participants
Female
14
  27.5%
4
  40.0%
18
  29.5%
Male
37
  72.5%
6
  60.0%
43
  70.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 10 participants 61 participants
Hispanic or Latino
3
   5.9%
1
  10.0%
4
   6.6%
Not Hispanic or Latino
47
  92.2%
9
  90.0%
56
  91.8%
Unknown or Not Reported
1
   2.0%
0
   0.0%
1
   1.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 10 participants 61 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   2.0%
0
   0.0%
1
   1.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
  10.0%
1
   1.6%
Black or African American
4
   7.8%
1
  10.0%
5
   8.2%
White
46
  90.2%
7
  70.0%
53
  86.9%
More than one race
0
   0.0%
1
  10.0%
1
   1.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Determine the Feasibility of Accruing Patients With Metastatic Bladder Cancer Who Are 70 and Older to Chemotherapy Protocols
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 55 patients aged 70 years and older were registered to this protocol from July, 2001 to December, 2006.
Arm/Group Title Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 55
Measure Type: Number
Unit of Measure: participants
55
2.Secondary Outcome
Title Overall Confirmed Response Rate in the Patients Age 70 and Older (Complete and Partial Response)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 51
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
22
(11 to 35)
3.Secondary Outcome
Title Progression-free Survival in Patients Aged 70 Years and Older
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 51
Median (95% Confidence Interval)
Unit of Measure: months
6
(4 to 7)
4.Secondary Outcome
Title Overall Survival (OS) in Patients Aged 70 Years and Older
Hide Description Measured from date of registration to date of death due to any cause.
Time Frame 0-5 years
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 51
Median (95% Confidence Interval)
Unit of Measure: months
11
(8 to 13)
5.Secondary Outcome
Title Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Paclitaxel + Gemcitabine
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 51
Measure Type: Number
Unit of Measure: Participants
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
6.Secondary Outcome
Title Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: Form Submission Rate
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 51
Measure Type: Number
Unit of Measure: percentage of participants
Medical Conditions Questionnaire 98
Instrumental Activities of Daily Living Form 98
Feelings Questionnaire 98
7.Secondary Outcome
Title Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: Median Time of Complete Forms
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 50
Median (Full Range)
Unit of Measure: minutes
Medical Conditions Questionnaire
5
(1 to 45)
Instrumental Activities of Daily Living Form
3
(1 to 45)
Feelings Questionnaire
2
(1 to 30)
8.Secondary Outcome
Title Assess the Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: at Least One Type of Assistance Required
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: percentage of participants
Medical Conditions Questionnaire 28
Instrumental Activities of Daily Living Form 42
Feelings Questionnaire 34
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.
Adverse Event Reporting Description Elderly Cohort (Age >= 70 years)
 
Arm/Group Title Paclitaxel + Gemcitabine
Hide Arm/Group Description 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)
All-Cause Mortality
Paclitaxel + Gemcitabine
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Paclitaxel + Gemcitabine
Affected / at Risk (%)
Total   5/51 (9.80%) 
Cardiac disorders   
Cardiovascular-other  1  1/51 (1.96%) 
Supraventricular arrhythmia  1  1/51 (1.96%) 
Gastrointestinal disorders   
Ileus  1  1/51 (1.96%) 
General disorders   
Flu-like symptoms-other  1  1/51 (1.96%) 
Reportable adverse event, NOS  1  2/51 (3.92%) 
Infections and infestations   
Respiratory infect w/ neutrop  1  1/51 (1.96%) 
Metabolism and nutrition disorders   
Acidosis  1  1/51 (1.96%) 
Dehydration  1  1/51 (1.96%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  1/51 (1.96%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (2.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Paclitaxel + Gemcitabine
Affected / at Risk (%)
Total   50/51 (98.04%) 
Blood and lymphatic system disorders   
Anemia  1  29/51 (56.86%) 
PRBC transfusion  1  10/51 (19.61%) 
Eye disorders   
Blurred vision  1  4/51 (7.84%) 
Gastrointestinal disorders   
Abdominal pain/cramping  1  6/51 (11.76%) 
Constipation/bowel obstruction  1  16/51 (31.37%) 
Diarrhea without colostomy  1  12/51 (23.53%) 
Esophagitis/dysphagia  1  3/51 (5.88%) 
Nausea  1  25/51 (49.02%) 
Stomatitis/pharyngitis  1  4/51 (7.84%) 
Vomiting  1  9/51 (17.65%) 
General disorders   
Edema  1  14/51 (27.45%) 
Fatigue/malaise/lethargy  1  42/51 (82.35%) 
Fever without neutropenia  1  8/51 (15.69%) 
Pain-other  1  8/51 (15.69%) 
Rigors/chills  1  6/51 (11.76%) 
Sweating  1  4/51 (7.84%) 
Immune system disorders   
Allergic reaction  1  3/51 (5.88%) 
Infections and infestations   
Infection with 3-4 neutropenia  1  3/51 (5.88%) 
Urinary tr infect w/o neutrop  1  4/51 (7.84%) 
Investigations   
Alkaline phosphatase increase  1  8/51 (15.69%) 
Creatinine increase  1  7/51 (13.73%) 
Leukopenia  1  12/51 (23.53%) 
Neutropenia/granulocytopenia  1  36/51 (70.59%) 
SGOT (AST) increase  1  11/51 (21.57%) 
SGPT (ALT) increase  1  4/51 (7.84%) 
Thrombocytopenia  1  20/51 (39.22%) 
Weight loss  1  6/51 (11.76%) 
Metabolism and nutrition disorders   
Anorexia  1  23/51 (45.10%) 
Hyperglycemia  1  7/51 (13.73%) 
Hyperkalemia  1  3/51 (5.88%) 
Hypoalbuminemia  1  4/51 (7.84%) 
Hypocalcemia  1  3/51 (5.88%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  9/51 (17.65%) 
Bone pain  1  3/51 (5.88%) 
Myalgia  1  20/51 (39.22%) 
Nervous system disorders   
Dizziness/light headedness  1  8/51 (15.69%) 
Headache  1  5/51 (9.80%) 
Neuropathic pain  1  4/51 (7.84%) 
Sensory neuropathy  1  21/51 (41.18%) 
Taste disturbance  1  4/51 (7.84%) 
Weakness (motor neuropathy)  1  5/51 (9.80%) 
Psychiatric disorders   
Confusion  1  4/51 (7.84%) 
Insomnia  1  12/51 (23.53%) 
Renal and urinary disorders   
Urinary frequency/urgency  1  3/51 (5.88%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  9/51 (17.65%) 
Dyspnea  1  17/51 (33.33%) 
Hiccoughs  1  3/51 (5.88%) 
Skin and subcutaneous tissue disorders   
Alopecia  1  27/51 (52.94%) 
Rash/desquamation  1  4/51 (7.84%) 
Vascular disorders   
Hypotension  1  3/51 (5.88%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (2.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Derek Raghavan
Organization: Cleveland Clinic
Phone: 216-445-6888
EMail: raghavd@cc.ccf.org
Layout table for additonal information
Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00022633     History of Changes
Other Study ID Numbers: CDR0000068837
S0028 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
First Submitted: August 10, 2001
First Posted: January 27, 2003
Results First Submitted: November 26, 2012
Results First Posted: February 24, 2016
Last Update Posted: August 11, 2016