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S0353, Gemcitabine in Treating Patients With Recurrent Bladder Cancer That Has Not Responded to Previous Bacillus Calmette-Guerin

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ClinicalTrials.gov Identifier: NCT00234039
Recruitment Status : Completed
First Posted : October 6, 2005
Results First Posted : December 18, 2012
Last Update Posted : January 8, 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
Condition Bladder Cancer
Intervention Drug: gemcitabine hydrochloride
Enrollment 58
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intravesical Gemcitabine
Hide Arm/Group Description Patients receive induction treatment with instillations of 2 gm gemcitabine dissolved in 100 cc normal saline weekly for 6 weeks. Beginning at week 14, patients achieving a complete response (CR) after induction go onto maintenance and are treated with one intravesical gemcitabine every 4 weeks for 40 weeks.
Period Title: Overall Study
Started 58
Eligible 49
Eligible and Began Protocol Therapy 47
Completed 8
Not Completed 50
Reason Not Completed
Adverse Event             2
Progression/relapse             34
Other - Not Protocol Specified             3
Ineligible             9
No Protocol Treatment Received             2
Arm/Group Title Intravesical Gemcitabine
Hide Arm/Group Description Patients receive induction treatment with instillations of 2 gm gemcitabine dissolved in 100 cc normal saline weekly for 6 weeks. Beginning at week 14, patients achieving a complete response (CR) after induction go onto maintenance and are treated with one intravesical gemcitabine every 4 weeks for 40 weeks.
Overall Number of Baseline Participants 47
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 47 participants
70
(50 to 88)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants
Female
14
  29.8%
Male
33
  70.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
45
  95.7%
Unknown or Not Reported
2
   4.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants
American Indian or Alaska Native
0
   0.0%
Asian
3
   6.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
43
  91.5%
More than one race
1
   2.1%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Complete Response Rate at the End of Induction
Hide Description Complete Response is defined as negative cystoscopy with negative biopsy and no evidence of cancer on urine cytology at the Week 8 - 12 cystoscopy
Time Frame Week 8-12, then every 3 months for the first 2 years, and then every 6 months for the years 3-5
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients who started treatment were included in the analysis
Arm/Group Title Intravesical Gemcitabine
Hide Arm/Group Description:
Patients receive induction treatment with instillations of 2 gm gemcitabine dissolved in 100 cc normal saline weekly for 6 weeks. Beginning at week 14, patients achieving a complete response (CR) after induction go onto maintenance and are treated with one intravesical gemcitabine every 4 weeks for 40 weeks.
Overall Number of Participants Analyzed 47
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
46
(30 to 60)
2.Secondary Outcome
Title Overall Survival (OS)
Hide Description Measured from the day of registration to death due to any cause. Survival is censored at date of last contact.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients who started treatment were included in the analysis
Arm/Group Title Intravesical Gemcitabine
Hide Arm/Group Description:
Patients receive induction treatment with instillations of 2 gm gemcitabine dissolved in 100 cc normal saline weekly for 6 weeks. Beginning at week 14, patients achieving a complete response (CR) after induction go onto maintenance and are treated with one intravesical gemcitabine every 4 weeks for 40 weeks.
Overall Number of Participants Analyzed 47
Measure Type: Number
Unit of Measure: percentage of participants
98
3.Secondary Outcome
Title Recurrence-free Survival (RFS)
Hide Description Recurrence-free Survival is defined as time from registration to first instance of disease recurrence, or death due to any cause.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients who started treatment were included in the analysis
Arm/Group Title Intravesical Gemcitabine
Hide Arm/Group Description:
Patients receive induction treatment with instillations of 2 gm gemcitabine dissolved in 100 cc normal saline weekly for 6 weeks. Beginning at week 14, patients achieving a complete response (CR) after induction go onto maintenance and are treated with one intravesical gemcitabine every 4 weeks for 40 weeks.
Overall Number of Participants Analyzed 47
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
28
(16 to 43)
4.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 3.0. 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 for 6 weeks and then every 4 weeks for 40 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.
Arm/Group Title Intravesical Gemcitabine
Hide Arm/Group Description:
Patients receive induction treatment with instillations of 2 gm gemcitabine dissolved in 100 cc normal saline weekly for 6 weeks. Beginning at week 14, patients achieving a complete response (CR) after induction go onto maintenance and are treated with one intravesical gemcitabine every 4 weeks for 40 weeks.
Overall Number of Participants Analyzed 47
Measure Type: Number
Unit of Measure: Participants
Neutrophils/granulocytes (ANC/AGC) 1
Pain - Bladder 1
Urinary frequency/urgency 2
Time Frame Patients were assessed for adverse events weekly for 6 weeks and then every 4 weeks for 40 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intravesical Gemcitabine
Hide Arm/Group Description Patients receive induction treatment with instillations of 2 gm gemcitabine dissolved in 100 cc normal saline weekly for 6 weeks. Beginning at week 14, patients achieving a complete response (CR) after induction go onto maintenance and are treated with one intravesical gemcitabine every 4 weeks for 40 weeks.
All-Cause Mortality
Intravesical Gemcitabine
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Intravesical Gemcitabine
Affected / at Risk (%)
Total   0/47 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Intravesical Gemcitabine
Affected / at Risk (%)
Total   32/47 (68.09%) 
Blood and lymphatic system disorders   
Hemoglobin  1  3/47 (6.38%) 
Gastrointestinal disorders   
Constipation  1  3/47 (6.38%) 
Nausea  1  4/47 (8.51%) 
General disorders   
Fatigue (asthenia, lethargy, malaise)  1  9/47 (19.15%) 
Pain-Other (Specify)  1  3/47 (6.38%) 
Investigations   
Platelets  1  3/47 (6.38%) 
Nervous system disorders   
Dizziness  1  3/47 (6.38%) 
Renal and urinary disorders   
Bladder spasms  1  8/47 (17.02%) 
Hemorrhage, GU - Urinary NOS  1  7/47 (14.89%) 
Pain - Bladder  1  14/47 (29.79%) 
Urinary frequency/urgency  1  18/47 (38.30%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea (shortness of breath)  1  3/47 (6.38%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
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: Study Statistician
Organization: SWOG Statistical Center
Phone: 206-667-4623
Layout table for additonal information
Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00234039     History of Changes
Other Study ID Numbers: CDR0000446074
U10CA032102 ( U.S. NIH Grant/Contract )
S0353 ( Other Identifier: SWOG )
First Submitted: October 5, 2005
First Posted: October 6, 2005
Results First Submitted: November 19, 2012
Results First Posted: December 18, 2012
Last Update Posted: January 8, 2016