Trial Outcomes & Findings for S0353, Gemcitabine in Treating Patients With Recurrent Bladder Cancer That Has Not Responded to Previous Bacillus Calmette-Guerin (NCT NCT00234039)

NCT ID: NCT00234039

Last Updated: 2016-01-08

Results Overview

Complete Response is defined as negative cystoscopy with negative biopsy and no evidence of cancer on urine cytology at the Week 8 - 12 cystoscopy

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 58 participants
• Primary outcome timeframe: Week 8-12, then every 3 months for the first 2 years, and then every 6 months for the years 3-5
• Results posted on: 2016-01-08

Participant Flow

Participant milestones

Measure	Intravesical Gemcitabine 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 Study STARTED	58
Overall Study Eligible	49
Overall Study Eligible and Began Protocol Therapy	47
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	50

Reasons for withdrawal

Measure	Intravesical Gemcitabine 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 Study Adverse Event	2
Overall Study Progression/relapse	34
Overall Study Other - Not Protocol Specified	3
Overall Study Ineligible	9
Overall Study No Protocol Treatment Received	2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Intravesical Gemcitabine n=47 Participants 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.
Age, Continuous	70 years n=93 Participants
Sex: Female, Male Female	14 Participants n=93 Participants
Sex: Female, Male Male	33 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	45 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	3 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	43 Participants n=93 Participants
Race (NIH/OMB) More than one race	1 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants

PRIMARY outcome

Timeframe: Week 8-12, then every 3 months for the first 2 years, and then every 6 months for the years 3-5

Population: All eligible patients who started treatment were included in the analysis

Complete Response is defined as negative cystoscopy with negative biopsy and no evidence of cancer on urine cytology at the Week 8 - 12 cystoscopy

Outcome measures

Measure	Intravesical Gemcitabine n=47 Participants 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.
Complete Response Rate at the End of Induction	46 percentage of participants Interval 30.0 to 60.0

SECONDARY outcome

Timeframe: 1 year

Population: All eligible patients who started treatment were included in the analysis

Measured from the day of registration to death due to any cause. Survival is censored at date of last contact.

Outcome measures

Measure	Intravesical Gemcitabine n=47 Participants 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 Survival (OS)	98 percentage of participants

SECONDARY outcome

Timeframe: 1 year

Population: All eligible patients who started treatment were included in the analysis

Recurrence-free Survival is defined as time from registration to first instance of disease recurrence, or death due to any cause.

Outcome measures

Measure	Intravesical Gemcitabine n=47 Participants 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.
Recurrence-free Survival (RFS)	28 percentage of participants Interval 16.0 to 43.0

SECONDARY outcome

Timeframe: Patients were assessed for adverse events weekly for 6 weeks and then every 4 weeks for 40 weeks

Population: 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.

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.

Outcome measures

Measure	Intravesical Gemcitabine n=47 Participants 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.
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Neutrophils/granulocytes (ANC/AGC)	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Pain - Bladder	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Urinary frequency/urgency	2 Participants

Adverse Events

Intravesical Gemcitabine

Serious events: 0 serious events

Other events: 32 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Intravesical Gemcitabine n=47 participants at risk 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.
Blood and lymphatic system disorders Hemoglobin	6.4% 3/47 • Patients were assessed for adverse events weekly for 6 weeks and then every 4 weeks for 40 weeks
Gastrointestinal disorders Constipation	6.4% 3/47 • Patients were assessed for adverse events weekly for 6 weeks and then every 4 weeks for 40 weeks
Gastrointestinal disorders Nausea	8.5% 4/47 • Patients were assessed for adverse events weekly for 6 weeks and then every 4 weeks for 40 weeks
General disorders Fatigue (asthenia, lethargy, malaise)	19.1% 9/47 • Patients were assessed for adverse events weekly for 6 weeks and then every 4 weeks for 40 weeks
General disorders Pain-Other (Specify)	6.4% 3/47 • Patients were assessed for adverse events weekly for 6 weeks and then every 4 weeks for 40 weeks
Investigations Platelets	6.4% 3/47 • Patients were assessed for adverse events weekly for 6 weeks and then every 4 weeks for 40 weeks
Nervous system disorders Dizziness	6.4% 3/47 • Patients were assessed for adverse events weekly for 6 weeks and then every 4 weeks for 40 weeks
Renal and urinary disorders Bladder spasms	17.0% 8/47 • Patients were assessed for adverse events weekly for 6 weeks and then every 4 weeks for 40 weeks
Renal and urinary disorders Hemorrhage, GU - Urinary NOS	14.9% 7/47 • Patients were assessed for adverse events weekly for 6 weeks and then every 4 weeks for 40 weeks
Renal and urinary disorders Pain - Bladder	29.8% 14/47 • Patients were assessed for adverse events weekly for 6 weeks and then every 4 weeks for 40 weeks
Renal and urinary disorders Urinary frequency/urgency	38.3% 18/47 • Patients were assessed for adverse events weekly for 6 weeks and then every 4 weeks for 40 weeks
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	6.4% 3/47 • Patients were assessed for adverse events weekly for 6 weeks and then every 4 weeks for 40 weeks

Additional Information

Study Statistician

SWOG Statistical Center

Phone: 206-667-4623

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place