Trial Outcomes & Findings for Gemcitabine and Irinotecan in Treating Patients With Locally Advanced or Metastatic Bladder Cancer (NCT NCT00089128)
NCT ID: NCT00089128
Last Updated: 2018-07-12
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
From registration until time of complete response or partial response
Results posted on
2018-07-12
Participant Flow
Participant milestones
| Measure |
Gemcitabine and Irnotecan
On day 1 and day 8 of each 21 day cycle:
gemcitabine hydrochloride 1,000 mg/m2 IV over 30 minutes
irinotecan hydrochloride 100mg/m2 IV over 90 minutes
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gemcitabine and Irinotecan in Treating Patients With Locally Advanced or Metastatic Bladder Cancer
Baseline characteristics by cohort
| Measure |
Gemcitabine and Irnotecan
n=16 Participants
On day 1 and day 8 of each 21 day cycle:
gemcitabine hydrochloride 1,000 mg/m2 IV over 30 minutes
irinotecan hydrochloride 100mg/m2 IV over 90 minutes
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
2 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: From registration until time of complete response or partial responsePopulation: Data for this endpoint was not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From registration until disease progression among patients who had at least a partial response.Population: Data for this endpoint was not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the day of first dose until the end of study, an average of 6 monthsPopulation: data for this endpoint was not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Time between registration and disease progression or death, whichever comes first.Population: data for this endpoint was not collected
Outcome measures
Outcome data not reported
Adverse Events
Gemcitabine and Irnotecan
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place