Bladder Cancer
Conditions
Keywords
transitional cell carcinoma of the bladder, recurrent bladder cancer, stage III bladder cancer, stage IV bladder cancer
Brief summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and irinotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving gemcitabine together with irinotecan works in treating patients with locally advanced or metastatic bladder cancer.
Detailed description
OBJECTIVES: Primary * Determine response in patients with locally advanced or metastatic transitional cell carcinoma of the bladder treated with gemcitabine and irinotecan. Secondary * Determine the duration of response in patients treated with this regimen. * Determine the tolerance to and toxicity of this regimen in these patients. * Determine the median and progression-free survival of patients treated with this regimen. OUTLINE: Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with responding disease receive 2 additional courses beyond best response. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 24 months.
Interventions
DRUGgemcitabine hydrochloride
DRUGirinotecan hydrochloride
Sponsors
Medical University of South Carolina
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed transitional cell carcinoma of the bladder * Locally advanced or metastatic disease * Unidimensionally measurable disease by physical exam or imaging study * The following are not considered measurable disease: * Bone only disease * Pleural or peritoneal effusions * CNS lesions * Irradiated lesions unless disease progression was documented after radiotherapy * Not amenable to surgery PATIENT CHARACTERISTICS: Age * Over 18 Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * Granulocyte count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin ≤ 2.0 mg/dL Renal * Creatinine ≤ 2.0 mg/dL Gastrointestinal * No active inflammatory bowel disease * No significant bowel obstruction * No chronic diarrhea Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other active malignancy except nonmelanoma skin cancer * No mental incapacitation or psychiatric illness that would preclude giving informed consent * No other severe disease that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF) Chemotherapy * No more than 1 prior platinum-based chemotherapy regimen * At least 4 weeks since prior chemotherapy * No prior irinotecan or gemcitabine * No other concurrent chemotherapy Endocrine therapy * No concurrent hormones except steroids for adrenal failure, hormones for non-disease-related conditions (e.g., insulin for diabetes), and intermittent dexamethasone as an antiemetic Radiotherapy * See Disease Characteristics * At least 4 weeks since prior radiotherapy * No concurrent palliative radiotherapy Surgery * Not specified Other * No concurrent participation in another clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response Proportion | From registration until time of complete response or partial response |
Secondary
| Measure | Time frame |
|---|---|
| Duration of Response | From registration until disease progression among patients who had at least a partial response. |
| Frequency of Adverse Events as Assessed by NCI CTC Version 2.0 | From the day of first dose until the end of study, an average of 6 months |
| Progression-free Survival | Time between registration and disease progression or death, whichever comes first. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 16 |
| Total | 16 |
Baseline characteristics
| Characteristic | Gemcitabine and Irnotecan |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 8 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Region of Enrollment United States | 16 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Response Proportion
Time frame: From registration until time of complete response or partial response
Population: Data for this endpoint was not collected
Secondary
Duration of Response
Time frame: From registration until disease progression among patients who had at least a partial response.
Population: Data for this endpoint was not collected
Secondary
Frequency of Adverse Events as Assessed by NCI CTC Version 2.0
Time frame: From the day of first dose until the end of study, an average of 6 months
Population: data for this endpoint was not collected
Secondary
Progression-free Survival
Time frame: Time between registration and disease progression or death, whichever comes first.
Population: data for this endpoint was not collected