Gemcitabine and Irinotecan in Treating Patients With Locally Advanced or Metastatic Bladder Cancer

Medical University of South Carolina (MUSC)

Status and phase

Terminated

Phase 2

Conditions

Bladder Cancer

Treatments

Drug: irinotecan hydrochloride

Drug: gemcitabine hydrochloride

Study type

Interventional

Funder types

Other

Identifiers

NCT00089128

PHARMACIA-440EONCO020298

MUSC-HR-10212

MUSC-100615

CDR0000378047

Details and patient eligibility

About

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.

Full 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.

Enrollment

16 patients

Sex

All

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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