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

NCT ID: NCT00089128

Last Updated: 2018-07-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-11-30
• Study Completion Date: 2008-11-30

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.

Conditions

Bladder Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Gemcitabine and Irnotecan

Group Type: EXPERIMENTAL

gemcitabine hydrochloride

Intervention Type: DRUG

irinotecan hydrochloride

Intervention Type: DRUG

Interventions

gemcitabine hydrochloride

Intervention Type: DRUG

irinotecan hydrochloride

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Uzair B. Chaudhary, MD

Role: STUDY_CHAIR

Medical University of South Carolina

Gustavo Leone

Role: STUDY_CHAIR

Medical University of South Carolina, Hollings Cancer Center

Locations

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Other Identifiers

MUSC-100615

Identifier Type: -

Identifier Source: secondary_id

PHARMACIA-440EONCO020298

Identifier Type: -

Identifier Source: secondary_id

MUSC-HR-10212

Identifier Type: -

Identifier Source: secondary_id

CDR0000378047

Identifier Type: -

Identifier Source: org_study_id