Gemcitabine and Irinotecan in Treating Patients With Metastatic Kidney Cancer

NCT ID: NCT00401128

Last Updated: 2017-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-05-31
• Study Completion Date: 2007-02-28

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying the side effects and how well giving gemcitabine together with irinotecan works in treating patients with metastatic kidney cancer.

Detailed Description

OBJECTIVES:

• Determine the response rate in patients with epithelial (clear or nonclear cell) renal cell carcinoma (RCC) treated with gemcitabine hydrochloride and irinotecan hydrochloride.
• Compare the response in patients with clear cell RCC vs nonclear cell RCC treated with this regimen.
• Determine the toxicities of this regimen.

OUTLINE: This is an open-label study.

Patients receive gemcitabine hydrochloride IV over 30 minutes and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Treatment repeats every 21 days for at least 6 courses in the absence of unacceptable toxicity or disease progression.

After completion of study treatment, patients are followed every 3 months for 1 year.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Conditions

Kidney Cancer

Study Design

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

Interventions

gemcitabine hydrochloride

Intervention Type: DRUG

irinotecan hydrochloride

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed epithelial renal cell carcinoma (RCC), including either clear cell or nonclear cell RCC
• Strong clinical evidence or biopsy proof of metastases to a site or sites distant from the primary tumor
• Measurable disease
• No untreated or progressive CNS metastases

PATIENT CHARACTERISTICS:

• ECOG performance status 0-1
• Life expectancy > 3 months
• Absolute neutrophil count > 1,500/mm³
• Platelet count > 100,000/mm³
• Hemoglobin > 9.5 g/dL
• Creatinine ≤ 1.8 mg/dL
• Bilirubin < 1.5 mg/dL
• Calcium < 11.5 mg/dL
• ALT and AST < 3 times upper limit of normal
• No history of any of the following:

• Serious cardiac arrhythmia or cardiac arrhythmia requiring treatment
• Congestive heart failure
• Angina pectoris
• Other severe cardiovascular disease producing limitations of physical activity (i.e., New York Heart Association class III-IV heart disease)
• No other prior malignancy except for the following:

• Basal cell or squamous cell carcinoma of the skin
• Carcinoma in situ of the uterine cervix
• Any malignancy treated with curative intent and in complete remission for > 3 years
• No active peptic ulcer disease, inflammatory bowel disease, or chronic diarrhea
• No local or systemic infections requiring IV antibiotics within the past 28 days
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

• Recovered from prior hormonal therapy, radiotherapy, biologic therapy, or chemotherapy
• No more than 3 prior therapeutic regimens for metastatic disease
• No prior organ allograft
• More than 28 days since prior major surgery requiring general anesthesia
• More than 28 days since prior radiotherapy to control pain from skeletal lesions
• More than 28 days since prior hormonal treatment

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

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ronald M. Bukowski, MD

Role: STUDY_CHAIR

The Cleveland Clinic

Locations

Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

P30CA043703

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CASE-CCF-6695

Identifier Type: -

Identifier Source: secondary_id

CASE-CCF-6695

Identifier Type: -

Identifier Source: org_study_id