Gemcitabine and Irinotecan in Treating Patients With Metastatic Kidney Cancer

Kidney Cancer Clinical Trial

Official title:

Phase II Study of Gemcitabine Plus Irinotecan in Patients With Metastatic Renal Cell Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00401128
• Other study ID #: CASE-CCF-6695
• Secondary ID: P30CA043703CASE-
• Status: Completed
• Phase: Phase 2
• First received: November 16, 2006
• Last updated: April 18, 2017
• Start date: May 2004
• Est. completion date: February 2007

Study information

• Verified date: April 2017
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: February 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms

Intervention

Drug:
• gemcitabine hydrochloride

• irinotecan hydrochloride

Locations

Country	Name	City	State
United States	Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response
Primary	Safety and efficacy
Secondary	Difference in response to therapy in patients with clear vs nonclear cell renal cell carcinoma