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

2014-08-27 03:54:10 | BioPortfolio

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 unresectable or metastatic kidney cancer.

Description

OBJECTIVES:

Primary

- Determine response in patients with locally advanced unresectable or metastatic renal cell carcinoma 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 median and progression-free survival in patients treated with this regimen.

OUTLINE: Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1 and 8. Treatment repeats every 21 days for 6-8 courses in the absence of disease progression or unacceptable toxicity. Patients 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 12-36 patients will be accrued for this study within 30 months.

Study Design

Masking: Open Label, Primary Purpose: Treatment

Conditions

Kidney Cancer

Intervention

gemcitabine hydrochloride, irinotecan hydrochloride

Location

Hollings Cancer Center at Medical University of South Carolina
Charleston
South Carolina
United States
29425

Status

Active, not recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:54:10-0400

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