NCT00003683

Combination Chemotherapy in Treating Patients With Metastatic Kidney Cancer

Treatment of Sarcomatous Kidney Cancer That is Metastatic in Adults With Doxorubicin and Ifosfamide. Phase II Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: UNICANCER · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining doxorubicin and ifosfamide in treating patients who have metastatic kidney cancer.

Detailed description

OBJECTIVES: I. Determine the efficacy in terms of objective response after treatment with ifosfamide and doxorubicin in patients with metastatic sarcomatoid renal cell cancer. II. Determine the toxicity of this regimen in these patients. III. Determine the effect of this regimen on the survival of these patients. OUTLINE: This is a multicenter study. Patients receive doxorubicin IV on day 1 and ifosfamide IV over 2 hours on days 1 and 2. Treatment is repeated every 3 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 3 years.

Conditions

• Kidney Cancer

Interventions

Type	Name	Description
DRUG	doxorubicin hydrochloride
DRUG	ifosfamide

Timeline

• Start date: 1998-03-01
• Primary completion: 2000-11-05
• Completion: 2002-04-01
• First posted: 2004-01-27
• Last updated: 2021-02-21

Locations

14 sites across 1 country: France