Combination Chemotherapy in Treating Patients With Metastatic Kidney Cancer

Phase 2

Completed

• Conditions: Kidney Cancer

• Registration Number: NCT00003683
• Lead Sponsor: UNICANCER

Brief 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.

Study Timeline

• Study Start: 1998-03
• Study First Submitted: 1999-11-01
• Primary Completion: 2000-11-05
• Study Completion: 2002-04
• Study First Submitted QC: 2004-01-26
• Study First Posted: 2004-01-27
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-18
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (14)

Institut Sainte Catherine; 🇫🇷 Avignon, France

CRLCC Nantes - Atlantique; 🇫🇷 Nantes-Saint Herblain, France

C.H.U. - Hopital Gaston Doumergue; 🇫🇷 Nimes, France

Centre Eugene Marquis; 🇫🇷 Rennes, France

Centre Rene Huguenin; 🇫🇷 Saint Cloud, France

Institut J. Paoli and I. Calmettes; 🇫🇷 Marseille, France

Centre Antoine Lacassagne; 🇫🇷 Nice, France

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle; 🇫🇷 Montpellier, France

Centre Leon Berard; 🇫🇷 Lyon, France

Hotel Dieu de Paris; 🇫🇷 Paris, France

Institut Curie - Section Medicale; 🇫🇷 Paris, France

Institut Jean Godinot; 🇫🇷 Reims, France

Centre Hospitalier General de Saint Nazaire; 🇫🇷 Saint Nazaire, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France