Chemotherapy in Treating Patients With Advanced Sarcoma

Phase 2

Completed

• Conditions: Ovarian Cancer; Sarcoma

• Registration Number: NCT00002526
• Lead Sponsor: Swiss Group for Clinical Cancer Research

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 drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of ifosfamide and doxorubicin in patients with advanced sarcoma.

Detailed Description

OBJECTIVES: I. Determine the response rate, time to treatment failure, and survival in patients with advanced soft tissue or gynecological sarcoma treated with high-dose ifosfamide and doxorubicin.

OUTLINE: Patients receive ifosfamide IV continuously on days 1-5 and doxorubicin IV on days 1-3. Filgrastim (G-CSF) is administered subcutaneously daily beginning 24 hours after completion of ifosfamide infusion and continuing through day 16 (or until day 20 if blood counts have not recovered by day 16). Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed at treatment failure and then annually thereafter.

PROJECTED ACCRUAL: A total of 16-46 patients will be accrued for this study.

Study Timeline

• Study Start: 1993-01
• Primary Completion: 1995-09
• Study Completion: 1995-09
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2004-03-10
• Study First Posted: 2004-03-11
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-14
• Last Update Posted: 2012-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (1)

Centre Hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, Switzerland