STI571 in Treating Patients With Recurrent or Refractory Soft Tissue Sarcoma

Phase 1

Completed

• Conditions: Endometrial Cancer; Gastrointestinal Stromal Tumor; Ovarian Cancer; Sarcoma; Small Intestine Cancer

• Registration Number: NCT00006357
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary

RATIONALE: STI571 may interfere with the growth of cancer cells and may be an effective treatment for soft tissue sarcoma.

PURPOSE: Phase I/II trial to study the effectiveness of STI571 in treating patients who have recurrent or refractory soft tissue sarcoma.

Detailed Description

OBJECTIVES: I. Determine the maximum tolerated dose and associated toxicity of STI571 in patients with refractory or recurrent soft tissue sarcoma. II. Determine the pharmacokinetic profile of this treatment regimen in these patients. III. Determine the objective response and duration of response in these patients with this treatment regimen.

OUTLINE: This is a dose escalation and dose efficacy, multicenter study. In the dose efficacy portion, patients are stratified according to disease type (gastrointestinal stromal tumor vs all other soft tissue sarcomas). Phase I: Patients receive oral STI571 daily for a maximum of 24 months in the absence of disease progression or unacceptable toxicity. Cohorts of 3-8 patients receive escalating doses of STI571 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6-8 patients experience dose limiting toxicities. The recommended phase II dose is defined as the dose preceding the MTD. Phase II: Patients receive the recommended phase II dose of STI571 as in phase I. Patients are followed every 8 weeks until disease progression, and then every 16 weeks thereafter.

PROJECTED ACCRUAL: Approximately 47-72 patients (7-32 in phase I and 40 in phase II) will be accrued for this study.

Study Timeline

• Study Start: 2000-08
• Study First Submitted: 2000-10-04
• Primary Completion: 2001-04
• Study First Submitted QC: 2004-04-23
• Study First Posted: 2004-04-26
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-20
• Last Update Posted: 2012-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (16)

Herlev Hospital - University Hospital of Copenhagen; 🇩🇰 Herlev, Denmark

Aarhus Kommunehospital; 🇩🇰 Aarhus, Denmark

Universitair Ziekenhuis Antwerpen; 🇧🇪 Edegem, Belgium

U.Z. Gasthuisberg; 🇧🇪 Leuven, Belgium

Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Antoni van Leeuwenhoekhuis; 🇳🇱 Amsterdam, Netherlands

Academisch Ziekenhuis Groningen; 🇳🇱 Groningen, Netherlands

Centre Leon Berard; 🇫🇷 Lyon, France

Leiden University Medical Center; 🇳🇱 Leiden, Netherlands

University Medical Center Nijmegen; 🇳🇱 Nijmegen, Netherlands

Institut Gustave Roussy; 🇫🇷 Villejuif, France

Rotterdam Cancer Institute; 🇳🇱 Rotterdam, Netherlands

Christie Hospital N.H.S. Trust; 🇬🇧 Manchester, England, United Kingdom

Weston Park Hospital; 🇬🇧 Sheffield, England, United Kingdom

Nottingham City Hospital NHS Trust; 🇬🇧 Nottingham, England, United Kingdom

Royal Marsden NHS Trust; 🇬🇧 London, England, United Kingdom