STI571 in Treating Patients With Recurrent or Refractory Soft Tissue Sarcoma
|ClinicalTrials.gov Identifier: NCT00006357|
Recruitment Status : Completed
First Posted : April 26, 2004
Last Update Posted : September 24, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Cancer Gastrointestinal Stromal Tumor Ovarian Cancer Sarcoma Small Intestine Cancer||Drug: imatinib mesylate||Phase 1 Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||91 participants|
|Official Title:||Dose Finding and Phase II Study of STI 571 in Advanced Soft Tissue Sarcoma|
|Study Start Date :||August 2000|
|Actual Primary Completion Date :||April 2001|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006357
|Universitair Ziekenhuis Antwerpen|
|Edegem, Belgium, B-2650|
|Leuven, Belgium, B-3000|
|Aarhus, Denmark, DK-8000|
|Copenhagen, Denmark, 2100|
|Herlev Hospital - University Hospital of Copenhagen|
|Herlev, Denmark, DK-2730|
|Centre Leon Berard|
|Lyon, France, 69373|
|Institut Gustave Roussy|
|Villejuif, France, F-94805|
|Antoni van Leeuwenhoekhuis|
|Amsterdam, Netherlands, 1066 CX|
|Academisch Ziekenhuis Groningen|
|Groningen, Netherlands, 9713 EZ|
|Leiden University Medical Center|
|Leiden, Netherlands, 2300 CA|
|University Medical Center Nijmegen|
|Nijmegen, Netherlands, NL-6252 HB|
|Rotterdam Cancer Institute|
|Rotterdam, Netherlands, 3075 EA|
|Royal Marsden NHS Trust|
|London, England, United Kingdom, SW3 6JJ|
|Christie Hospital N.H.S. Trust|
|Manchester, England, United Kingdom, M20 4BX|
|Nottingham City Hospital NHS Trust|
|Nottingham, England, United Kingdom, NG5 1PB|
|Weston Park Hospital|
|Sheffield, England, United Kingdom, S1O 2SJ|
|Study Chair:||Jacob Verweij, MD, PhD||Daniel Den Hoed Cancer Center at Erasmus Medical Center|