Irinotecan in Treating Patients With Stage IV or Recurrent Soft Tissue Sarcoma
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|ClinicalTrials.gov Identifier: NCT00003719|
Recruitment Status : Unknown
Verified August 2001 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : April 14, 2004
Last Update Posted : January 6, 2014
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who have stage IV or recurrent soft tissue sarcoma that has been previously treated with chemotherapy.
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma||Drug: irinotecan hydrochloride||Phase 2|
OBJECTIVES: I. Evaluate the efficacy of irinotecan in patients with metastatic, recurrent, or unresectable locally advanced previously treated soft tissue sarcoma. II. Assess the clinical and laboratory toxic effects and patient tolerance of this regimen in these patients.
OUTLINE: Patients receive irinotecan IV over 90 minutes weekly for 4 weeks, followed by 2 weeks of rest. Treatment continues every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for the first two years, then every 6 months for the next two years, and every 12 months thereafter until death.
PROJECTED ACCRUAL: A total of 14-27 patients will be accrued for this study in 18-36 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||27 participants|
|Official Title:||Phase II Evaluation of Irinotecan (CPT-11) in Previously Treated Advanced Sarcomas|
|Study Start Date :||July 1997|
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): NCT00003719
|United States, New York|
|Herbert Irving Comprehensive Cancer Center|
|New York, New York, United States, 10032|
|Study Chair:||Robert N. Taub, MD, PhD||Herbert Irving Comprehensive Cancer Center|