Nitrocamptothecin in Treating Patients With Soft Tissue Sarcomas
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 nitrocamptothecin in treating patients who have locally advanced or metastatic soft tissue sarcomas.
|Gastrointestinal Stromal Tumor Sarcoma Small Intestine Cancer||Drug: rubitecan||Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Study of RFS 2000 (9-Nitro-Camptothecin, 9-NC) in Patients With Soft-Tissue Sarcomas|
|Study Start Date:||June 1999|
|Study Completion Date:||April 2004|
OBJECTIVES: I. Assess the efficacy and toxicity of nitrocamptothecin in patients with locally advanced or metastatic gastrointestinal leiomyosarcomas or other soft tissue sarcomas.
OUTLINE: Patients are stratified by disease (gastrointestinal leiomyosarcomas vs other soft tissue sarcomas). Patients receive oral nitrocamptothecin daily on days 1-5. Treatment continues weekly in the absence of disease progression or unacceptable toxicity. Responding patients who undergo surgery then receive an additional 4-6 courses (4 weeks/course).
PROJECTED ACCRUAL: A total of 34-78 patients (17-39 per stratum) will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005874
|United States, California|
|Dublin, California, United States, 94568|
|Study Chair:||Show-Li Sun, MD||Astex Pharmaceuticals|