Phase II Study of RFS 2000 (9-Nitro-Camptothecin, 9-NC) in Patients With Soft-Tissue Sarcomas
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.
Interventional
Primary Purpose: Treatment
Show-Li Sun, MD
Study Chair
Astex Pharmaceuticals
United States: Federal Government
CDR0000067910
NCT00005874
June 1999
Name | Location |
---|---|
SuperGen, Incorporated | Dublin, California 94568 |