Nitrocamptothecin in Treating Patients With Soft Tissue Sarcomas
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00005874|
Recruitment Status : Completed
First Posted : April 13, 2004
Last Update Posted : December 4, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Gastrointestinal Stromal Tumor Sarcoma Small Intestine Cancer||Drug: rubitecan||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|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|
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): NCT00005874
|United States, California|
|Dublin, California, United States, 94568|
|Study Chair:||Show-Li Sun, MD||Astex Pharmaceuticals|