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Sponsored by: |
SuperGen |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005874 |
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 | Intervention | Phase |
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Gastrointestinal Stromal Tumor Sarcoma Small Intestine Cancer |
Drug: rubitecan |
Phase II |
Study Type: | Interventional |
Study Design: | 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 |
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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically confirmed locally advanced or metastatic inoperable soft tissue sarcoma Measurable or evaluable disease that has not been irradiated Must have received, refused, or be not eligible for doxorubicin/ifosfamide treatment Previously untreated gastrointestinal leiomyosarcoma allowed
PATIENT CHARACTERISTICS: Age: Not specified Performance status: Zubrod 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Transaminases no greater than 3 times normal Renal: Creatinine less than 2.0 mg/dL Cardiovascular: No New York Heart Association class III or IV heart disease No active coronary disease requiring therapy Pulmonary: No severe pulmonary insufficiency Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study No other prior malignancy in past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix No concurrent active infections No psychosis or mental disability that would preclude study
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 7 days since prior biological therapy and recovered No concurrent immunotherapy Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy and recovered No other concurrent chemotherapy Endocrine therapy: At least 7 days since prior hormonal therapy and recovered Radiotherapy: See Disease Characteristics Surgery: Not specified
Study ID Numbers: | CDR0000067910, SUPERGEN-RFS2000-24, MDA-DM-99109 |
Study First Received: | June 2, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00005874 History of Changes |
Health Authority: | United States: Federal Government |
adult leiomyosarcoma stage III adult soft tissue sarcoma recurrent adult soft tissue sarcoma small intestine leiomyosarcoma metastatic childhood soft tissue sarcoma |
recurrent childhood soft tissue sarcoma childhood leiomyosarcoma gastrointestinal stromal tumor stage IV adult soft tissue sarcoma |
Jejunal Neoplasms Digestive System Neoplasms Leiomyosarcoma Gastrointestinal Diseases 9-nitrocamptothecin Intestinal Diseases Ileal Diseases Camptothecin Recurrence Intestinal Neoplasms |
Duodenal Neoplasms Neoplasms, Connective and Soft Tissue Soft Tissue Sarcomas Malignant Mesenchymal Tumor Digestive System Diseases Ileal Neoplasms Sarcoma Gastrointestinal Neoplasms Gastrointestinal Stromal Tumors Duodenal Diseases |
Jejunal Neoplasms Neoplasms by Histologic Type Digestive System Neoplasms Gastrointestinal Diseases Intestinal Diseases Ileal Diseases Intestinal Neoplasms Duodenal Neoplasms Neoplasms, Connective and Soft Tissue |
Neoplasms Neoplasms by Site Digestive System Diseases Ileal Neoplasms Jejunal Diseases Sarcoma Gastrointestinal Neoplasms Gastrointestinal Stromal Tumors Duodenal Diseases |