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Nitrocamptothecin in Treating Patients With Soft Tissue Sarcomas

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ClinicalTrials.gov Identifier: NCT00005874
Recruitment Status : Completed
First Posted : April 13, 2004
Last Update Posted : December 4, 2013
Information provided by:

June 2, 2000
April 13, 2004
December 4, 2013
June 1999
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Complete list of historical versions of study NCT00005874 on ClinicalTrials.gov Archive Site
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Nitrocamptothecin in Treating Patients With Soft Tissue Sarcomas
Phase II Study of RFS 2000 (9-Nitro-Camptothecin, 9-NC) in 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.

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.

Phase 2
Primary Purpose: Treatment
  • Gastrointestinal Stromal Tumor
  • Sarcoma
  • Small Intestine Cancer
Drug: rubitecan
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
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April 2004
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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

Sexes Eligible for Study: All
Child, Adult, Senior
Contact information is only displayed when the study is recruiting subjects
United States
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Astex Pharmaceuticals
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Study Chair: Show-Li Sun, MD Astex Pharmaceuticals
National Cancer Institute (NCI)
September 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP