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. Identifier: NCT00005874
Recruitment Status : Completed
First Posted : April 13, 2004
Last Update Posted : December 4, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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

Detailed Description:

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)
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
Actual Study Completion Date : April 2004

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00005874

United States, California
SuperGen, Incorporated
Dublin, California, United States, 94568
Sponsors and Collaborators
Astex Pharmaceuticals
Study Chair: Show-Li Sun, MD Astex Pharmaceuticals Identifier: NCT00005874     History of Changes
Other Study ID Numbers: CDR0000067910
First Posted: April 13, 2004    Key Record Dates
Last Update Posted: December 4, 2013
Last Verified: September 2001

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Intestinal Neoplasms
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Neoplasms by Site
Intestinal Diseases
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action