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Nitrocamptothecin in Treating Patients With Soft Tissue Sarcomas

NCT ID: NCT00005874

Last Updated: 2013-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

1999-06-30

Study Completion Date

2004-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Gastrointestinal Stromal Tumor Sarcoma Small Intestine Cancer

Keywords

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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

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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rubitecan

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astex Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Principal Investigators

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Show-Li Sun, MD

Role: STUDY_CHAIR

Astex Pharmaceuticals, Inc.

Locations

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SuperGen, Incorporated

Dublin, California, United States

Site Status

Countries

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United States

Other Identifiers

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SUPERGEN-RFS2000-24

Identifier Type: -

Identifier Source: secondary_id

MDA-DM-99109

Identifier Type: -

Identifier Source: secondary_id

CDR0000067910

Identifier Type: -

Identifier Source: org_study_id