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Nitrocamptothecin in Treating Patients With Metastatic Melanoma

NCT ID: NCT00005875

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

1999-01-31

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 metastatic melanoma.

Detailed Description

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OBJECTIVES: I. Assess the efficacy and toxicity of nitrocamptothecin in patients with metastatic melanoma.

OUTLINE: Patients are stratified according to disease (choroidal vs nonchoroidal). Patients receive oral nitrocamptothecin daily on days 1-5. Treatment continues weekly for at least 8 weeks (2 courses) in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 28-74 patients (14-37 per stratum) will be accrued for this study.

Conditions

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Melanoma (Skin)

Keywords

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stage IV melanoma recurrent melanoma

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: Over 16 Performance status: Zubrod 0-2 Life expectancy: Greater than 8 weeks Hematopoietic: Absolute neutrophil count at least 1,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) Transaminase no greater than 3 times ULN Renal: Creatinine no greater than 2.0 mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 1 year after study No serious concurrent illness

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy and recovered Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy and recovered Surgery: Not specified
Minimum Eligible Age

16 Years

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-RFS2000-10

Identifier Type: -

Identifier Source: secondary_id

MDA-DM-98237

Identifier Type: -

Identifier Source: secondary_id

CDR0000067911

Identifier Type: -

Identifier Source: org_study_id