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NCT00005875 Clinical Trial

Nitrocamptothecin in Treating Patients With Metastatic Melanoma

Melanoma (Skin) Clinical Trial

Official title:
Phase II Evaluation of RFS 2000 (9-Nitro-Camptothecin, 9NC) in Metastatic Melanoma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00005875
Other study ID # CDR0000067911
Secondary ID SUPERGEN-RFS2000
Status Completed
Phase Phase 2
First received June 2, 2000
Last updated December 3, 2013
Start date January 1999
Est. completion date April 2004

Study information
Verified date September 2001
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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 metastatic melanoma.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date April 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 16 Years and older
Eligibility DISEASE CHARACTERISTICS: Histologically or cytologically confirmed metastatic melanoma Choroidal (no prior chemotherapy required) OR Nonchoroidal No more than 3 chemotherapy regimens Bidimensionally measurable disease No symptomatic uncontrolled CNS involvement including extensive brain metastases, spinal cord compression, or meningeal carcinomatosis Not eligible for treatment protocol of higher priority

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• rubitecan

Locations
Country Name City State
United States SuperGen, Incorporated Dublin California

Sponsors (1)
Lead Sponsor Collaborator
Astex Pharmaceuticals

Country where clinical trial is conducted

United States, 

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