Know Cancer

forgot password

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

Phase 2
16 Years
Not Enrolling
Melanoma (Skin)

Thank you

Trial Information

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

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

Inclusion Criteria

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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Show-Li Sun, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Astex Pharmaceuticals


United States: Federal Government

Study ID:




Start Date:

January 1999

Completion Date:

Related Keywords:

  • Melanoma (Skin)
  • stage IV melanoma
  • recurrent melanoma
  • Melanoma



SuperGen, Incorporated Dublin, California  94568