NCT00003549

S9716: Combination Chemotherapy in Treating Patients With Merkel Cell Cancer

Official Title:

A Phase II Trial of Cyclophosphamide, Methotrexate and 5-Fluorouracil (CMF) in Neuroendocrine Carcinoma of the Skin (Merkel Cell Carcinoma)

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining cyclophosphamide, methotrexate, and fluorouracil in treating patients with Merkel cell cancer.

Eligibility

DISEASE CHARACTERISTICS: Histologically proven unresectable Merkel cell carcinoma Local-regional OR Metastatic Bidimensionally measurable disease If all known sites previously irradiated, disease must be progressive CNS metastases allowed if not only site of measurable disease No pleural effusions or ascites

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1500/mm3 Platelet count at least 100,000/mm3 Hepatic: Not specified Renal: Not specified Other: Not pregnant or nursing Fertile patients must use effective contraception No other prior malignancy within 5 years except: Adequately treated basal cell or squamous cell skin cancer Adequately treated stage I or II cancer In situ cervical cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy or immunotherapy No concurrent immunotherapy Chemotherapy: No prior chemotherapy for metastatic disease At least 4 weeks since prior adjuvant chemotherapy No prior adjuvant cyclophosphamide, methotrexate, or fluorouracil No other concurrent chemotherapy Endocrine therapy: No concurrent hormone therapy Radiotherapy: See Disease Characteristics At least 14 days since prior radiotherapy Surgery: At least 2 weeks since prior surgery

Disease(s) and\or Condition(s)

Neuroendocrine Carcinoma of the Skin

Primary Purpose
  • TREATMENT
Intervention/Treatment
    • Type: DRUG
    • Name: CMF regimen
    • Description:
    • Arm Group Labels:
    • Type: DRUG
    • Name: cyclophosphamide
    • Description:
    • Arm Group Labels:
    • Type: DRUG
    • Name: fluorouracil
    • Description:
    • Arm Group Labels:
    • Type: DRUG
    • Name: methotrexate
    • Description:
    • Arm Group Labels:
Sponsor
  • SWOG Cancer Research Network