Overview

S9716: Combination Chemotherapy in Treating Patients With Merkel Cell Cancer

Status:
Completed
Trial end date:
2003-01-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Southwest Oncology Group
Collaborator:
National Cancer Institute (NCI)
Treatments:
Cyclophosphamide
Fluorouracil
Methotrexate
Criteria
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