NCT00003549

S9716: Combination Chemotherapy in Treating Patients With Merkel Cell Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

OBJECTIVES: I. Investigate the ability of the Southwest Oncology Group Melanoma Committee to enroll patients with unresectable Merkel cell carcinoma that is local-regional or metastatic. II. Determine the overall survival rate and objective response rate of these patients after treatment with cyclophosphamide, methotrexate, and fluorouracil. OUTLINE: Patients are stratified according to local-regional disease versus metastatic disease. Patients receive cyclophosphamide IV, methotrexate IV, and fluorouracil IV on day 1. Courses repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicities. Patients are followed every 6 months for 2 years, then annually thereafter. PROJECTED ACCRUAL: A total of 80 patients (40 patients per stratum) will be accrued for this study.

Conditions

• Neuroendocrine Carcinoma of the Skin

Interventions

Type	Name	Description
DRUG	CMF regimen
DRUG	cyclophosphamide
DRUG	fluorouracil
DRUG	methotrexate

Timeline

• Start date: 1998-10-01
• Primary completion: 2001-09-01
• Completion: 2003-01-01
• First posted: 2004-06-24
• Last updated: 2012-10-08

Locations

84 sites across 1 country: United States