S9716: Combination Chemotherapy in Treating Patients With Merkel Cell Cancer
- Conditions
- Neuroendocrine Carcinoma of the Skin
- Registration Number
- NCT00003549
- Lead Sponsor
- SWOG Cancer Research Network
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (84)
MBCCOP - University of South Alabama
🇺🇸Mobile, Alabama, United States
CCOP - Greater Phoenix
🇺🇸Phoenix, Arizona, United States
Veterans Affairs Medical Center - Phoenix (Hayden)
🇺🇸Phoenix, Arizona, United States
Veterans Affairs Medical Center - Tucson
🇺🇸Tucson, Arizona, United States
Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Veterans Affairs Medical Center - Little Rock (McClellan)
🇺🇸Little Rock, Arkansas, United States
Veterans Affairs Medical Center - Long Beach
🇺🇸Long Beach, California, United States
USC/Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
Scroll for more (74 remaining)MBCCOP - University of South Alabama🇺🇸Mobile, Alabama, United States