S9716: Combination Chemotherapy in Treating Patients With Merkel Cell Cancer
|ClinicalTrials.gov Identifier: NCT00003549|
Recruitment Status : Completed
First Posted : June 24, 2004
Last Update Posted : October 8, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Neuroendocrine Carcinoma of the Skin||Drug: CMF regimen Drug: cyclophosphamide Drug: fluorouracil Drug: methotrexate||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Cyclophosphamide, Methotrexate and 5-Fluorouracil (CMF) in Neuroendocrine Carcinoma of the Skin (Merkel Cell Carcinoma)|
|Study Start Date :||October 1998|
|Actual Primary Completion Date :||September 2001|
|Actual Study Completion Date :||January 2003|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003549
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|Study Chair:||Raymond A. Kempf, MD||University of Southern California|