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Search / Trial NCT00003549

S9716: Combination Chemotherapy in Treating Patients With Merkel Cell Cancer

Launched by SWOG CANCER RESEARCH NETWORK · Jun 23, 2004

Trial Information

Current as of May 28, 2025

Completed

Keywords

Stage Ii Neuroendocrine Carcinoma Of The Skin Stage Iii Neuroendocrine Carcinoma Of The Skin Recurrent Neuroendocrine Carcinoma Of The Skin

ClinConnect Summary

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 diseas...

Gender

ALL

Eligibility 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

About Swog Cancer Research Network

The SWOG Cancer Research Network is a leading cancer clinical trial organization dedicated to improving cancer treatment and outcomes through innovative research. Comprising a collaborative network of academic institutions, community hospitals, and cancer centers, SWOG conducts rigorous clinical trials that advance the understanding of cancer biology, prevention, and therapy. With a strong emphasis on inclusivity and diversity, SWOG aims to ensure that clinical research reflects the populations affected by cancer, ultimately striving to enhance patient care and quality of life. Through its commitment to scientific excellence and collaboration, SWOG plays a pivotal role in shaping the future of oncology.

Locations

Oklahoma City, Oklahoma, United States

Tucson, Arizona, United States

Ann Arbor, Michigan, United States

Los Angeles, California, United States

Los Angeles, California, United States

Denver, Colorado, United States

Lexington, Kentucky, United States

Detroit, Michigan, United States

Jackson, Mississippi, United States

Cincinnati, Ohio, United States

Cleveland, Ohio, United States

Spartanburg, South Carolina, United States

Sacramento, California, United States

Wichita, Kansas, United States

New Orleans, Louisiana, United States

Phoenix, Arizona, United States

Atlanta, Georgia, United States

Kansas City, Missouri, United States

San Francisco, California, United States

Maywood, Illinois, United States

Mobile, Alabama, United States

Long Beach, California, United States

Los Angeles, California, United States

Martinez, California, United States

Oakland, California, United States

Santa Rosa, California, United States

Travis Air Force Base, California, United States

Lexington, Kentucky, United States

New Orleans, Louisiana, United States

Jamaica Plain, Massachusetts, United States

Ann Arbor, Michigan, United States

Detroit, Michigan, United States

Saint Louis, Missouri, United States

Springfield, Missouri, United States

Billings, Montana, United States

Columbus, Ohio, United States

Dayton, Ohio, United States

Kettering, Ohio, United States

Portland, Oregon, United States

Greenville, South Carolina, United States

Galveston, Texas, United States

Seattle, Washington, United States

Albuquerque, New Mexico, United States

Temple, Texas, United States

Honolulu, Hawaii, United States

Tucson, Arizona, United States

Little Rock, Arkansas, United States

Little Rock, Arkansas, United States

Denver, Colorado, United States

Fort Gordon, Georgia, United States

Decatur, Illinois, United States

Hines, Illinois, United States

Wichita, Kansas, United States

Shreveport, Louisiana, United States

Shreveport, Louisiana, United States

Boston, Massachusetts, United States

Detroit, Michigan, United States

Southfield, Michigan, United States

Biloxi, Mississippi, United States

Jackson, Mississippi, United States

Kansas City, Missouri, United States

Saint Louis, Missouri, United States

Albuquerque, New Mexico, United States

New York, New York, United States

Cincinnati, Ohio, United States

Oklahoma City, Oklahoma, United States

Portland, Oregon, United States

San Antonio, Texas, United States

Temple, Texas, United States

Salt Lake City, Utah, United States

Seattle, Washington, United States

Seattle, Washington, United States

Tacoma, Washington, United States

Phoenix, Arizona, United States

Kansas City, Kansas, United States

New Orleans, Louisiana, United States

Grand Rapids, Michigan, United States

Keesler Afb, Mississippi, United States

Portland, Oregon, United States

Fort Sam Houston, Texas, United States

Lubbock, Texas, United States

Salt Lake City, Utah, United States

San Antonio, Texas, United States

Brooklyn, New York, United States

Patients applied

0 patients applied

Trial Officials

Raymond A. Kempf, MD

Study Chair

University of Southern California

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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