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


Phase 2
18 Years
N/A
Not Enrolling
Both
Neuroendocrine Carcinoma of the Skin

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Raymond A. Kempf, MD

Investigator Role:

Study Chair

Investigator Affiliation:

USC/Norris Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000066606

NCT ID:

NCT00003549

Start Date:

October 1998

Completion Date:

January 2003

Related Keywords:

  • Neuroendocrine Carcinoma of the Skin
  • stage II neuroendocrine carcinoma of the skin
  • stage III neuroendocrine carcinoma of the skin
  • recurrent neuroendocrine carcinoma of the skin
  • Carcinoma
  • Carcinoma, Merkel Cell
  • Carcinoma, Neuroendocrine
  • Skin Neoplasms
  • Carcinoma, Basal Cell
  • Carcinoma, Basosquamous
  • Carcinoma, Squamous Cell

Name

Location

Arizona Cancer Center Tucson, Arizona  85724
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781
USC/Norris Comprehensive Cancer Center Los Angeles, California  90033-0800
University of Colorado Cancer Center Denver, Colorado  80262
Albert B. Chandler Medical Center, University of Kentucky Lexington, Kentucky  40536-0084
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
University of Mississippi Medical Center Jackson, Mississippi  39216-4505
Barrett Cancer Center, The University Hospital Cincinnati, Ohio  45219
Cleveland Clinic Cancer Center Cleveland, Ohio  44195
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
University of California Davis Medical Center Sacramento, California  95817
CCOP - Wichita Wichita, Kansas  67214-3882
MBCCOP - LSU Medical Center New Orleans, Louisiana  70112
University of Texas Health Science Center at San Antonio San Antonio, Texas  78284-7811
CCOP - Greater Phoenix Phoenix, Arizona  85006-2726
CCOP - Atlanta Regional Atlanta, Georgia  30342-1701
CCOP - Kansas City Kansas City, Missouri  64131
UCSF Cancer Center and Cancer Research Institute San Francisco, California  94115-0128
Loyola University Medical Center Maywood, Illinois  60153
Henry Ford Hospital Detroit, Michigan  48202
Huntsman Cancer Institute Salt Lake City, Utah  84112
MBCCOP - University of South Alabama Mobile, Alabama  36688
Veterans Affairs Medical Center - Long Beach Long Beach, California  90822
Beckman Research Institute, City of Hope Los Angeles, California  91010
Veterans Affairs Outpatient Clinic - Martinez Martinez, California  94553
CCOP - Bay Area Tumor Institute Oakland, California  94609-3305
CCOP - Santa Rosa Memorial Hospital Santa Rosa, California  95403
David Grant Medical Center Travis Air Force Base, California  94535
CCOP - Central Illinois Springfield, Illinois  62526
Veterans Affairs Medical Center - Lexington Lexington, Kentucky  40511-1093
Tulane University School of Medicine New Orleans, Louisiana  70112
Veterans Affairs Medical Center - Boston (Jamaica Plain) Jamaica Plain, Massachusetts  02130
Veterans Affairs Medical Center - Ann Arbor Ann Arbor, Michigan  48105
St. Louis University Health Sciences Center Saint Louis, Missouri  63110-0250
CCOP - Cancer Research for the Ozarks Springfield, Missouri  65807
CCOP - Montana Cancer Consortium Billings, Montana  59101
CCOP - Columbus Columbus, Ohio  43206
Veterans Affairs Medical Center - Dayton Dayton, Ohio  45428
CCOP - Dayton Kettering, Ohio  45429
CCOP - Columbia River Program Portland, Oregon  97213
CCOP - Greenville Greenville, South Carolina  29615
University of Texas Medical Branch Galveston, Texas  77555-1329
Swedish Cancer Institute Seattle, Washington  98104
MBCCOP - University of New Mexico HSC Albuquerque, New Mexico  87131
CCOP - Scott and White Hospital Temple, Texas  76508
Cancer Research Center of Hawaii Honolulu, Hawaii  96813
Veterans Affairs Medical Center - Tucson Tucson, Arizona  85723
University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
Veterans Affairs Medical Center - Little Rock (McClellan) Little Rock, Arkansas  72205
Veterans Affairs Medical Center - Denver Denver, Colorado  80220
Dwight David Eisenhower Army Medical Center Fort Gordon, Georgia  30905-5650
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) Hines, Illinois  60141
University of Kansas Medical Center Kansas City, Kansas  66160-7353
Veterans Affairs Medical Center - Wichita Wichita, Kansas  67218
Louisiana State University Health Sciences Center - Shreveport Shreveport, Louisiana  71130-3932
Veterans Affairs Medical Center - Shreveport Shreveport, Louisiana  71130
Boston Medical Center Boston, Massachusetts  02118
Veterans Affairs Medical Center - Detroit Detroit, Michigan  48201-1932
Providence Hospital - Southfield Southfield, Michigan  48075-9975
Veterans Affairs Medical Center - Biloxi Biloxi, Mississippi  39531-2410
Veterans Affairs Medical Center - Jackson Jackson, Mississippi  39216
Keesler Medical Center - Keesler AFB Keesler AFB, Mississippi  39534-2576
Veterans Affairs Medical Center - Kansas City Kansas City, Missouri  64128
CCOP - St. Louis-Cape Girardeau Saint Louis, Missouri  63141
Veterans Affairs Medical Center - Albuquerque Albuquerque, New Mexico  87108-5138
Herbert Irving Comprehensive Cancer Center New York, New York  10032
Veterans Affairs Medical Center - Cincinnati Cincinnati, Ohio  45220-2288
Oklahoma Medical Research Foundation Oklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - Oklahoma City Oklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - Portland Portland, Oregon  97207
Brooke Army Medical Center Fort Sam Houston, Texas  78234-6200
Texas Tech University Health Science Center Lubbock, Texas  79415
Veterans Affairs Medical Center - San Antonio (Murphy) San Antonio, Texas  78284
Veterans Affairs Medical Center - Temple Temple, Texas  76504
Veterans Affairs Medical Center - Salt Lake City Salt Lake City, Utah  84148
CCOP - Virginia Mason Research Center Seattle, Washington  98101
Veterans Affairs Medical Center - Seattle Seattle, Washington  98108
CCOP - Northwest Tacoma, Washington  98405-0986
Veterans Affairs Medical Center - Phoenix (Hayden) Phoenix, Arizona  85012
Veterans Affairs Medical Center - New Orleans New Orleans, Louisiana  70112
CCOP - Grand Rapids Clinical Oncology Program Grand Rapids, Michigan  49503
Oregon Cancer Center at Oregon Health Sciences University Portland, Oregon  97201-3098
Veterans Affairs Medical Center - Brooklyn Brooklyn, New York  11209