S9716: Combination Chemotherapy in Treating Patients With Merkel Cell Cancer
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Neuroendocrine Carcinoma of the Skin |
Drug: CMF regimen Drug: cyclophosphamide Drug: fluorouracil Drug: methotrexate |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Trial of Cyclophosphamide, Methotrexate and 5-Fluorouracil (CMF) in Neuroendocrine Carcinoma of the Skin (Merkel Cell Carcinoma) |
| Enrollment: | 80 |
| Study Start Date: | October 1998 |
| Study Completion Date: | January 2003 |
| Primary Completion Date: | September 2001 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Show 84 Study Locations| Study Chair: | Raymond A. Kempf, MD | USC/Norris Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Southwest Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00003549 History of Changes |
| Other Study ID Numbers: | CDR0000066606, U10CA032102, S9716 |
| Study First Received: | November 1, 1999 |
| Last Updated: | October 5, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Southwest Oncology Group:
|
stage II neuroendocrine carcinoma of the skin stage III neuroendocrine carcinoma of the skin recurrent neuroendocrine carcinoma of the skin |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Merkel Cell Carcinoma, Neuroendocrine Skin Neoplasms Carcinoma, Basal Cell Carcinoma, Basosquamous Carcinoma, Squamous Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Adenocarcinoma Neoplasms, Nerve Tissue |
Neoplasms by Site Skin Diseases Neoplasms, Basal Cell Neoplasms, Squamous Cell Cyclophosphamide Fluorouracil Methotrexate Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents |
ClinicalTrials.gov processed this record on May 22, 2013