Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III, Phase II	Treatment	Completed	no age specified	NCI	NCCTG-825251 NCCTG-82-52-51

Objectives

I.  Compare combination chemotherapy with FAM 
(5-fluorouracil/adriamycin/mitomycin-C) with sequential use of these agents 
(mitomycin-C followed by adriamycin followed by 5-fluorouracil) in the 
treatment of advanced carcinoma of the prostate that is refractory to at least 
one hormonal therapeutic regimen and that has not previously been treated with 
chemotherapy.
II.  Develop Phase II data concerning the use of mitomycin-C as a single agent 
in patients with advanced prostatic carcinoma who have previously received no 
cytotoxic chemotherapy.
III.  Further employ the weighted scoring system as a method to define 
response to treatment in prostatic carcinoma.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with measurable or evaluable 
histologically or cytologically proven advanced carcinoma of the prostate that 
has progressed after at least one hormonal therapeutic regimen and that has 
not previously been treated with cytotoxic chemotherapeutic agents.  
Orchiectomized patients must be at least 3 weeks postoperative and have 
demonstrated clear evidence of further progression.  At least 3 weeks must 
have elapsed after any prior surgery, and healing must be sufficient to allow 
cytotoxic therapy.  Liver, kidney (creatinine no more than 0.8 mg/dl above the 
upper limit of institutional normal values is required, per Addendum 2, 
November 1985), and bone marrow function must be adequate, and the ECOG 
performance score must be 3 or better.  Patients may not have received 
radiotherapy to more than 40 percent of the bone marrow.  There may have been 
no myocardial infarction within 3 months, no angina requiring daily 
nitroglycerine and/or beta-blocking agents, no arrhythmia requiring chronic 
medication, and no congestive heart failure requiring daily digoxin.

Expected Enrollment

Up to 100 patients will be accrued on each treatment arm over 3 years.

Outline

Randomized study.
Arm I:  3-Drug Combination Chemotherapy.  FAM:  5-Fluorouracil, 5-FU, 
NSC-19893; Adriamycin, ADR, NSC-123127; Mitomycin-C, MITO, NSC-26980.
Arm II:  Sequential Single-agent Chemotherapy.  MITO; followed at progression 
by ADR; followed at progression by 5-FU.

Laurie J, Hahn RG, Therneau T, et al.: A phase II randomized trial of FAM vs sequential M-A-F in hormonally refractory advanced carcinoma of the prostate. [Abstract] Proceedings of the American Society of Clinical Oncology 6: A-399, 102, 1987.

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Richard G. Hahn, MD, Protocol chair(Contact information may not be current)		Ph: 507-284-5999