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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Closed under 70 NCI-78-C-56 NCI-NMOB-814

Objectives

I.  Determine response rate and duration of response among patients with 
previously untreated metastatic adenocarcinoma of the prostate to aggressive 
combination chemotherapy with adriamycin/cyclophosphamide/cis-platinum.
II.  Determine the efficacy of orchiectomy for patients who develop 
progressive disease on chemotherapy.
III.  Investigate the utility of steroid hormone receptor protein 
determinations in predicting the response of prostatic cancer to hormone 
manipulation (and perhaps to combination chemotherapy) and study whether 
combination chemotherapy alters the presence or concentration of such proteins 
in individual patients.
IV.  Study the effect of sequential chemotherapy and hormone therapy on 
various endocrinologic parameters and correlate any changes in these 
parameters with clinical response.
V.  Investigate the utility of various serial staging procedures in detecting 
objective responses of this tumor to therapy, including lymphangiography, 
pelvic CAT scans, urinary hydroxyproline excretion, CEA, and bone marrow acid 
phosphatase measurements.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with pathologically 
confirmed adenocarcinoma of the prostate who have pathologically or 
radiographically documented extrapelvic metastatic disease and who have 
received no prior chemotherapy, hormone therapy, or radiotherapy to the pelvis 
or prostatic bed.  Patients must be less than 70 years old and have a life 
expectancy of more than 2 months and a performance scale of 0-2.  There may be 
no brain metastases or spinal cord compression.  Hematologic, renal, hepatic, 
and cardiac function must be adequate.  There may be no history of another 
malignant neoplasm within 5 years prior to entry, except for nonmetastatic 
skin tumor.

Expected Enrollment

Protocol closed April 1983.

Outline

Nonrandomized study.  Enter all patients on Regimen A.  Enter patients who 
develop progressive disease on Regimen A to Regimen B.
Regimen A:  3-Drug Combination Chemotherapy.  Adriamycin, ADR, NSC-123127; 
Cyclophosphamide, CTX, NSC-26271; cis-Platinum, CACP, NSC-119875; Mannitol, 
NSC-9256; Nitrogen Mustard, NM, NSC-762, as a substitute for CTX; 
5-Fluorouracil, 5-FU, NSC-19893, as a substitute for ADR.
Regimen B:  Therapy.  Orchiectomy or Diethylstilbestrol, DES, NSC-3070.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

Samuel Broder, MD, Protocol chair		Ph: 305-590-2206; 800-327-4114