Overview

Flutamide, Suramin, and Hydrocortisone in Treating Patients With Prostate Cancer

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
Male
Summary
RATIONALE: Hormone therapy may be an effective treatment for prostate cancer. PURPOSE: Randomized phase III trial to evaluate the effectiveness of treatment with flutamide and suramin with or without hydrocortisone in men who have metastatic or recurrent prostate cancer.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Eastern Cooperative Oncology Group
Collaborators:
Cancer and Leukemia Group B
National Cancer Institute (NCI)
Southwest Oncology Group
Treatments:
Cortisol succinate
Flutamide
Goserelin
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Leuprolide
Suramin
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate that is
stage D2 Measurable or evaluable disease required with at least one of the following: At
least 7 bone lesions Visceral involvement No more than 50% replacement of liver by tumor No
clinical suspicion of brain metastases No spinal cord compression

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 (ECOG 3 allowed if
increase due only to pain) Life expectancy: At least 3 months Hematopoietic: (within 2
weeks prior to entry) WBC at least 3,000 AGC at least 1,500 Platelets at least 100,000
Hemoglobin at least 9.0 g/dL Hepatic: (within 2 weeks prior to entry) Bilirubin no greater
than 2 times normal AST and ALT no greater than 2 times normal PT and PTT normal Albumin at
least 3.0 g/dL Renal: Creatinine no greater than 2 mg/dL Creatinine clearance at least 60
mL/min BUN no greater than twice normal Cardiovascular: No myocardial infarction within 6
months No NYHA class III/IV status No history of thromboembolic or hemorrhagic
cerebrovascular accident No disseminated intravascular coagulation No anticoagulant therapy
(aspirin allowed for other uses) Other: No active bacterial infection No HIV or hepatitis B
infection No other malignancy within the past 5 years except curatively treated nonmelanoma
skin cancer or carcinoma in situ cancer of any site

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biological response modifier therapy
Chemotherapy: No prior chemotherapy (including suramin) Endocrine therapy: At least 1 year
since any adjuvant or neoadjuvant hormone therapy No more than 4 months of therapy as part
of initial prostate cancer therapy Prior finasteride for benign prostatic hypertrophy
allowed No systemic steroids other than hydrocortisone (steroid inhalers allowed)
Radiotherapy: At least 4 weeks since radiotherapy (90 days since strontium) Surgery:
Recovered from prior surgery