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

This study has been completed.
Sponsor:
Collaborators:
Cancer and Leukemia Group B
Southwest Oncology Group
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00002881
First received: November 1, 1999
Last updated: November 6, 2010
Last verified: May 2007
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: flutamide
Drug: goserelin acetate
Drug: leuprolide acetate
Drug: suramin
Drug: therapeutic hydrocortisone
Procedure: orchiectomy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: PHASE III TRIAL OF ORCHIECTOMY/LHRH ANALOG + FLUTAMIDE + SURAMIN + HYDROCORTISONE VS ORCHIECTOMY/LHRH ANALOG + FLUTAMIDE IN PATIENTS WITH METASTATIC PROSTATE CANCER

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: October 1996
Primary Completion Date: April 1998 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES: I. Compare time to progression and survival in patients with metastatic or recurrent adenocarcinoma of the prostate treated with orchiectomy or LHRH analogue (i.e. leuprolide or goserelin) plus flutamide with vs. without suramin and hydrocortisone. II. Compare these two treatments with respect to qualitative and quantitative toxic effects. III. Evaluate normalization of prostatic-specific antigen (PSA), duration of PSA response, and the use of PSA as a surrogate marker of tumor response in these patients. IV. Compare these two treatments with respect to quality of life and pain status.

OUTLINE: This is a randomized study. Patients are stratified by their choice of androgen suppression technique and by participating institution. Within 3 days after randomization, all patients receive daily flutamide. On day 4, patients undergo orchiectomy or begin monthly LHRH analogue therapy with leuprolide or goserelin. Patients randomized to receive suramin begin a 12-week course 8-25 days after orchiectomy/LHRH therapy. Hydrocortisone replacement therapy begins concomitantly with suramin and continues for at least 3 months after the completion of suramin treatment or until disease progression intervenes. Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 800-1,000 patients will be entered within 3.25 to 4.25 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002881

Locations
United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307-5000
Sponsors and Collaborators
Eastern Cooperative Oncology Group
Cancer and Leukemia Group B
Southwest Oncology Group
Investigators
Study Chair: George Wilding, MD University of Wisconsin, Madison
Study Chair: Nancy A. Dawson, MD Walter Reed Army Medical Center
Study Chair: A. O. Sartor, MD Louisiana State University Health Sciences Center in New Orleans
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00002881     History of Changes
Other Study ID Numbers: CDR0000065185, E-8892, CLB-E8892, SWOG-E8892
Study First Received: November 1, 1999
Last Updated: November 6, 2010
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate
stage IV prostate cancer
recurrent prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Leuprolide
Goserelin
Flutamide
Suramin
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Cortisol succinate
Hydrocortisone
Hydrocortisone-17-butyrate
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anti-Inflammatory Agents
Dermatologic Agents
Antinematodal Agents
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on October 01, 2014