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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
flutamide
goserelin acetate
leuprolide acetate
suramin
therapeutic hydrocortisone
orchiectomy
Sponsored by
Eastern Cooperative Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Walter Reed Army Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
November 6, 2010
Sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI), Cancer and Leukemia Group B, SWOG Cancer Research Network
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1. Study Identification

Unique Protocol Identification Number
NCT00002881
Brief Title
Flutamide, Suramin, and Hydrocortisone in Treating Patients With Prostate Cancer
Official Title
PHASE III TRIAL OF ORCHIECTOMY/LHRH ANALOG + FLUTAMIDE + SURAMIN + HYDROCORTISONE VS ORCHIECTOMY/LHRH ANALOG + FLUTAMIDE IN PATIENTS WITH METASTATIC PROSTATE CANCER
Study Type
Interventional

2. Study Status

Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
October 1996 (undefined)
Primary Completion Date
April 1998 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI), Cancer and Leukemia Group B, SWOG Cancer Research Network

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
flutamide
Intervention Type
Drug
Intervention Name(s)
goserelin acetate
Intervention Type
Drug
Intervention Name(s)
leuprolide acetate
Intervention Type
Drug
Intervention Name(s)
suramin
Intervention Type
Drug
Intervention Name(s)
therapeutic hydrocortisone
Intervention Type
Procedure
Intervention Name(s)
orchiectomy

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Wilding, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Nancy A. Dawson, MD
Organizational Affiliation
Walter Reed Army Medical Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
A. O. Sartor, MD
Organizational Affiliation
Louisiana State University Health Sciences Center in New Orleans
Official's Role
Study Chair
Facility Information:
Facility Name
Walter Reed Army Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20307-5000
Country
United States

12. IPD Sharing Statement

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

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