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

Prostate Cancer Clinical Trial

Official title:

PHASE III TRIAL OF ORCHIECTOMY/LHRH ANALOG + FLUTAMIDE + SURAMIN + HYDROCORTISONE VS ORCHIECTOMY/LHRH ANALOG + FLUTAMIDE IN PATIENTS WITH METASTATIC PROSTATE CANCER

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002881
• Other study ID #: CDR0000065185
• Secondary ID: E-8892CLB-E8892S
• Status: Completed
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: November 6, 2010
• Start date: October 1996

Study information

• Verified date: May 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: April 1998
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• flutamide

• goserelin acetate

• leuprolide acetate

• suramin

• therapeutic hydrocortisone

Procedure:
• orchiectomy

Locations

Country	Name	City	State
United States	Walter Reed Army Medical Center	Washington	District of Columbia

Sponsors (4)

Lead Sponsor	Collaborator
Eastern Cooperative Oncology Group	Cancer and Leukemia Group B, National Cancer Institute (NCI), Southwest Oncology Group

Country where clinical trial is conducted

United States,