Prostate Cancer Clinical Trial

Low, Intermediate, or High Dose Suramin in Treating Patients With Hormone-Refractory Prostate Cancer

Summary

Randomized phase III trial to compare the effectiveness of low, intermediate, and high dose suramin in treating men with stage IV prostate cancer that is refractory to hormone therapy. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of suramin is more effective for prostate cancer.

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Full Description

OBJECTIVES:

I. Compare the response in patients with advanced hormone-refractory adenocarcinoma of the prostate treated with low- vs intermediate- vs high-dose suramin.

II. Compare the toxic effects of these regimens in these patients. III. Compare the overall and failure-free survival of patients treated with these regimens.

IV. Compare the duration of complete and partial responses in patients treated with these regimens.

V. Determine the population pharmacokinetics of these regimens and correlate these parameters with the toxicity of these regimens and response rate in these patients.

VI. Compare the quality of life of patients treated with these regimens. VII. Determine the relationship of absolute and relative decrease in PSA and rate of PSA decrease with the likelihood and duration of response in patients treated with these regimens.

VIII. Determine whether a change in fibroblast growth factor levels in patients treated with suramin can be associated with the pharmacokinetics of suramin or the likelihood of clinical response in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease site (bone only vs soft tissue), CALGB/Zubrod performance status (0 or 1 vs 2), number of prior hormonal therapies (1 or 2 vs 3), and participating center. Patients are randomized to 1 of 3 treatment arms.

Arm I: Patients receive low-dose suramin IV over 1 hour on days 1, 2, 8, 9, 29, 30, 36, 37, 57, 58, 64, and 65 in the absence of disease progression or unacceptable toxicity.

Arm II: Patients receive intermediate-dose suramin as in arm I.

Arm III: Patients receive high-dose suramin as in arm I. Patients with new progression after partial or complete response may receive additional courses, at the discretion of the study chairperson, beginning at least 12 weeks after completion of the first course and continuing in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed.

Patients are followed every 4 weeks until disease progression and then periodically for new primary cancer(s) and survival.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically proven adenocarcinoma of the prostate with progressive metastatic or progressive regional nodal disease

PSA evidence of progression defined as at least 50% increase over baseline on at least 2 measurements at least 2 weeks apart

Measurable disease preferred but not required

Bone scan abnormalities acceptable provided PSA at least 10 ng/mL
No minimum PSA value required if measurable disease present
Progression after or during an adequate trial of hormonal therapy

No more than 3 prior hormonal interventions for progressive disease

One prior hormonal intervention is defined by any of the following:

Concurrent testicular and adrenal androgen ablation (e.g., leuprolide, goserelin, orchiectomy, or diethylstilbestrol (DES) plus flutamide, bicalutamide, nilutamide, megestrol, or other antiandrogen)
Initial LHRH agonist followed by orchiectomy provided no progression prior to orchiectomy
Prior intermittent androgen deprivation on protocol SWOG-9346
Corticosteroids for metastatic disease or in conjunction with aminoglutethimide or ketoconazole

Two prior hormonal interventions are defined by the following:

Antiandrogen given for disease progression more than 3 months after initial hormonal therapy
Prior neoadjuvant or adjuvant deprivation for treatment of nonmetastatic disease not considered a prior hormonal intervention

Antiandrogen withdrawal not considered a separate hormonal intervention

At least 4 weeks since antiandrogen withdrawal or megestrol withdrawal
Failure to respond to (i.e., no decrease in PSA at 2 and 4 weeks) or progression after a transient response to antiandrogen withdrawal or megestrol withdrawal required
Primary testicular androgen suppression (e.g., LHRH agonist or DES) continues during study
No brain metastases or other CNS disease

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

CALGB 0-2 OR
Zubrod 0-2

Life expectancy:

At least 3 months

Hematopoietic:

WBC at least 3,000/mm3
Absolute neutrophil count at least 1,200/mm3
Platelet count at least 100,000/mm3
Hemoglobin at least 9 g/dL
Fibrinogen at least 200 mg/dL
No prior hemorrhagic or thrombotic disorders

Hepatic:

Bilirubin normal
AST/ALT no greater than 2.5 times normal
Prothrombin time, partial thromboplastin time, and thrombin time normal

Renal:

Creatinine clearance at least 70 mL/min

Other:

No primary muscle disease
No active, uncontrolled bacterial, viral, or fungal infection
No grade 1 or worse peripheral neuropathy
No underlying medical condition that would preclude study
No other serious medical illness that limits survival to less than 3 months
No psychiatric condition that would preclude informed consent
No other malignancy within the past 5 years except inactive nonmelanomatous skin cancer or adequately treated stage I or II cancer in remission

PRIOR CONCURRENT THERAPY:

Biologic therapy:

No prior immunotherapy for metastatic disease

Chemotherapy:

No prior chemotherapy (including estramustine) for metastatic disease

Endocrine therapy:

No concurrent megestrol or other hormonal agents
No concurrent systemic or inhaled corticosteroids (intranasal and topical steroids allowed)

Radiotherapy:

At least 4 weeks since prior radiotherapy (8 weeks for strontium therapy)

Other:

No prior experimental therapy for metastatic disease
No concurrent heparin, warfarin, or aspirin

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

390

Study ID:

NCT00002723

Recruitment Status:

Completed

Sponsor:

National Cancer Institute (NCI)

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There are 26 Locations for this study

See Locations Near You

Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago Illinois, 60611, United States
Veterans Affairs Medical Center - Lakeside Chicago
Chicago Illinois, 60611, United States
CCOP - Carle Cancer Center
Urbana Illinois, 61801, United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids Iowa, 52403, United States
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States
CCOP - Ann Arbor Regional
Ann Arbor Michigan, 48106, United States
CCOP - Kalamazoo
Kalamazoo Michigan, 49007, United States
CCOP - Duluth
Duluth Minnesota, 55805, United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis Minnesota, 55417, United States
CCOP - Metro-Minnesota
Saint Louis Park Minnesota, 55416, United States
Veterans Affairs Medical Center - East Orange
East Orange New Jersey, 07018, United States
CCOP - Northern New Jersey
Hackensack New Jersey, 07601, United States
Albert Einstein Comprehensive Cancer Center
Bronx New York, 10461, United States
CCOP - Merit Care Hospital
Fargo North Dakota, 58122, United States
Ireland Cancer Center
Cleveland Ohio, 44106, United States
CCOP - Toledo Community Hospital Oncology Program
Toledo Ohio, 43623, United States
CCOP - Geisinger Clinic and Medical Center
Danville Pennsylvania, 17822, United States
CCOP - MainLine Health
Wynnewood Pennsylvania, 19096, United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls South Dakota, 57104, United States
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
Nashville Tennessee, 37212, United States
Vanderbilt-Ingram Cancer Center
Nashville Tennessee, 37232, United States
Veterans Affairs Medical Center - Madison
Madison Wisconsin, 53705, United States
University of Wisconsin Comprehensive Cancer Center
Madison Wisconsin, 53792, United States
CCOP - Marshfield Medical Research and Education Foundation
Marshfield Wisconsin, 54449, United States
Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee Wisconsin, 53295, United States
Pretoria Academic Hospitals
Pretoria , 0001, South Africa

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

390

Study ID:

NCT00002723

Recruitment Status:

Completed

Sponsor:


National Cancer Institute (NCI)

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