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

February 27, 2013 updated by: National Cancer Institute (NCI)

A PHASE III STUDY OF THREE DIFFERENT DOSES OF SURAMIN (NSC #34936) ADMINISTERED WITH A FIXED DOSING SCHEDULE IN PATIENTS WITH ADVANCED PROSTATE CANCER

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

390

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
      • Pretoria, South Africa, 0001
        • Pretoria Academic Hospitals
  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611-3013
        • Robert H. Lurie Comprehensive Cancer Center, Northwestern University
      • Chicago, Illinois, United States, 60611
        • Veterans Affairs Medical Center - Lakeside Chicago
      • Urbana, Illinois, United States, 61801
        • CCOP - Carle Cancer Center
    • Iowa
      • Cedar Rapids, Iowa, United States, 52403-1206
        • CCOP - Cedar Rapids Oncology Project
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • CCOP - Ann Arbor Regional
      • Kalamazoo, Michigan, United States, 49007-3731
        • CCOP - Kalamazoo
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • CCOP - Duluth
      • Minneapolis, Minnesota, United States, 55417
        • Veterans Affairs Medical Center - Minneapolis
      • Saint Louis Park, Minnesota, United States, 55416
        • CCOP - Metro-Minnesota
    • New Jersey
      • East Orange, New Jersey, United States, 07018-1095
        • Veterans Affairs Medical Center - East Orange
      • Hackensack, New Jersey, United States, 07601
        • CCOP - Northern New Jersey
    • New York
      • Bronx, New York, United States, 10461
        • Albert Einstein Comprehensive Cancer Center
    • North Dakota
      • Fargo, North Dakota, United States, 58122
        • CCOP - Merit Care Hospital
    • Ohio
      • Cleveland, Ohio, United States, 44106-5065
        • Ireland Cancer Center
      • Toledo, Ohio, United States, 43623-3456
        • CCOP - Toledo Community Hospital Oncology Program
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822-2001
        • CCOP - Geisinger Clinic and Medical Center
      • Wynnewood, Pennsylvania, United States, 19096
        • CCOP - MainLine Health
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
        • CCOP - Sioux Community Cancer Consortium
    • Tennessee
      • Nashville, Tennessee, United States, 37232-6838
        • Vanderbilt-Ingram Cancer Center
      • Nashville, Tennessee, United States, 37212
        • Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
    • Wisconsin
      • Madison, Wisconsin, United States, 53792-6164
        • University of Wisconsin Comprehensive Cancer Center
      • Madison, Wisconsin, United States, 53705
        • Veterans Affairs Medical Center - Madison
      • Marshfield, Wisconsin, United States, 54449
        • CCOP - Marshfield Medical Research and Education Foundation
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin
      • Milwaukee, Wisconsin, United States, 53295
        • Veterans Affairs Medical Center - Milwaukee (Zablocki)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Low dose suramin
Drug: suramin
3.192g/square meter total dose given decreasing concentrations in 250 cc normal saline IV over 1 hour on days 1,2,8,9,29,30,36,37,57,58,64,and 65.
Other Names:
  • NSC #34936
Drug: suramin
5.320 g/square meter total dose given in decreasing concentrations in 250 cc normal saline via IV over 1 hour on days 1,2,8,9,29,30,36,37,57,58,64,and 65
Other Names:
  • NSC #34936
EXPERIMENTAL: Intermediate dose suramin
Drug: suramin
3.192g/square meter total dose given decreasing concentrations in 250 cc normal saline IV over 1 hour on days 1,2,8,9,29,30,36,37,57,58,64,and 65.
Other Names:
  • NSC #34936
Drug: suramin
5.320 g/square meter total dose given in decreasing concentrations in 250 cc normal saline via IV over 1 hour on days 1,2,8,9,29,30,36,37,57,58,64,and 65
Other Names:
  • NSC #34936
EXPERIMENTAL: High dose suramin
Drug: Suramin
7.661 g/square meter toal dose given in decreasing concentrations in 250 cc normal saline IV over 1 hour on days 1,2,8,9,29,30,36,37,5,58,64,and 65.
Other Names:
  • NSC #34936

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response
Time Frame: Week 12 and then monthly
PSA levels
Week 12 and then monthly
Response
Time Frame: Week 12 and every 12 weeks thereafter
Radiographic evaluation
Week 12 and every 12 weeks thereafter

Secondary Outcome Measures

Outcome Measure
Time Frame
Toxicity
Time Frame: pre-study, day 1, then every 2 weeks during treatment and every 8 weeks during follow up
pre-study, day 1, then every 2 weeks during treatment and every 8 weeks during follow up
Survival
Time Frame: post treatment until patient expires
post treatment until patient expires
Quality of Life
Time Frame: pre-study, 2 weeks post treatment, and every 12 weeks in follow up
pre-study, 2 weeks post treatment, and every 12 weeks in follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Collaborators

Eastern Cooperative Oncology Group
Southwest Oncology Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1996

Primary Completion (ACTUAL)

August 1, 2002

Study Completion (ACTUAL)

March 1, 2008

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

October 21, 2003

First Posted (ESTIMATE)

October 22, 2003

Study Record Updates

Last Update Posted (ESTIMATE)

February 28, 2013

Last Update Submitted That Met QC Criteria

February 27, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2012-02788
  • U10CA031946 (U.S. NIH Grant/Contract)
  • CALGB-9480
  • E-C9480
  • SWOG-9452
  • INT-0159
  • CDR0000064583 (REGISTRY: PDQ (Physician Data Query))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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