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A Phase II Trial of Leuprolide + Flutamide + Suramin in Untreated Poor Prognosis Prostate Carcinoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00001266
First Posted: November 4, 1999
Last Update Posted: March 4, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institutes of Health Clinical Center (CC)
  Purpose
One current hypothesis as to what limits duration of initial hormone response is the rapid emergence of hormone resistant prostate carcinoma cells. Suramin has shown effectiveness as a treatment for hormonally refractory prostate carcinoma. Survival was less in patients with high rather than low circulating androgen levels. Thus, suramin might slow the emergence of hormone refractory tumor cells while combined androgen ablation may maximize the effectiveness of suramin. In this trial, we will pilot this concept.

Condition Intervention Phase
Prostatic Neoplasm Drug: Suramin Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase II Trial of Leuprolide + Flutamide + Suramin in Untreated Poor Prognosis Prostate Carcinoma

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 70
Study Start Date: October 1990
Estimated Study Completion Date: August 2003
Detailed Description:
The purpose of this study is to assess the potential for combined androgen blockage (Leuprolide and Flutamide), given with suramin (a growth factor inhibitor) to improve the clinical outcome(s) in a cohort of patients with bulky metastatic prostate cancer. Combined androgen blockage is currently the standard of care for such individuals. Suramin has shown reproducible activity in individuals with androgen independent disease. Since these two approaches are independent of one another - on the molecular level, and in clinical results - it is hoped that the combination of these two approaches will result in improved response rates and in improved survival.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA:

Patients must have a histologic diagnosis of carcinoma of the prostate and must not have had a trial of hormonal therapy or chemotherapy.

Patients must be 18 years of age and an SGOT/SGPT within 2 times of normal.

Patients must have stage D2 prostate carcinoma or State D1 disease with a Gleason grade 7 or above (poorly differentiated).

No other malignancy except curatively treated basal cell cancer of the skin.

Performance status ECOG of 0-3.

Ability to give informed consent.

No history of bleeding diathesis. Patients with a history of peptic ulcer disease will be eligible if the ulcer is shown to be resolved by a barium study.

No history of cerebrovascular event, either thrombotic or hemorrhagic.

No current clinical signs of congestive heart failure, angina pectoris or myocardial infarction. Patient cannot be on calcium channel blockers such as Nifedipine, Diltiazem, or Verapamil.

No clinical or radiographic evidence of brain metastases.

Patients with extensive liver replacement (greater than 50%) by tumor will be ineligible.

Patients must have a creatinine lest than or equal 2.5 mg/dl or creatinine clearance of greater than or equal to 40 ml/min.

Patients must have adequate hepatic function (bilirubin less than 1.5mg%).

If the patient has white cells in his urinalysis or other evidence of a urinary tract infection, this must be evaluated and appropriate therapy initiation prior to the initiation of therapy.

Patients must not have received chemotherapy.

An absolute granulocyte count greater than 1,500; platelet count greater than 100,000; Fibrinogen greater than 200 mg/dl; Hgb greater than or equal to 9 gm/dl.

Reliability of the patient to take oral medication, go home and return for follow-up and treatment.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001266


Locations
United States, Maryland
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00001266     History of Changes
Other Study ID Numbers: 910014
91-C-0014
First Submitted: November 3, 1999
First Posted: November 4, 1999
Last Update Posted: March 4, 2008
Last Verified: August 2003

Keywords provided by National Institutes of Health Clinical Center (CC):
Bayesian
Hydroxy-Flutamide
Combined Androgen Ablation
Prostate Specific Antigen

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Leuprolide
Flutamide
Suramin
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antinematodal Agents
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Trypanocidal Agents
Antiprotozoal Agents