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

Phase 2
Not Enrolling
Prostatic Neoplasm

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Trial Information

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

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.

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment


United States: Federal Government

Study ID:




Start Date:

October 1990

Completion Date:

August 2003

Related Keywords:

  • Prostatic Neoplasm
  • Bayesian
  • Hydroxy-Flutamide
  • Combined Androgen Ablation
  • Prostate Specific Antigen
  • Neoplasms
  • Carcinoma
  • Prostatic Neoplasms



National Cancer Institute (NCI) Bethesda, Maryland  20892