Search / Trial NCT00001266

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

Launched by NATIONAL CANCER INSTITUTE (NCI) · Nov 3, 1999

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Trial Information

Current as of July 23, 2024

Completed

Keywords

Bayesian Hydroxy Flutamide Combined Androgen Ablation Prostate Specific Antigen

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 ...

Gender

Male

Eligibility 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.

Attachments

readout_NCT00001266_2024-07-23.pdf

4.5 MB

NCT00001266_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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