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

Primary Purpose

Prostatic Neoplasm

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Suramin
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Neoplasm focused on measuring Bayesian, Hydroxy-Flutamide, Combined Androgen Ablation, Prostate Specific Antigen

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • National Cancer Institute (NCI)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00001266
Brief Title
A Phase II Trial of Leuprolide + Flutamide + Suramin in Untreated Poor Prognosis Prostate Carcinoma
Official Title
A Phase II Trial of Leuprolide + Flutamide + Suramin in Untreated Poor Prognosis Prostate Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2003
Overall Recruitment Status
Completed
Study Start Date
October 1990 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasm
Keywords
Bayesian, Hydroxy-Flutamide, Combined Androgen Ablation, Prostate Specific Antigen

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
70 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Suramin

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
National Cancer Institute (NCI)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
2465303
Citation
Ashby H, DiMattina M, Linehan WM, Robertson CN, Queenan JT, Albertson BD. The inhibition of human adrenal steroidogenic enzyme activities by suramin. J Clin Endocrinol Metab. 1989 Feb;68(2):505-8. doi: 10.1210/jcem-68-2-505.
Results Reference
background
PubMed Identifier
3279409
Citation
Belanger A, Giasson M, Couture J, Dupont A, Cusan L, Labrie F. Plasma levels of hydroxy-flutamide in patients with prostatic cancer receiving the combined hormonal therapy: an LHRH agonist and flutamide. Prostate. 1988;12(1):79-84. doi: 10.1002/pros.2990120110.
Results Reference
background
PubMed Identifier
1690883
Citation
Badalament RA, Drago JR. Prostate cancer. Promising advances that may alter survival rates. Postgrad Med. 1990 Apr;87(5):65-7, 70-2. doi: 10.1080/00325481.1990.11704627.
Results Reference
background

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

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