- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00001266
A Phase II Trial of Leuprolide + Flutamide + Suramin in Untreated Poor Prognosis Prostate Carcinoma
Study Overview
Detailed Description
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- National Cancer Institute (NCI)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 910014
- 91-C-0014
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.
Clinical Trials on Prostatic Neoplasm
-
National Cancer Institute (NCI)CompletedProstatic Neoplasms | Prostate Cancer | Neoplasm, Prostate | Neoplasm,ProstaticUnited States
-
Michael Graham PhD, MDUniversity of Iowa; Holden Comprehensive Cancer CenterCompletedProstate Cancer | Prostatic Neoplasms, Castration-Resistant | Prostatic Neoplasm | Prostatic Neoplasm of Uncertain BehaviorUnited States
-
Rio de Janeiro State UniversityCompletedProstatic Cancer | Prostatic NeoplasmBrazil
-
Advanced Accelerator ApplicationsTerminatedProstatic NeoplasmUnited States, Spain
-
Sismanoglio General HospitalNational and Kapodistrian University of AthensCompletedProstatic NeoplasmGreece
-
Sharp HealthCareCompleted
-
AHS Cancer Control AlbertaCross Cancer InstituteCompleted
-
Debiopharm International SACompletedProstatic NeoplasmSouth Africa
-
Centre Hospitalier Universitaire de BesanconRecruiting
-
Fondazione del Piemonte per l'OncologiaCompleted
Clinical Trials on Suramin
-
Cancer Research UKCompleted
-
University of ArkansasNational Cancer Institute (NCI)CompletedMultiple Myeloma and Plasma Cell NeoplasmUnited States
-
National Cancer Institute (NCI)CompletedCarcinoma, Transitional Cell | Bladder NeoplasmsUnited States
-
Emory UniversityNational Cancer Institute (NCI)CompletedBrain and Central Nervous System TumorsUnited States
-
National Cancer Institute (NCI)Eastern Cooperative Oncology Group; Southwest Oncology GroupCompletedLow, Intermediate, or High Dose Suramin in Treating Patients With Hormone-Refractory Prostate CancerProstate CancerUnited States, South Africa
-
Sidney Kimmel Comprehensive Cancer Center at Johns...National Cancer Institute (NCI)CompletedBrain and Central Nervous System TumorsUnited States
-
PaxmedicaCompleted
-
First Affiliated Hospital of Zhejiang UniversityGuangdong Kangda Pharmaceutical Co., LtdUnknownHand, Foot and Mouth DiseaseChina
-
Mayo ClinicNational Cancer Institute (NCI)CompletedBreast Cancer | Colorectal Cancer | Prostate Cancer | Unspecified Adult Solid Tumor, Protocol Specific | Adrenocortical CarcinomaUnited States
-
Southwest Oncology GroupNational Cancer Institute (NCI)TerminatedAdrenocortical CarcinomaUnited States