CT-2584 in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Previous Therapy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2007 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00004026
First received: November 1, 1999
Last updated: February 6, 2009
Last verified: June 2007
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. CT-2584 may stop the growth of prostate cancer by stopping blood flow to the tumor.

PURPOSE: Randomized phase II trial to study the effectiveness of CT-2584 in treating patients who have metastatic prostate cancer that has not responded to previous therapy.


Condition Intervention Phase
Prostate Cancer
Drug: CT-2584
Drug: chemotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Phase II Study of CT-2584 Mesylate in Patients With Hormone Refractory Prostate Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 80
Study Start Date: December 1998
Detailed Description:

OBJECTIVES: I. Compare the efficacy, safety, and pharmacokinetics of 2 different treatment schedules of CT-2584 in patients with hormone refractory, metastatic adenocarcinoma of the prostate.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms: Arm I: Patients receive CT-2584 IV over 6 hours daily for 3 days every 3 weeks. Arm II: Patients receive CT-2584 IV over 6 hours once every 7 days for 3 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: Approximately 80 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically proven metastatic adenocarcinoma of the prostate Refractory to hormonal therapy Failed at least 1 nonhormonal therapy (prior radiotherapy allowed, but does not constitute nonhormonal therapy) No CNS metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: 60-100% Life expectancy: Not specified Hematopoietic: No known or suspected red blood cell disorder (e.g., hereditary spherocytosis, paroxysmal nocturnal hematuria, sickle cell trait, autoimmune hemolytic disorder) Hepatic: Bilirubin no greater than 1.5 mg/dL No severe liver dysfunction, particularly, no impaired hepatic synthetic functions as evidenced by prolonged prothrombin time or otherwise unexplained serum albumin less than 3 g/dL Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No evidence of congestive heart failure No clinically significant cardiac arrhythmia No prior or concurrent symptoms of acute coronary artery disease No significant cardiac valve disease (e.g., aortic stenosis, valve prosthesis) Pulmonary: No prior asthma during adulthood that required therapy Other: No prior seizures or drug related anaphylactic reactions No history of microangiopathy (e.g., cavenous hemangioma, prior thrombotic thrombocytopenic purpura)

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior systemic biologic therapy for prostate cancer and recovered Chemotherapy: At least 4 weeks since prior chemotherapy (12 weeks for strontium-89 and 6 weeks for bicalutamide) and recovered Endocrine therapy: See Disease Characteristics Radiotherapy: See Disease Characteristics No concurrent radiotherapy Surgery: At least 3 weeks since prior major thoracic or abdominal surgery Other: At least 4 weeks since other prior investigational drugs (except bisphosphonates) and recovered

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004026

Locations
United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, United States, 94115-0128
United States, Louisiana
Stanley Scott Cancer Center
New Orleans, Louisiana, United States, 70112
United States, Maryland
Johns Hopkins Oncology Center
Baltimore, Maryland, United States, 21287
United States, New York
Our Lady of Mercy Medical Center
Bronx, New York, United States, 10466
Herbert Irving Comprehensive Cancer Center
New York, New York, United States, 10032
United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98195-6043
Sponsors and Collaborators
CTI BioPharma
Investigators
Study Chair: Carolyn Paradise, MD CTI BioPharma
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00004026     History of Changes
Other Study ID Numbers: CDR0000067257, CTI-1038, CPMC-IRB-8781
Study First Received: November 1, 1999
Last Updated: February 6, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate
stage IV prostate cancer
recurrent prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Acetaminophen
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014