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

Sponsor
CTI BioPharma (Industry)
Overall Status
Terminated
CT.gov ID
NCT00004026
Collaborator
(none)
80
Enrollment
7
Locations
73
Actual Duration (Months)
11.4
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Primary Purpose:
Treatment
Official Title:
A Phase II Study of CT-2584 Mesylate in Patients With Hormone Refractory Prostate Cancer
Actual Study Start Date :
Dec 1, 1998
Actual Primary Completion Date :
Jan 1, 2005
Actual Study Completion Date :
Jan 1, 2005

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 120 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No

    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

    Locations

    Site City State Country Postal Code
    1 Jonsson Comprehensive Cancer Center, UCLA Los Angeles California United States 90095-1781
    2 UCSF Cancer Center and Cancer Research Institute San Francisco California United States 94115-0128
    3 Stanley Scott Cancer Center New Orleans Louisiana United States 70112
    4 Johns Hopkins Oncology Center Baltimore Maryland United States 21287
    5 Our Lady of Mercy Medical Center Bronx New York United States 10466
    6 Herbert Irving Comprehensive Cancer Center New York New York United States 10032
    7 University of Washington Medical Center Seattle Washington United States 98195-6043

    Sponsors and Collaborators

    • CTI BioPharma

    Investigators

    • Study Chair: Carolyn Paradise, MD, CTI BioPharma

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00004026
    Other Study ID Numbers:
    • CTI-1038
    • CDR0000067257
    • CPMC-IRB-8781
    First Posted:
    Aug 27, 2004
    Last Update Posted:
    Oct 19, 2020
    Last Verified:
    Oct 1, 2020
    Keywords provided by , ,
    adenocarcinoma of the prostate
    stage IV prostate cancer
    recurrent prostate cancer
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    No Results Posted as of Oct 19, 2020