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Chemotherapy in Treating Patients With Prostate Cancer

Sponsor
Daiichi Sankyo, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00004045
Collaborator
(none)
2
Locations
26
Duration (Months)

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.

PURPOSE: Phase II trial to study the effectiveness of DX-8951f in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.

Condition or Disease Intervention/Treatment Phase
  • Drug: exatecan mesylate
 Phase 2

Detailed Description

OBJECTIVES: I. Determine the antitumor activity of DX-8951f as measured by PSA response in patients with hormone refractory prostate cancer. II. Determine the antitumor activity of this drug in the subpopulation of these patients with measurable disease. III. Evaluate the quantitative and qualitative toxicities of this drug in these patients. IV. Evaluate the pharmacokinetics of this drug in these patients.

OUTLINE: This is a multicenter study. Patients receive DX-8951f IV over 30 minutes daily for 5 days. Courses repeat every 21 days. Treatment continues in the absence of unacceptable toxicity or disease progression. Patients with no evidence of PSA decrease by the start of course 3 receive no further treatment. Patients are followed every 3 months until death.

PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study.

Study Design

Study Type:
Interventional
Primary Purpose:
Treatment
Official Title:
A Phase II Study of Intravenous DX-8951f Administered Daily for Five Days Every Three Weeks to Patients With Hormone-Refractory Prostate Cancer
Study Start Date :
Jun 1, 1999
Actual Primary Completion Date :
Aug 1, 2001
Actual Study Completion Date :
Aug 1, 2001

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No

    DISEASE CHARACTERISTICS: Histologically or cytologically confirmed prostate carcinoma Metastatic disease Documented progression of prostate cancer while receiving androgen ablative therapy (i.e., surgical or chemical castration and a serum testosterone level in the castrate range) Documented hormone therapy resistance defined as: PSA rise on 3 occasions not less than 4 weeks apart Any evidence of progressive measurable disease PSA must be above 20 ng/mL prior to study entry No brain metastases

    PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Hemoglobin at least 9.0 g/dL Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT/SGPT no greater than 2 times upper limit of normal (ULN) (5 times ULN if liver metastases present) Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No active congestive heart failure No uncontrolled angina No myocardial infarction within the past 6 months Other: Fertile patients must use effective contraception No uncontrolled pain requiring irradiation No concurrent serious infection No other malignancy within the past 5 years except nonmelanoma skin cancer No overt psychosis, mental disability, or incompetence

    PRIOR CONCURRENT THERAPY: Biologic therapy: No prophylactic colony stimulating factors to prevent neutropenia No concurrent biologic therapy Chemotherapy: No more than 1 prior cytotoxic chemotherapy regimen No concurrent cytotoxic chemotherapy Endocrine therapy: See Disease Characteristics At least 6 weeks since prior peripheral antiandrogens (e.g., flutamide) No concurrent steroid therapy initiated within past 2 months Current LHRH agonist therapy should continue through study Radiotherapy: At least 4 weeks since prior radiotherapy (except low dose, non myelosuppressive) and recovered No prior irradiation to greater than 25% of bone marrow No prior strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium No concurrent radiotherapy Surgery: See Disease Characteristics At least 4 weeks since prior major surgery and recovered No concurrent surgery Other: No other concurrent anticancer treatment At least 28 days since investigational drugs, including analgesics or antiemetics No other investigational drugs during and for 28 days after study No concurrent drugs that induce or inhibit CYP3A enzyme No concurrent herbal preparations (e.g., PC-SPES)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 U.S. Oncology Research Inc. Houston Texas United States 77060
    2 Institute for Drug Development San Antonio Texas United States 78245-3217

    Sponsors and Collaborators

    • Daiichi Sankyo, Inc.

    Investigators

    • Study Chair: Robert L. DeJager, MD, FACP, Daiichi Sankyo, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Daiichi Sankyo, Inc.
    ClinicalTrials.gov Identifier:
    NCT00004045
    Other Study ID Numbers:
    • CDR0000067146
    • DAIICHI-8951A-PRT012
    • SACI-IDD-99-03
    • SLLH-BHS-99-0020
    First Posted:
    Apr 15, 2004
    Last Update Posted:
    May 16, 2012
    Last Verified:
    May 1, 2012
    Keywords provided by Daiichi Sankyo, Inc.
    stage IV prostate cancer
    recurrent prostate cancer
    Additional relevant MeSH terms:
    Prostatic Neoplasms
    Exatecan

    Study Results

    No Results Posted as of May 16, 2012