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Status:

COMPLETED

Treating Patients With Metastatic Prostate Cancer Not Responding to Hormone and Chemotherapy

Lead Sponsor:

National Cancer Institute (NCI)

Conditions:

Adenocarcinoma of the Prostate

Recurrent Prostate Cancer

Eligibility:

MALE

18+ years

Phase:

PHASE1

PHASE2

Brief Summary

This phase I/II trial is studying the side effects and best dose of ixabepilone and mitoxantrone hydrochloride when given together with prednisone and to see how well they work in treating patients wi...

Detailed Description

PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose (MTD) and dose-limiting toxicities of the combination of ixabepilone, mitoxantrone hydrochloride, and prednisone in patients with hormone-r...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Histologically confirmed adenocarcinoma of the prostate
  • Progressive metastatic disease (i.e., positive bone scan or measurable disease) despite castrate levels of testosterone (either from orchiectomy or luteinizing hormone-releasing hormone \[LHRH\] agonist therapy)
  • Progressive disease after discontinuing hormonal therapy
  • Progressive disease is based on any of the following\*:
  • Transaxial imaging
  • Rise in prostate-specific antigen (PSA)
  • Radionuclide bone scan (must show new metastatic lesions)
  • Nonmeasurable or measurable disease
  • For measurable disease, progression is defined by RECIST criteria
  • Positive bone scan and elevated PSA required for nonmeasurable disease
  • PSA evidence of progressive prostate cancer during or after first-line chemotherapy consists of a PSA level ≥ 2 ng/mL that has risen on ≥ 2 successive occasions ≥ 1 week apart
  • Received ≥ 3 prior courses of paclitaxel- or docetaxel-based therapy, with disease progression documented during therapy or after cessation of therapy
  • No more than 1 prior chemotherapy regimen
  • Re-treatment with the same taxane-based regimen allowed
  • Changes in prior chemotherapy regimen (addition of other agents) for disease progression are considered 2 chemotherapy regimens, and are not allowed
  • PSA ≥ 2 ng/mL
  • Testosterone \< 50 ng/dL
  • Patients must continue primary androgen deprivation with LHRH analogue if they have not undergone orchiectomy
  • No known active brain metastases
  • ECOG performance status 0-2
  • Life expectancy ≥ 12 weeks
  • Creatinine ≤ 1.5 times upper limit of normal (ULN) OR creatinine clearance \> 40 mL/min
  • ALT and AST \< 2.5 times ULN
  • Granulocyte count ≥ 2,000/mm³
  • Platelet count ≥ 100,000/mm³
  • Bilirubin \< 1.5 times ULN
  • Ejection fraction normal by MUGA scan or echocardiogram
  • No significant cardiovascular disease, including any of the following:
  • Congestive heart failure (New York Heart Association class III-IV heart disease)
  • Active angina pectoris
  • Myocardial infarction within the past 6 months
  • No serious infections or nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by study therapy
  • No psychiatric illness or social situation that would preclude study compliance
  • No pre-existing motor or sensory peripheral neuropathy \> grade 1
  • No known prior severe hypersensitivity reactions to agents containing Cremophor® EL
  • No "currently active" second malignancy other than nonmelanoma skin cancer
  • Patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered to be at \< 30% risk of relapse
  • Fertile patients must use effective contraception prior to, during, and for 3 months after completion of study treatment
  • See Disease Characteristics
  • No prior mitoxantrone hydrochloride, ixabepilone, or other epothilones
  • At least 4 weeks since prior hormonal therapy (i.e., any dose of megestrol, finasteride, or any herbal product known to decrease PSA levels \[e.g., saw palmetto or PC-SPES\]) other than LHRH agonist or a stable dose of corticosteroids from a prior chemotherapy regimen
  • More than 4 weeks since other prior systemic therapies for prostate cancer
  • At least 4 weeks since prior radiation therapy
  • More than 8 weeks since prior radiopharmaceuticals (e.g., strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium)
  • No concurrent moderate to strong CYP3A4 inhibitors
  • No concurrent prophylactic colony-stimulating factors
  • No concurrent radiotherapy

Exclusion

    Key Trial Info

    Start Date :

    April 1 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    November 1 2010

    Estimated Enrollment :

    100 Patients enrolled

    Trial Details

    Trial ID

    NCT00331344

    Start Date

    April 1 2006

    End Date

    November 1 2010

    Last Update

    October 31 2017

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, United States, 94143-0875

    2

    University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, United States, 53792