- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00058084
Ixabepilone Compared With Mitoxantrone and Prednisone in Treating Patients With Refractory Metastatic Prostate Cancer
A Randomized Phase II Study Of BMS 247550 Or Mitoxantrone And Prednisone In Patients With Taxane Resistant Hormone Refractory Prostate Cancer
Study Overview
Status
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. Determine the efficacy of ixabepilone (BMS-247550) vs mitoxantrone and prednisone, in terms of decline in prostate-specific antigen (PSA) levels, in patients with taxane-resistant, hormone-refractory metastatic prostate cancer.
SECONDARY OBJECTIVES:
I. Determine the safety of these regimens in these patients. II. Determine the objective response rate in patients with measurable disease who are treated with these regimens.
III. Determine the clinical activity of each of these regimens after crossover in patients who experience disease progression on their originally assigned treatment arm and switch to the other treatment arm.
OUTLINE: This is a randomized, crossover, multicenter study. Patients are stratified according to ECOG performance status (0 vs 1 or 2). Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive ixabepilone (BMS-247550) IV over 3 hours on day 1.
ARM II: Patients receive mitoxantrone IV over 30 minutes on day 1 and oral prednisone twice daily on days 1-21.In both arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients who progress while on treatment after at least 2 courses or discontinue treatment for any other reason may cross over to the other arm and receive treatment as above, beginning within 12 weeks of last study treatment on original arm.
Patients are followed every 3 months.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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California
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San Francisco, California, United States, 94143-0875
- UCSF Helen Diller Family Comprehensive Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Histologically confirmed adenocarcinoma of the prostate
- Metastatic disease (positive bone scan or measurable disease)
Progressive hormone-refractory disease
Based on 1 of the following:
- Transaxial imaging
- Rise in prostate-specific antigen (PSA)
- Radionuclide bone scan
Must have undergone primary hormonal treatment (e.g., orchiectomy or gonadotropin-releasing hormone analog with or without an antiandrogen) and demonstrated disease progression after antiandrogen discontinuation as defined below:
- Two consecutive rising PSA values, obtained at least 2 weeks apart, or documented osseous or soft tissue progression
- For patients receiving flutamide, at least 1 PSA value must be obtained at least 4 weeks after flutamide discontinuation
- For patients receiving bicalutamide or nilutamide, at least 1 PSA value must be obtained at least 6 weeks after antiandrogen discontinuation
- Ineligible if sole manifestation of progression is an increase in disease-related symptoms
Meets 1 of the following criteria:
- Measurable disease and an elevated PSA
Nonmeasurable disease and an elevated PSA, as follows:
- Positive bone scan
- PSA level at least 5 ng/mL, with increases on at least 2 successive occasions at least 2 weeks apart
- New metastatic lesions by radionuclide bone scan
- Must have received at least 2 courses of paclitaxel- or docetaxel-based therapy, with disease progression documented during therapy or no more than 60 days after cessation of therapy*
- Testosterone < 50 ng/dL
- No known active brain metastases
- Performance status - ECOG 0-2
- At least 12 weeks
- Granulocyte count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Bilirubin < 1.5 times upper limit of normal (ULN)
- AST and ALT < 3 times ULN
- Creatinine ≤ 1.5 times ULN
- Creatinine clearance > 40 mL/min
- Ejection fraction ≥ lower limit of normal by MUGA or echocardiogram
- No myocardial infarction within the past 6 months
- No significant cardiovascular disease
- No New York Heart Association class III or IV congestive heart failure
- No active angina pectoris
- Fertile patients must use effective contraception before, during, and for 3 months after study therapy
- No prior hypersensitivity reaction to agents containing Cremophor®EL
- No serious infection
- No nonmalignant medical illnesses that are uncontrolled or whose control would be jeopardized by complications of study therapy
- No psychiatric illness or social situation that would preclude study compliance
- No motor or sensory neuropathy grade 2 or greater
No "currently active" second malignancy except nonmelanoma skin cancer
- Patients are not considered to have a "currently active" malignancy provided they have completed therapy and are considered to have less than a 30% risk of relapse
- No concurrent prophylactic colony-stimulating factors for myelosuppression
- See Disease Characteristics
- No more than 1 prior chemotherapy regimen
- No prior mitoxantrone or epothilone
- No other concurrent chemotherapy
- See Disease Characteristics
At least 4 weeks since prior antiandrogens (e.g., flutamide) (6 weeks for bicalutamide or nilutamide)
- Patients must continue primary androgen deprivation therapy with luteinizing hormone-releasing hormone agonist during study if prior orchiectomy was not performed
- At least 4 weeks since prior systemic (including oral) corticosteroids except corticosteroids as part of first-line chemotherapy tapered off over 10-14 days prior to study entry
- At least 4 weeks since any prior hormonal therapy, including megestrol or finasteride
- No other concurrent systemic steroids
- At least 4 weeks since prior radiotherapy
- More than 8 weeks since prior radiopharmaceuticals (e.g., strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium)
- No concurrent radiotherapy
- See Disease Characteristics
- At least 4 weeks since prior herbal products known to decrease PSA levels (e.g., Saw Palmetto or PC-SPES)
- More than 4 weeks since other prior antiprostate cancer therapy
- More than 4 weeks since prior systemic therapies for prostate cancer
- No other concurrent investigational agents
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm I
Patients receive ixabepilone (BMS-247550) IV over 3 hours on day 1.
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Given IV
Other Names:
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Experimental: Arm II
Patients receive mitoxantrone IV over 30 minutes on day 1 and oral prednisone twice daily on days 1-21.
In both arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
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Given orally
Other Names:
Given IV
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response to the randomized treatment as determined by > 50% PSA response as measured by RECIST criteria
Time Frame: Up to 3 months
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The frequency of response with 95% confidence limits for a binomial outcome will be calculated.
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Up to 3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of any toxicity by grade
Time Frame: Up to 3 months
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Up to 3 months
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Response duration
Time Frame: From the date PR or CR is first determined until the first evidence of progressive disease, assessed up to 3 months
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Will be estimated using the Kaplan-Meier product limit method.
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From the date PR or CR is first determined until the first evidence of progressive disease, assessed up to 3 months
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Time to progressive disease
Time Frame: From the date protocol therapy is started until the first evidence of progressive disease, assessed up to 3 months
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Will be estimated using the Kaplan-Meier product limit method.
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From the date protocol therapy is started until the first evidence of progressive disease, assessed up to 3 months
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Frequency of response to third-line (crossover) therapy
Time Frame: Up to 3 months
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Estimates of response to third line treatment along with 95% confidence intervals will be calculated.
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Up to 3 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jonathan Rosenberg, University of California, San Francisco
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Male
- Prostatic Diseases
- Prostatic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Prednisone
- Mitoxantrone
- Epothilones
- Epothilone B
Other Study ID Numbers
- NCI-2012-02526
- N01CM62206 (U.S. NIH Grant/Contract)
- UCSF-02555
- CDR0000285731 (Registry Identifier: PDQ (Physician Data Query))
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.
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