- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00124566
Study of Irofulven in Patients With Hormone-refractory Prostate Cancer
Three-Arm Randomized Phase II Clinical Study of Irofulven/Prednisone, Irofulven/Capecitabine/Prednisone or Mitoxantrone/Prednisone in Docetaxel-Pretreated Hormone-Refractory Prostate Cancer Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Belo Horizonte, Brazil
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Porto Alegre, Brazil
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Rio de Janeiro, Brazil
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Alberta
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Calgary, Alberta, Canada
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British Columbia
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Vancouver, British Columbia, Canada
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Manitoba
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Winnipeg, Manitoba, Canada
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Ontario
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London, Ontario, Canada
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Quebec
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Montreal, Quebec, Canada
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Santiago, Chile
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Zagreb, Croatia
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Avignon, France
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Orleans, France
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Paris, France
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Saint-Brieuc, France
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Saint-Gregoire, France
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Lima, Peru
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Bucharest, Romania
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Cluj-Napoca, Romania
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Arkhangelsk, Russian Federation
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Chelyabinsk, Russian Federation
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Moscow, Russian Federation
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Arkansas
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Hot Springs, Arkansas, United States
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Jonesboro, Arkansas, United States
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California
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Greenbrae, California, United States
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Colorado
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Colorado Springs, Colorado, United States
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Florida
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Bonita Springs, Florida, United States
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Bradenton, Florida, United States
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Cape Coral, Florida, United States
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Ft. Meyers, Florida, United States
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Naples, Florida, United States
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Port Charlotte, Florida, United States
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Sarasota, Florida, United States
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Venice, Florida, United States
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Georgia
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Atlanta, Georgia, United States
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Augusta, Georgia, United States
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Macon, Georgia, United States
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Marietta, Georgia, United States
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Illinois
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Chicago, Illinois, United States
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Minnesota
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Minneapolis, Minnesota, United States
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Montana
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Billings, Montana, United States
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New York
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Albany, New York, United States
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East Setauket, New York, United States
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Ohio
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Kettering, Ohio, United States
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South Carolina
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Greenville, South Carolina, United States
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Tennessee
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Nashville, Tennessee, United States
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Texas
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Dallas, Texas, United States
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Ft. Worth, Texas, United States
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Tyler, Texas, United States
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Washington
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Spokane, Washington, United States
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Wisconsin
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Marshfield, Wisconsin, United States
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
To be included in the study, patients must meet the following criteria:
- Cancer of the prostate confirmed by a biopsy sample.
- 18 years of age or older.
- Disease must have spread beyond the prostate as proven by chest x ray, abdominal and pelvic computed tomography (CT) scan, bone scan or clinical examination.
- At least one prior hormonal treatment with documented disease progression during hormone therapy.
- One previous line of chemotherapy that included Taxotere® (as monotherapy or in combination). This could be in addition to estramustine single agent therapy.
- Disease progression during prior Taxotere-based therapy or within 3 months of discontinuing.
- Recovered from any toxic effects of prior chemotherapy, radiotherapy and surgery.
- Recovered from any toxic effects associated with other investigational drugs, if applicable.
- Signed informed consent obtained prior to initiation of any study-specific procedures or treatment.
Exclusion Criteria:
Patients cannot participate in the study if any of the following apply:
- Unable to use prednisone.
- Prior treatment with irofulven, capecitabine (Xeloda), continuous/protracted infusion 5-FU (5-fluorouracil) (infusion duration greater than or equal to 24 hours), other fluoropyrimidines or mitoxantrone.
- Ongoing treatment with a corticosteroid at a prednisone-equivalent dose > 10 mg/day.
- More than 1 prior treatment with either 153Sm or 89Sr, or radioisotope treatment within 8 weeks prior to entering this study.
- Initiation of treatment with bisphosphonate agents (e.g., pamidronate, etidronate) within 2 months of entering the study. Pre-existing treatment with bisphosphonate agents is to be continued during this study.
- Treatment with warfarin and/or phenytoin within 14 days before entering this study or during the study period.
Please note: There are additional inclusion/exclusion criteria. The study center will determine if patients meet all of the criteria. If patients do not qualify for the trial, study personnel will explain the reasons. If patients do qualify, study personnel will explain the trial in detail and answer any questions. Patients can then decide if they wish to participate.
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 |
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Experimental: 1
Irofulven + prednisone
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Subjects will receive irofulven in a 30 minute intravenous (IV) infusion at a dose of 0.45 mg/kg on Days 1 and 8 every 3 weeks.
Subjects will also receive oral prednisone at a dose of 10 mg per day in the morning.
Subjects will receive irofulven in a 30 minute intravenous (IV) infusion at a dose of 0.4 mg/kg on Days 1 and 15 every 4 weeks.
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Experimental: 2
Irofulven + capecitabine + prednisone
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Subjects will receive irofulven in a 30 minute intravenous (IV) infusion at a dose of 0.45 mg/kg on Days 1 and 8 every 3 weeks.
Subjects will also receive oral prednisone at a dose of 10 mg per day in the morning.
Subjects will receive irofulven in a 30 minute intravenous (IV) infusion at a dose of 0.4 mg/kg on Days 1 and 15 every 4 weeks.
Subjects will receive oral capecitabine at a dose of 1000 mg/m^2 twice daily for 15 days every 28 days.
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Active Comparator: 3
Mitoxantrone + prednisone
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Subjects will also receive oral prednisone at a dose of 10 mg per day in the morning.
Subjects will receive mitoxantrone in an intravenous (IV) infusion (5 to 15 minutes) at a dose of 12 mg/m^2 per day, once every 3 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Time to progression: RECIST (Response Evaluation Criteria in Solid Tumors) criteria
Time Frame: Between randomization and study discontinuation or disease progression, whichever occurs later.
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Between randomization and study discontinuation or disease progression, whichever occurs later.
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Time to progression: Prostate-specific antigen (PSA) evolution (Prostate-Specific Antigen Working Group Recommendations [PSAWGR criteria]).
Time Frame: Between randomization and study discontinuation or disease progression, whichever occurs later.
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Between randomization and study discontinuation or disease progression, whichever occurs later.
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Efficacy: Overall survival; objective response rate and PSA response rate according to RECIST and PSAWGR criteria, respectively.
Time Frame: Between randomization and death.
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Between randomization and death.
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Determine safety profile of each treatment arm: incidence and severity of adverse events (AEs), serious AEs, and laboratory abnormalities.
Time Frame: Between randomization until a minimum of 30 days after last dose of study drug; treatment-related AEs will be followed until resolution.
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Between randomization until a minimum of 30 days after last dose of study drug; treatment-related AEs will be followed until resolution.
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Assess pain response in patients with significant pain at baseline using Tannock criteria and McGill-Melzack Pain Questionnaire.
Time Frame: Seven days prior to randomization and prior to each new cycle of study drug administration.
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Seven days prior to randomization and prior to each new cycle of study drug administration.
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Quality of life (QOL) as measured by the Prostate Cancer Specific Quality of Life Instrument (PROSQOLI).
Time Frame: Between baseline and study drug discontinuation.
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Between baseline and study drug discontinuation.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
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
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Capecitabine
- Prednisone
- Mitoxantrone
- Irofulven
Other Study ID Numbers
- IROF-018
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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