Study of Irofulven in Patients With Hormone-refractory Prostate Cancer
NCT ID: NCT00124566
Last Updated: 2016-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
135 participants
INTERVENTIONAL
2004-06-30
2009-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Irofulven + prednisone
Irofulven
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.
Prednisone
Subjects will also receive oral prednisone at a dose of 10 mg per day in the morning.
2
Irofulven + capecitabine + prednisone
Prednisone
Subjects will also receive oral prednisone at a dose of 10 mg per day in the morning.
Capecitabine
Subjects will receive oral capecitabine at a dose of 1000 mg/m\^2 twice daily for 15 days every 28 days.
Irofulven
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.
3
Mitoxantrone + prednisone
Prednisone
Subjects will also receive oral prednisone at a dose of 10 mg per day in the morning.
Mitoxantrone
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.
Interventions
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Irofulven
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.
Prednisone
Subjects will also receive oral prednisone at a dose of 10 mg per day in the morning.
Mitoxantrone
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.
Capecitabine
Subjects will receive oral capecitabine at a dose of 1000 mg/m\^2 twice daily for 15 days every 28 days.
Irofulven
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.
Eligibility Criteria
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Inclusion Criteria
1. Cancer of the prostate confirmed by a biopsy sample.
2. 18 years of age or older.
3. 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.
4. At least one prior hormonal treatment with documented disease progression during hormone therapy.
5. One previous line of chemotherapy that included Taxotere® (as monotherapy or in combination). This could be in addition to estramustine single agent therapy.
6. Disease progression during prior Taxotere-based therapy or within 3 months of discontinuing.
7. Recovered from any toxic effects of prior chemotherapy, radiotherapy and surgery.
8. Recovered from any toxic effects associated with other investigational drugs, if applicable.
9. Signed informed consent obtained prior to initiation of any study-specific procedures or treatment.
Exclusion Criteria
1. Unable to use prednisone.
2. 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.
3. Ongoing treatment with a corticosteroid at a prednisone-equivalent dose \> 10 mg/day.
4. More than 1 prior treatment with either 153Sm or 89Sr, or radioisotope treatment within 8 weeks prior to entering this study.
5. 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.
6. Treatment with warfarin and/or phenytoin within 14 days before entering this study or during the study period.
18 Years
MALE
No
Sponsors
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Eisai Inc.
INDUSTRY
Responsible Party
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Eisai Inc.
Locations
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Hot Springs, Arkansas, United States
Jonesboro, Arkansas, United States
Greenbrae, California, United States
Colorado Springs, Colorado, United States
Bonita Springs, Florida, United States
Bradenton, Florida, United States
Cape Coral, Florida, United States
Fort Meyers, Florida, United States
Naples, Florida, United States
Port Charlotte, Florida, United States
Sarasota, Florida, United States
Venice, Florida, United States
Atlanta, Georgia, United States
Augusta, Georgia, United States
Macon, Georgia, United States
Marietta, Georgia, United States
Chicago, Illinois, United States
Minneapolis, Minnesota, United States
Billings, Montana, United States
Albany, New York, United States
East Setauket, New York, United States
Kettering, Ohio, United States
Greenville, South Carolina, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Tyler, Texas, United States
Spokane, Washington, United States
Marshfield, Wisconsin, United States
Belo Horizonte, , Brazil
Porto Alegre, , Brazil
Rio de Janeiro, , Brazil
Calgary, Alberta, Canada
Vancouver, British Columbia, Canada
Winnipeg, Manitoba, Canada
London, Ontario, Canada
Montreal, Quebec, Canada
Santiago, , Chile
Zagreb, , Croatia
Avignon, , France
Orléans, , France
Paris, , France
Saint-Brieuc, , France
Saint-Grégoire, , France
Lima, , Peru
Bucharest, , Romania
Cluj-Napoca, , Romania
Arkhangelsk, , Russia
Chelyabinsk, , Russia
Moscow, , Russia
Countries
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Other Identifiers
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IROF-018
Identifier Type: -
Identifier Source: org_study_id
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