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Study of Irofulven in Patients With Hormone-refractory Prostate Cancer

Information source: Eisai Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prostate Cancer

Intervention: Irofulven + prednisone (Drug); Irofulven + capecitabine + prednisone (Drug); Mitoxantrone + prednisone (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Eisai Inc.


The purpose of this study is to assess the efficacy and safety of irofulven-based regimens compared to mitoxantrone plus prednisone in patients with hormone-refractory prostate cancer (HRPC) whose disease has progressed following Taxotere based regimens.

Clinical Details

Official title: 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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Time to progression: RECIST (Response Evaluation Criteria in Solid Tumors) criteria

Time to progression: Prostate-specific antigen (PSA) evolution (Prostate-Specific Antigen Working Group Recommendations [PSAWGR criteria]).

Secondary outcome:

Efficacy: Overall survival; objective response rate and PSA response rate according to RECIST and PSAWGR criteria, respectively.

Determine safety profile of each treatment arm: incidence and severity of adverse events (AEs), serious AEs, and laboratory abnormalities.

Assess pain response in patients with significant pain at baseline using Tannock criteria and McGill-Melzack Pain Questionnaire.

Quality of life (QOL) as measured by the Prostate Cancer Specific Quality of Life Instrument (PROSQOLI).

Detailed description: For every five patients randomized, two will receive treatment number 1 (irofulven + prednisone), two patients will receive treatment number 2 (irofulven + capecitabine (Xeloda«) + prednisone), and one patient will receive treatment number 3 (mitoxantrone + prednisone). This is not a blinded study, so both the patient and doctor will know which treatment has been assigned.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.


Inclusion Criteria: To be included in the study, patients must meet the following 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: Patients cannot participate in the study if any of the following apply: 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. 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.

Locations and Contacts

Belo Horizonte, Brazil

Porto Alegre, Brazil

Rio de Janeiro, Brazil

Santiago, Chile

Zagreb, Croatia

Avignon, France

Orleans, France

Paris, France

Saint-Brieuc, France

Saint-Gregoire, France

Lima, Peru

Bucharest, Romania

Cluj-Napoca, Romania

Arkhangelsk, Russian Federation

Chelyabinsk, Russian Federation

Moscow, Russian Federation

Calgary, Alberta, Canada

Hot Springs, Arkansas, United States

Jonesboro, Arkansas, United States

Vancouver, British Columbia, Canada

Greenbrae, California, United States

Colorado Springs, Colorado, United States

Bonita Springs, Florida, United States

Bradenton, Florida, United States

Cape Coral, Florida, United States

Ft. 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

Winnipeg, Manitoba, Canada

Minneapolis, Minnesota, United States

Billings, Montana, United States

Albany, New York, United States

East Setauket, New York, United States

Kettering, Ohio, United States

London, Ontario, Canada

Montreal, Quebec, Canada

Greenville, South Carolina, United States

Nashville, Tennessee, United States

Dallas, Texas, United States

Ft. Worth, Texas, United States

Tyler, Texas, United States

Spokane, Washington, United States

Marshfield, Wisconsin, United States

Additional Information

Starting date: June 2004
Last updated: August 27, 2009

Page last updated: August 23, 2015

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