Irofulven is an investigational chemotherapeutic agent being studied in a variety of solid tumors. 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. Upon determination of eligibility, patients will randomly be assigned to receive one of three treatment arms:

• Irofulven + prednisone

• Irofulven + capecitabine (Xeloda®) + prednisone

• Mitoxantrone + prednisone

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.

Condition	Intervention	Phase
Prostate Cancer	Drug: Irofulven + prednisone  Drug: Irofulven + capecitabine + prednisone  Drug: Mitoxantrone + prednisone	Phase II

Further Study Details: 

Primary Outcomes: Time to progression; PSA and objective response assessment; Overall survival
Secondary Outcomes: Determine safety profile of each treatment arm.; Assess pain response in patients with significant pain at baseline.; Quality of Life (QOL)
Expected Total Enrollment:  135

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Male

Criteria

Inclusion Criteria

To be included in the study, you 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 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

You cannot participate in the study if any of the following apply to you:

• Unable to use prednisone.
• Prior treatment with irofulven, capecitabine (Xeloda®), continuous/ protracted infusion 5-FU (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 bisphosphonates agents (e.g. pamidronate, etidronate) within 2 months of entering the study. Pre-existing treatment with bisphosphonates 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 you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have. You can then decide if you wish to participate.

Please refer to this study by ClinicalTrials.gov identifier  NCT00124566

MGI PHARMA, INC. Medical Communications      1-800-562-5580    druginfo@mgipharma.com

Arkansas
      Hot Springs,  Arkansas,  United States; Recruiting
      Jonesboro,  Arkansas,  United States; Recruiting
California
      Greenbrae,  California,  United States; Recruiting
Colorado
      Colorado Springs,  Colorado,  United States; Not yet recruiting
Florida
      Bonita Springs,  Florida,  United States; Recruiting
      Bradenton,  Florida,  United States; Recruiting
      Cape Coral,  Florida,  United States; Recruiting
      Ft. Meyers,  Florida,  United States; Recruiting
      Naples,  Florida,  United States; Recruiting
      Ocoee,  Florida,  United States; Recruiting
      Port Charlotte,  Florida,  United States; Recruiting
      Sarasota,  Florida,  United States; Recruiting
      Venice,  Florida,  United States; Recruiting
Georgia
      Augusta,  Georgia,  United States; Recruiting
      Macon,  Georgia,  United States; Recruiting
      Marietta,  Georgia,  United States; Recruiting
      Atlanta,  Georgia,  United States; Not yet recruiting
Illinois
      Chicago,  Illinois,  United States; Recruiting
Minnesota
      Minneapolis,  Minnesota,  United States; Recruiting
Montana
      Billings,  Montana,  United States; Recruiting
New York
      Albany,  New York,  United States; Recruiting
      East Setauket,  New York,  United States; Recruiting
Ohio
      Kettering,  Ohio,  United States; Recruiting
South Carolina
      Greenville,  South Carolina,  United States; Recruiting
Tennessee
      Nashville,  Tennessee,  United States; Recruiting
Texas
      Dallas,  Texas,  United States; Recruiting
      Ft. Worth,  Texas,  United States; Recruiting
      Tyler,  Texas,  United States; Recruiting
Washington
      Spokane,  Washington,  United States; Recruiting
Wisconsin
      Marshfield,  Wisconsin,  United States; Recruiting
Brazil
      Belo Horizonte,  Brazil; Recruiting
      Porto Alegre,  Brazil; Recruiting
      Rio de Janeiro,  Brazil; Recruiting
Canada, Alberta
      Calgary,  Alberta,  Canada; Recruiting
Canada, British Columbia
      Vancouver,  British Columbia,  Canada; Recruiting
Canada, Manitoba
      Winnipeg,  Manitoba,  Canada; Recruiting
Canada, Ontario
      London,  Ontario,  Canada; Recruiting
Chile
      Santiago,  Chile; Recruiting
Croatia
      Zagreb,  Croatia; Recruiting
France
      Avignon,  France; Recruiting
      Orleans,  France; Recruiting
      Paris,  France; Recruiting
      Saint-Brieuc,  France; Recruiting
      Saint-Gregoire,  France; Recruiting
Peru
      Lima,  Peru; Recruiting
Romania
      Bucarest,  Romania; Recruiting
      Cluj Napoca,  Romania; Recruiting
Russian Federation
      Arkhangelsk,  Russian Federation; Recruiting
      Chelyabinsk,  Russian Federation; Recruiting
      Moscow,  Russian Federation; Recruiting

Study ID Numbers:  IROF-018
Last Updated:  August 1, 2005
Record first received:  July 27, 2005
ClinicalTrials.gov Identifier:  NCT00124566
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-02