Study of Irofulven in Patients With Hormone-Refractory Prostate Cancer

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: MGI PHARMA, Inc.

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.

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: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Time to progression

Prostate specific antigen (PSA) and objective response assessment

Overall survival

Secondary outcome:

Determine safety profile of each treatment arm

Assess pain response in patients with significant pain at baseline

Quality of life (QOL)

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

Criteria:

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.

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

Bucarest, 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

Augusta, Georgia, United States

Macon, Georgia, United States

Marietta, Georgia, United States

Atlanta, 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

Starting date: June 2004
Last updated: February 15, 2006