Study of Irofulven in Patients With Hormone-refractory Prostate Cancer

NCT00124566 | Completed Phase 2

• 1 other identifier: IROF-018
• Study Type: interventional
• Target: 135
• Locations: 9 countries
• Sites: 50

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

Irofulven; Docetaxel; Taxotere

Outcome Measures

Primary Outcomes (2)

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

  Between randomization and study discontinuation or disease progression, whichever occurs later.

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

  Between randomization and study discontinuation or disease progression, whichever occurs later.

Secondary Outcomes (4)

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

  Between randomization and death.

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

  Between randomization until a minimum of 30 days after last dose of study drug; treatment-related AEs will be followed until resolution.

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

  Seven days prior to randomization and prior to each new cycle of study drug administration.

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

  Between baseline and study drug discontinuation.

Study Arms (3)

1

EXPERIMENTAL

Irofulven + prednisone

Drug: Irofulven; Drug: Prednisone

2

EXPERIMENTAL

Irofulven + capecitabine + prednisone

Drug: Prednisone; Drug: Capecitabine; Drug: Irofulven

3

ACTIVE COMPARATOR

Mitoxantrone + prednisone

Drug: Prednisone; Drug: Mitoxantrone

Interventions

Irofulven DRUG

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.

1

Prednisone DRUG

Subjects will also receive oral prednisone at a dose of 10 mg per day in the morning.

1; 2; 3

Mitoxantrone DRUG

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.

3

Capecitabine DRUG

Subjects will receive oral capecitabine at a dose of 1000 mg/m\^2 twice daily for 15 days every 28 days.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be included in the study, patients must meet the following criteria:
• Cancer of the prostate confirmed by a biopsy sample.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (50)

Unknown Facility

Hot Springs, Arkansas, United States

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Jonesboro, Arkansas, United States

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Greenbrae, California, United States

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Colorado Springs, Colorado, United States

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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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Fort 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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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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Chicago, Illinois, United States

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Minneapolis, Minnesota, United States

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Billings, Montana, United States

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Albany, New York, United States

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East Setauket, New York, United States

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Kettering, Ohio, United States

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Greenville, South Carolina, United States

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Nashville, Tennessee, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Tyler, Texas, United States

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Spokane, Washington, United States

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Marshfield, Wisconsin, United States

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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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Calgary, Alberta, Canada

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Vancouver, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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London, Ontario, Canada

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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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Orléans, France

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Paris, France

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Saint-Brieuc, France

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Saint-Grégoire, 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, Russia

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Chelyabinsk, Russia

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Moscow, Russia

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MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

irofulven; Prednisone; Mitoxantrone; Capecitabine

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Anthraquinones; Anthrones; Anthracenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Quinones; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 26, 2005
• First Posted: July 28, 2005
• Study Start: June 1, 2004
• Primary Completion: January 1, 2006
• Study Completion: December 1, 2009
• Last Updated: January 18, 2016

Record last verified: 2016-01

Locations

CL (1); BR (3); FR (5); CA (5); RO (2); RU (3); US (29); PE (1); CR (1)