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Study of Irofulven in Patients With Hormone-refractory Prostate Cancer

This study has been completed.
Information provided by:
Eisai Inc. Identifier:
First received: July 26, 2005
Last updated: January 15, 2016
Last verified: January 2016
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.

Condition Intervention Phase
Prostate Cancer
Drug: Irofulven
Drug: Prednisone
Drug: Mitoxantrone
Drug: Capecitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Time to progression: RECIST (Response Evaluation Criteria in Solid Tumors) criteria [ Time Frame: 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]). [ Time Frame: Between randomization and study discontinuation or disease progression, whichever occurs later. ]

Secondary Outcome Measures:
  • Efficacy: Overall survival; objective response rate and PSA response rate according to RECIST and PSAWGR criteria, respectively. [ Time Frame: Between randomization and death. ]
  • Determine safety profile of each treatment arm: incidence and severity of adverse events (AEs), serious AEs, and laboratory abnormalities. [ Time Frame: 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. [ Time Frame: 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). [ Time Frame: Between baseline and study drug discontinuation. ]

Enrollment: 135
Study Start Date: June 2004
Study Completion Date: December 2009
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Irofulven + prednisone
Drug: 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.
Drug: Prednisone
Subjects will also receive oral prednisone at a dose of 10 mg per day in the morning.
Experimental: 2
Irofulven + capecitabine + prednisone
Drug: Prednisone
Subjects will also receive oral prednisone at a dose of 10 mg per day in the morning.
Drug: Capecitabine
Subjects will receive oral capecitabine at a dose of 1000 mg/m^2 twice daily for 15 days every 28 days.
Drug: 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.
Active Comparator: 3
Mitoxantrone + prednisone
Drug: Prednisone
Subjects will also receive oral prednisone at a dose of 10 mg per day in the morning.
Drug: 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.

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

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Please refer to this study by its identifier: NCT00124566

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Sponsors and Collaborators
Eisai Inc.
  More Information

Responsible Party: Eisai Medical Services, Eisai Inc. Identifier: NCT00124566     History of Changes
Other Study ID Numbers: IROF-018
Study First Received: July 26, 2005
Last Updated: January 15, 2016

Keywords provided by Eisai Inc.:

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antimetabolites, Antineoplastic
Antineoplastic Agents, Alkylating
Alkylating Agents
Sensory System Agents
Peripheral Nervous System Agents processed this record on May 23, 2017