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Study of Irofulven in Patients With Hormone-Refractory Prostate Cancer
This study is ongoing, but not recruiting participants.
Sponsored by: Eisai Medical Research Inc.
Information provided by: Eisai Medical Research Inc.
ClinicalTrials.gov Identifier: NCT00124566
  Purpose

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

MedlinePlus related topics: Cancer Prostate Cancer
Drug Information available for: Mitoxantrone hydrochloride Mitoxantrone Prednisone Docetaxel Capecitabine 6-(Hydroxymethyl)acylfulvene
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Eisai Medical Research Inc.:

Primary Outcome Measures:
  • Time to progression
  • Prostate specific antigen (PSA) and objective response assessment
  • Overall survival

Secondary Outcome Measures:
  • Determine safety profile of each treatment arm
  • Assess pain response in patients with significant pain at baseline
  • Quality of life (QOL)

Estimated Enrollment: 135
Study Start Date: June 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00124566

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Sponsors and Collaborators
Eisai Medical Research Inc.
  More Information

Study ID Numbers: IROF-018
Study First Received: July 26, 2005
Last Updated: February 15, 2006
ClinicalTrials.gov Identifier: NCT00124566  
Health Authority: United States: Food and Drug Administration

Keywords provided by Eisai Medical Research Inc.:
Irofulven
Docetaxel
Taxotere

Study placed in the following topic categories:
Docetaxel
Prednisone
Capecitabine
Prostatic Diseases
Genital Neoplasms, Male
Irofulven
Urogenital Neoplasms
Mitoxantrone
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:
Antimetabolites
Anti-Inflammatory Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Glucocorticoids
Hormones
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Sensory System Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Analgesics
Peripheral Nervous System Agents
Alkylating Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009