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Sponsored by: |
Eisai Medical Research Inc. |
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Information provided by: | Eisai Medical Research Inc. |
ClinicalTrials.gov Identifier: | NCT00124566 |
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:
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 |
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Prostate Cancer |
Drug: Irofulven + prednisone Drug: Irofulven + capecitabine + prednisone Drug: Mitoxantrone + prednisone |
Phase II |
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 |
Estimated Enrollment: | 135 |
Study Start Date: | June 2004 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
To be included in the study, patients must meet the following criteria:
Exclusion Criteria
Patients cannot participate in the study if any of the following apply:
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.
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 |
Irofulven Docetaxel Taxotere |
Docetaxel Prednisone Capecitabine Prostatic Diseases Genital Neoplasms, Male |
Irofulven Urogenital Neoplasms Mitoxantrone Genital Diseases, Male Prostatic Neoplasms |
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 |