Status:
COMPLETED
Study of Irofulven in Patients With Hormone-refractory Prostate Cancer
Lead Sponsor:
Eisai Inc.
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
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 dis...
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 on...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT00124566
Start Date
June 1 2004
End Date
December 1 2009
Last Update
January 18 2016
Active Locations (50)
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1
Hot Springs, Arkansas, United States
2
Jonesboro, Arkansas, United States
3
Greenbrae, California, United States
4
Colorado Springs, Colorado, United States