CLINICAL STUDY PHASE II, RANDOMIZED, OF THREE BRANCHES OF IROFULVEN / PREDNISONE, IROFULVEN / CAPECITABINE / PREDNISONE OR MITOXANTRONE / PREDNISONE IN PATIENTS WITH HORMONE-REFRACTORY PROSTATE CANCER PREVIOUSLY TREATED WITH DOCETAXE

Not Applicable

• Conditions: -C61 Malignant neoplasm of prostate; Malignant neoplasm of prostate; C61

• Registration Number: PER-039-04
• Lead Sponsor: MGI PHARMA, INC.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2004-07-09
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion 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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:RECIST criteria<br>Measure:Time to progression: RECIST criteria (Criteria for evaluating the response in solid tumors)<br>Timepoints:Between randomization and interruption of the study or progression of the disease, whichever occurs later.<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:objective response rate and PSA response rate according to RECIST and PSAWGR criteria, respectively.<br>Measure:Efficacy: Overall survival; objective response rate and PSA response rate according to RECIST and PSAWGR criteria, respectively.<br>Timepoints:Between randomization and death.<br>