Prostate Cancer
Conditions
Keywords
Irofulven, Docetaxel, Taxotere
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 disease has progressed following Taxotere based regimens.
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.
Interventions
DRUGIrofulven
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.
DRUGPrednisone
Subjects will also receive oral prednisone at a dose of 10 mg per day in the morning.
DRUGMitoxantrone
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.
DRUGCapecitabine
Subjects will receive oral capecitabine at a dose of 1000 mg/m\^2 twice daily for 15 days every 28 days.
Sponsors
Eisai Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to progression: RECIST (Response Evaluation Criteria in Solid Tumors) criteria | 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]). | Between randomization and study discontinuation or disease progression, whichever occurs later. |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: Overall survival; objective response rate and PSA response rate according to RECIST and PSAWGR criteria, respectively. | Between randomization and death. |
| Determine safety profile of each treatment arm: incidence and severity of adverse events (AEs), serious AEs, and laboratory abnormalities. | 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. | 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). | Between baseline and study drug discontinuation. |
Countries
Brazil, Canada, Chile, Croatia, France, Peru, Romania, Russia, United States
Outcome results
None listed