Study of Irofulven in Patients With Hormone-refractory Prostate Cancer

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00124566
• Other study ID #: IROF-018
• Status: Completed
• Phase: Phase 2
• First received: July 26, 2005
• Last updated: January 15, 2016
• Start date: June 2004
• Est. completion date: December 2009

Study information

• Verified date: January 2016
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: December 2009
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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/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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Irofulven
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.
• Prednisone
Subjects will also receive oral prednisone at a dose of 10 mg per day in the morning.
• Mitoxantrone
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.
• Capecitabine
Subjects will receive oral capecitabine at a dose of 1000 mg/m^2 twice daily for 15 days every 28 days.
• Irofulven
Subjects will receive irofulven in a 30 minute intravenous (IV) infusion at a dose of 0.4 mg/kg on Days 1 and 15 every 4 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Inc.

Countries where clinical trial is conducted

United States,  Brazil,  Canada,  Chile,  Croatia,  France,  Peru,  Romania,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to progression: RECIST (Response Evaluation Criteria in Solid Tumors) criteria		Between randomization and study discontinuation or disease progression, whichever occurs later.	No
Primary	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.	No
Secondary	Efficacy: Overall survival; objective response rate and PSA response rate according to RECIST and PSAWGR criteria, respectively.		Between randomization and death.	No
Secondary	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.	Yes
Secondary	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.	No
Secondary	Quality of life (QOL) as measured by the Prostate Cancer Specific Quality of Life Instrument (PROSQOLI).		Between baseline and study drug discontinuation.	No