Clinical trial NCT00124566: Study of Irofulven in Patients With Hormone-refractory Prostate Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Irofulven
Docetaxel
Taxotere
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2005-07-28
Enrollment: 135
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time to progression: RECIST (Response Evaluation Criteria in Solid Tumors) criteria
timeFrame: Between randomization and study discontinuation or disease progression, whichever occurs later.
measure: Time to progression: Prostate-specific antigen (PSA) evolution (Prostate-Specific Antigen Working Group Recommendations [PSAWGR criteria]).
timeFrame: Between randomization and study discontinuation or disease progression, whichever occurs later.
Secondary outcomes:
measure: Efficacy: Overall survival; objective response rate and PSA response rate according to RECIST and PSAWGR criteria, respectively.
timeFrame: Between randomization and death.
measure: Determine safety profile of each treatment arm: incidence and severity of adverse events (AEs), serious AEs, and laboratory abnormalities.
timeFrame: Between randomization until a minimum of 30 days after last dose of study drug; treatment-related AEs will be followed until resolution.
measure: Assess pain response in patients with significant pain at baseline using Tannock criteria and McGill-Melzack Pain Questionnaire.
timeFrame: Seven days prior to randomization and prior to each new cycle of study drug administration.
measure: Quality of life (QOL) as measured by the Prostate Cancer Specific Quality of Life Instrument (PROSQOLI).
timeFrame: Between baseline and study drug discontinuation.
Other outcomes:
Locations:
city: Hot Springs
country: United States
state: Arkansas
city: Jonesboro
country: United States
state: Arkansas
city: Greenbrae
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: Bonita Springs
country: United States
state: Florida
city: Bradenton
country: United States
state: Florida
city: Cape Coral
country: United States
state: Florida
city: Ft. Meyers
country: United States
state: Florida
city: Naples
country: United States
state: Florida
city: Port Charlotte
country: United States
state: Florida
city: Sarasota
country: United States
state: Florida
city: Venice
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Augusta
country: United States
state: Georgia
city: Macon
country: United States
state: Georgia
city: Marietta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Minneapolis
country: United States
state: Minnesota
city: Billings
country: United States
state: Montana
city: Albany
country: United States
state: New York
city: East Setauket
country: United States
state: New York
city: Kettering
country: United States
state: Ohio
city: Greenville
country: United States
state: South Carolina
city: Nashville
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Ft. Worth
country: United States
state: Texas
city: Tyler
country: United States
state: Texas
city: Spokane
country: United States
state: Washington
city: Marshfield
country: United States
state: Wisconsin
city: Belo Horizonte
country: Brazil
city: Porto Alegre
country: Brazil
city: Rio de Janeiro
country: Brazil
city: Calgary
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: Winnipeg
country: Canada
state: Manitoba
city: London
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Santiago
country: Chile
city: Zagreb
country: Croatia
city: Avignon
country: France
city: Orleans
country: France
city: Paris
country: France
city: Saint-Brieuc
country: France
city: Saint-Gregoire
country: France
city: Lima
country: Peru
city: Bucharest
country: Romania
city: Cluj-Napoca
country: Romania
city: Arkhangelsk
country: Russian Federation
city: Chelyabinsk
country: Russian Federation
city: Moscow
country: Russian Federation
Study officials:
References: