Prostate CancerPhase 2NCT00124566
Study of Irofulven in Patients With Hormone-refractory Prostate Cancer
A Phase 2 study testing Irofulven, Prednisone and Mitoxantrone in people with Prostate Cancer, run by Eisai Inc. at 50 sites in 9 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Irofulven, Prednisone and Mitoxantrone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 50 sitesin 9 countries
- Study dates
- Jun 2004to Dec 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
50 sites in 9 countries.
50 sites in 9 countries
United States29 sites
Study site
Albany, New York
Study site
Atlanta, Georgia
Study site
Augusta, Georgia
Study site
Billings, Montana
Study site
Bonita Springs, Florida
Study site
Bradenton, Florida
Study site
Cape Coral, Florida
Study site
Chicago, Illinois
Study site
Colorado Springs, Colorado
Study site
Dallas, Texas
Study site
East Setauket, New York
Study site
Fort Meyers, Florida
Study site
Fort Worth, Texas
Study site
Greenbrae, California
Study site
Greenville, South Carolina
Study site
Hot Springs, Arkansas
Study site
Jonesboro, Arkansas
Study site
Kettering, Ohio
Study site
Macon, Georgia
Study site
Marietta, Georgia
Study site
Marshfield, Wisconsin
Study site
Minneapolis, Minnesota
Study site
Naples, Florida
Study site
Nashville, Tennessee
Study site
Port Charlotte, Florida
Study site
Sarasota, Florida
Study site
Spokane, Washington
Study site
Tyler, Texas
Study site
Venice, Florida
Canada5 sites
Study site
Calgary, Alberta
Study site
London, Ontario
Study site
Montreal, Quebec
Study site
Vancouver, British Columbia
Study site
Winnipeg, Manitoba
France5 sites
Study site
Avignon
Study site
Orléans
Study site
Paris
Study site
Saint-Brieuc
Study site
Saint-Grégoire
Brazil3 sites
Study site
Belo Horizonte
Study site
Porto Alegre
Study site
Rio de Janeiro
About this study
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
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Irofulven, Prednisone, Mitoxantrone, Capecitabine
- Keywords
- Irofulven, Docetaxel, Taxotere
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IrofulvenDrug
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.
PrednisoneDrug
Subjects will also receive oral prednisone at a dose of 10 mg per day in the morning.
MitoxantroneDrug
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.
CapecitabineDrug
Subjects will receive oral capecitabine at a dose of 1000 mg/m^2 twice daily for 15 days every 28 days.
IrofulvenDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Irofulven + prednisone Receives: Drug: Irofulven; Drug: Prednisone |
| 2 | Experimental | Irofulven + capecitabine + prednisone Receives: Drug: Prednisone; Drug: Capecitabine; Drug: Irofulven |
| 3 | Active comparator | Mitoxantrone + prednisone Receives: Drug: Prednisone; Drug: Mitoxantrone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to progression: RECIST (Response Evaluation Criteria in Solid Tumors) criteria
Measured: 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]).
Measured: Between randomization and study discontinuation or disease progression, whichever occurs later.
Secondary outcomes (4)
Efficacy: Overall survival; objective response rate and PSA response rate according to RECIST and PSAWGR criteria, respectively.
Measured: Between randomization and death.
Determine safety profile of each treatment arm: incidence and severity of adverse events (AEs), serious AEs, and laboratory abnormalities.
Measured: 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.
Measured: 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).
Measured: Between baseline and study drug discontinuation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2005 (estimated)
- Study startJun 2004
- Primary completionJan 2006
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Eisai Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00124566
- Sponsor's protocol ID
- IROF-018
- Status last verified
- Jan 2016
- First submitted
- 26 Jul 2005
- Last updated
- 18 Jan 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00124566
- Acronym / sponsor ID
- IROF-018
- Conditions
- Prostate Cancer
- Keywords
- Irofulven, Docetaxel, Taxotere
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2004
- Primary completion
- Jan 2006 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 28 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Irofulven, Drug: PrednisoneIrofulven + prednisone |
| 2 | Experimental | Drug: Prednisone, Drug: Capecitabine, Drug: IrofulvenIrofulven + capecitabine + prednisone |
| 3 | Active comparator | Drug: Prednisone, Drug: MitoxantroneMitoxantrone + prednisone |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IrofulvenSubjects 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. | Drug | 1 |
| PrednisoneSubjects will also receive oral prednisone at a dose of 10 mg per day in the morning. | Drug | 1, 2, 3 |
| MitoxantroneSubjects 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. | Drug | 3 |
| CapecitabineSubjects will receive oral capecitabine at a dose of 1000 mg/m^2 twice daily for 15 days every 28 days. | Drug | 2 |
| IrofulvenSubjects 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. | Drug | 2 |
Primary outcome
Time to progression: RECIST (Response Evaluation Criteria in Solid Tumors) criteria
Time frame: 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]).
Time frame: Between randomization and study discontinuation or disease progression, whichever occurs later.
4 secondary outcomes
Efficacy: Overall survival; objective response rate and PSA response rate according to RECIST and PSAWGR criteria, respectively.
Time frame: Between randomization and death.
Determine safety profile of each treatment arm: incidence and severity of adverse events (AEs), serious AEs, and laboratory abnormalities.
Time frame: 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.
Time frame: 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).
Time frame: Between baseline and study drug discontinuation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
50 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Irofulven, Prednisone and Mitoxantrone in people with Prostate Cancer, run by Eisai Inc. at 50 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in United States, Canada, France, Brazil, Russia and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to progression: RECIST (Response Evaluation Criteria in Solid Tumors) criteria (time frame: Between randomization and study discontinuation or disease progression, whichever occurs later.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2016.