- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00374660
Study of Irofulven in Combination With Oxaliplatin in Patients With Advanced Solid Tumors
November 24, 2021 updated by: Eisai Inc.
Phase I-II Clinical and Pharmacokinetic Study of Irofulven in Combination With Oxaliplatin in Patients With Advanced Solid Tumors
The purpose of this study is to determine the maximum tolerated dose (MTD) and to investigate the efficacy, safety and pharmacokinetics of irofulven combined with oxaliplatin in patients with advanced solid tumors.
Study Overview
Study Type
Interventional
Enrollment (Actual)
63
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Bordeaux, France
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Clichy, France
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Lyon, France
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Nice, France
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Paris, France
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Poitiers, France
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Saint Cloud, France
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Signed informed consent obtained prior to initiation of any study-specific procedures and treatment.
- Malignant solid tumor confirmed by a biopsy sample.
- Pancreatic, endometrial, gastric, and hepatocellular cancer patients that have exhausted standard treatment options.
- Measurable disease according to RECIST.
- 18 years of age or older.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): 0-1.
- Life expectancy greater than 3 months.
- Previous anticancer treatment must be discontinued at least 4 weeks prior to first dose of study treatment (6 weeks for mitomycin C, 8 weeks for bicalutamide).
- Patients of reproductive age must be using effective contraceptive methods.
- Negative pregnancy test for patients of reproductive potential.
Exclusion Criteria:
- Prior therapy with irofulven or oxaliplatin.
- Patients who have had radiation therapy to more than 30% of the bone marrow prior to entry into the study.
- Prior chemotherapy with nitrosoureas or high dose carboplatin (AUC > 6), prior mitomycin C cumulative dose greater than or equal to 25 mg/m², prior bone marrow transplant or intensive chemotherapy with stem cell support.
- Presence of any serious concomitant systemic disorders incompatible with the study (e.g., uncontrolled congestive heart failure, active infection).
- Any previous history of another malignancy (other than cured basal cell carcinoma of the skin or cured in-situ carcinoma of the cervix) within 5 years of study entry, unless the active malignancy can be unmistakably identified by evidence such as recent biopsies or tumor specific markers.
- Treatment with any other investigational agent, or participation in another clinical trial within 28 days prior to study entry.
- Pregnant or lactating patients or any patient with childbearing potential not using adequate contraception.
- Patients with retinopathy or significant visual impairment not correctable by refractory lens will be enrolled on a case by case basis according to the expected benefit ratio, taking into account the malignant disease and the existence of an objective decreased visual acuity and its degree.
Please note: There are additional criteria that must be met in order to be eligible for this study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
Oxaliplatin will be administered in a 2-hour infusion on Days 1 and 15 of a 28-day cycle.
The dose levels ranged from 40 to 80 mg/m^2 by dose escalations in 10 mg/m2 increments if no dose-limiting toxicity.
Thirty minutes after completion of oxaliplatin infusion, irofulven will be administered as a 30-minute infusion on Days 1 and 15 of a 28-day cycle.
The dose levels ranged from 0.30 to 0.40 mg/kg if no dose-limiting toxicity.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Confirmed response rate: Hepatocellular Cancer (HCC) Cohort: Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
Time Frame: Every 8 weeks until progression.
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Every 8 weeks until progression.
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Hormone Refractory Prostate Cancer (HRPC) Cohort: Prostate-Specific Antigen Working Group Recommendations (PSAWGR) and RECIST criteria.
Time Frame: Every 8 weeks until progression.
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Every 8 weeks until progression.
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Efficacy: HRPC Cohort: confirmed response rate according to RECIST; progression-free survival (PFS) for progression according to RECIST; new bone lesions or skeletal events; PFS according to PSA progression; overall survival.
Time Frame: Every 8 weeks until progression.
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Every 8 weeks until progression.
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Efficacy: HCC cohort - PFS (RECIST); overall survival
Time Frame: Every 8 weeks until progression.
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Every 8 weeks until progression.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2003
Primary Completion (Actual)
April 1, 2007
Study Completion (Actual)
April 1, 2007
Study Registration Dates
First Submitted
September 8, 2006
First Submitted That Met QC Criteria
September 8, 2006
First Posted (Estimate)
September 11, 2006
Study Record Updates
Last Update Posted (Actual)
December 8, 2021
Last Update Submitted That Met QC Criteria
November 24, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IROF-017
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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