OSI-7904L and Oxaliplatin in Treating Patients With Refractory or Recurrent Advanced Colorectal Cancer
Recruitment status was Active, not recruiting
Tracking Information | |||||
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First Received Date ICMJE | April 7, 2004 | ||||
Last Updated Date | July 23, 2008 | ||||
Start Date ICMJE | February 2004 | ||||
Primary Completion Date | |||||
Current Primary Outcome Measures ICMJE |
Maximum tolerated dose and recommended dose for future trials as measured by CTC v3.0 [ Designated as safety issue: Yes ] | ||||
Original Primary Outcome Measures ICMJE |
Maximum tolerated dose and recommended dose for future trials as measured by CTC v3.0 | ||||
Change History | Complete list of historical versions of study NCT00081237 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | OSI-7904L and Oxaliplatin in Treating Patients With Refractory or Recurrent Advanced Colorectal Cancer | ||||
Official Title ICMJE | A Phase I Study of OSI-7904L In Combination With Oxaliplatin In Patients With Advanced Colo-Rectal Cancer | ||||
Brief Summary | RATIONALE: OSI-7904L may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining OSI-7904L with oxaliplatin may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of OSI-7904L and oxaliplatin in treating patients with refractory or recurrent advanced colorectal cancer. |
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Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: This is a nonrandomized, multicenter, open-label, dose-escalation study. Patients receive oxaliplatin IV over 2 hours followed by OSI-7904L IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of OSI-7904L and oxaliplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. A maximum of 12 patients receive treatment at the MTD. Patients are followed every 8 weeks. PROJECTED ACCRUAL: A total of 3-25 patients will be accrued for this study. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 1 | ||||
Study Design ICMJE | Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Colorectal Cancer | ||||
Intervention ICMJE |
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Study Arm (s) | |||||
Publications * | Clamp AR, Schöffski P, Valle JW, Wilson RH, Marreaud S, Govaerts AS, Debois M, Lacombe D, Twelves C, Chick J, Jayson GC; EORTC New Drug Development Group. A phase I and pharmacokinetic study of OSI-7904L, a liposomal thymidylate synthase inhibitor in combination with oxaliplatin in patients with advanced colorectal cancer. Cancer Chemother Pharmacol. 2008 Apr;61(4):579-85. Epub 2007 May 23. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Enrollment ICMJE | |||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | Germany, United Kingdom | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00081237 | ||||
Other Study ID Numbers ICMJE | CDR0000360667, EORTC-16033, OSI-EORTC-16033 | ||||
Has Data Monitoring Committee | |||||
Responsible Party | |||||
Study Sponsor ICMJE | European Organization for Research and Treatment of Cancer - EORTC | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | National Cancer Institute (NCI) | ||||
Verification Date | September 2005 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |