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Sponsored by: |
University of California, Davis |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00376727 |
RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.
PURPOSE: This phase I trial is studying the side effects and best dose of cetuximab in treating patients with advanced solid tumors.
Condition | Intervention | Phase |
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Unspecified Adult Solid Tumor, Protocol Specific |
Drug: cetuximab Procedure: immunologic technique Procedure: laboratory biomarker analysis Procedure: molecular diagnostic method |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase I Study of the Safety and Tolerability of Four Doses of Cetuximab (C225) in Patients With Advanced Solid Tumors |
Estimated Enrollment: | 20 |
Study Start Date: | December 2004 |
Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, dose-escalation study.
Patients receive cetuximab IV over 90 minutes once weekly for 4 weeks. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of cetuximab until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.
Patients undergo blood and buccal mucosa collection at baseline and prior to courses 2 and 3 of treatment for molecular correlative studies. Archival tumor tissue specimens are also used for molecular correlative studies. Immunologic correlative studies are performed using patient blood samples.
After completion of study treatment, patients are followed periodically for survival.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed advanced solid tumor
Asymptomatic brain metastases treated by surgical resection or radiotherapy allowed provided patient is neurologically stable and has been off steroids for ≥ 4 weeks
Archival tumor tissue (i.e., paraffin block or ≥ 3 unstained slides) available
PATIENT CHARACTERISTICS:
No uncontrolled intercurrent illness including, but not limited to, the following:
PRIOR CONCURRENT THERAPY:
No other prior drug that targets the EGFR including, but not limited to, the following:
United States, California | |
University of California Davis Cancer Center | |
Sacramento, California, United States, 95817 |
Study Chair: | Angela Davies, MD | University of California, Davis |
Investigator: | Corinne Turrell, CCRP | University of California, Davis |
Study ID Numbers: | CDR0000506089, UCDCC-165, BMS-CA225027, UCDCC-200412499-3, IMCL-8420 |
Study First Received: | September 13, 2006 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00376727 |
Health Authority: | United States: Food and Drug Administration |
unspecified adult solid tumor, protocol specific |
Cetuximab |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |