Study of Capecitabine and Cetuximab as First-Line Therapy in Patients With Metastatic Wild Type Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Colorectal Cancer
NCT ID: NCT00954876
Last Updated: 2022-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2009-08-31
2010-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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capecitabine and cetuximab
Cetuximab 500 mg/m2 IV infusion over 1-2 hours Once every 2 weeks
Capecitabine 1500 mg/m2 PO BID Days 1-7 followed by 7 days of no treatment and repeated every 2 weeks
Eligibility Criteria
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Inclusion Criteria
* Tumor classified WT KRAS
* At least 18 yrs of age
* ECOG PS 0,1 or 2
* Evidence of adequate organ function
* Measurable disease per RECIST criteria
* Have at least two of the following criteria:
* Age \> 65 years
* ECOG PS 1 or 2
* Serum Albumin \< or equal to 3.5g/dL
* Prior RT to abdomen or pelvis
* Stopped first-line combination systemic chemotherapy \< 6 weeks duration
Exclusion Criteria
* Prior therapy with cetuximab, panitumumab or other agent that targets EGFR
* Prior exposure to any biologic
* Known sensitivity to cetuximab or 5-FU (or marked intolerance to 5-FU)
* Known DPD deficiency
* Uncontrolled angina or a myocardial infarction within the previous 12 months
* Concurrent severe uncontrolled medical illness
* Known uncontrolled CNS metastases
* Bowel disease associated with chronic diarrhea
* Major surgery within 28 days
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Translational Genomics Research Institute
OTHER
Responsible Party
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Principal Investigators
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Ramesh Ramanathan, M.D.
Role: PRINCIPAL_INVESTIGATOR
Translational Genomics
Locations
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Evergreen Hematology & Oncology
Spokane, Washington, United States
Countries
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Other Identifiers
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MED-P02-07003
Identifier Type: -
Identifier Source: org_study_id
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