Status:
TERMINATED
Combination of Cetuximab, Capecitabine, and Oxaliplatin With or Without Bevacizumab
Lead Sponsor:
Fox Chase Cancer Center
Conditions:
Colorectal Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the objective response rate of patients with previously untreated metastatic colorectal cancer treated with the combination of cetuximab, capecitabine, and ox...
Detailed Description
Research has shown that the more drug treatments patients with cancer of the colon or rectum receive, the longer they live. One uses the drugs capecitabine and oxaliplatin which all patients on this s...
Eligibility Criteria
Inclusion
- measurable metastatic adenocarcinoma of the colon or rectum
- no prior systemic therapy for metastatic disease
- adjuvant therapy must have been completed \>/=12 months prior to recurrence, prior radiotherapy permitted but must have been completed \> 6 months prior to study entry
- must have tumor tissue available for EGFR and thymidine phosphorylase evaluation
- ECOG PS 0-1
- age \>/= 18
- adequate organ function: WBC\>/=3,000, ANC \>/=1,500, platelets\>/= 100,000, total bilirubin \</= 1.5X ULN, AST\&ALT \</= 2.5X ULN, create clearance \>/= 50mL/min
- negative pregnancy test w/in 72 hours of treatment for women of child bearing potential
- ability to understand and willing to sign written ICF
- able to swallow and absorb oral medication
Exclusion
- medical or psychiatric condition which would potentially pose risk to patient by participation (i.e. but not limited to:uncontrolled hypertension, MI w/in 6 months,CNS disease, pregnancy or nursing)
- history of neoplasm (other than non-metastatic skin cancer or carcinoma in situ of cervix) w/in 5 years
- surgical procedure (not including closed biopsy or access port placement), open biopsy, significant traumatic injury w/in 28 days of registration or anticipation of need for surgical procedure while on study, fine needle aspiration or core biopsy w/in 7 days of registration
- urine protein:creatinine ration \>/=1.0 at screening
- evidence of bleeding diathesis or coagulopathy (in absence of anticoagulation)
- prior severe infusion reaction to MAB or allergic reaction to capecitabine or oxaliplatin
- underlying neuropathy \>/= grade 2
- TIA or CVA w/in 6 months
Key Trial Info
Start Date :
April 12 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 18 2013
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00321100
Start Date
April 12 2006
End Date
December 18 2013
Last Update
January 12 2022
Active Locations (1)
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1
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111