Combination of Cetuximab, Capecitabine, and Oxaliplatin With or Without Bevacizumab

• Status: Terminated
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

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 oxaliplatin with out without bevacizumab.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fox Chase Cancer Center
• Treatments: Bevacizumab; Capecitabine; Cetuximab; Oxaliplatin

Criteria

Inclusion Criteria:

• 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/= 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 Criteria:

• 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