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Phase II Study of the Combination of Cetuximab, Capecitabine, and Oxaliplatin With Out Without Bevacizumab as Initial Therapy for Metastatic Colorectal Cancer

Phase 2
18 Years
Not Enrolling
Colorectal Neoplasms

Thank you

Trial Information

Phase II Study of the Combination of Cetuximab, Capecitabine, and Oxaliplatin With Out Without Bevacizumab as Initial Therapy for Metastatic Colorectal Cancer

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 study will receive. Bevacizumab is an antibody which blocks blood flow to
tumors and increases how long patients with colorectal cancer live. However, it can
increase the risk of stroke and heart attack. Bevacizumab is currently a standard part of
treatment for colorectal cancer. Cetuximab is an antibody which blocks a protein called
EGFR which shrinks colorectal cancer. It may be helpful with initial chemotherapy and with
bevacizumab. One goal of this study is to find out the response rate (chance of tumor
shrinking) with two treatments for colorectal cancer. All patients will get capecitabine,
oxaliplatin and cetuximab. Half will receive bevacizumab. All drugs in this study are
approved to treat colorectal cancer. This research study is being done to find the best,
safest way to combine these therapies.

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

- 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

- underlying neuropathy >/= grade 2

- TIA or CVA w/in 6 months

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the objective response rate using RESIST criteria after every second cycle

Outcome Time Frame:

every 6-9 weeks

Safety Issue:


Principal Investigator

Steven Cohen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fox Chase Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

April 2006

Completion Date:

December 2012

Related Keywords:

  • Colorectal Neoplasms
  • metastatic
  • colorectal
  • cancer
  • initial therapy
  • Neoplasms
  • Colorectal Neoplasms



Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111