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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00321100
Recruitment Status : Terminated (Enrollment closed 10/15/2008 based on data about KRAS.)
First Posted : May 3, 2006
Last Update Posted : May 7, 2014
Information provided by (Responsible Party):
Fox Chase Cancer Center

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 oxaliplatin with out without bevacizumab.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Drug: bevacizumab Drug: Cetuximab Drug: Oxaliplatin Drug: Capecitabine Phase 2

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 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of the Combination of Cetuximab, Capecitabine, and Oxaliplatin With Out Without Bevacizumab as Initial Therapy for Metastatic Colorectal Cancer
Study Start Date : April 2006
Actual Primary Completion Date : April 2009
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: A
Cetuximab 250mg/m2 IVweekly of each 21 day cycle; Oxaliplatin 130mg/m2 IVday 1 of each 21 day cycle; Capecitabine 850mg/m2 PO days 1-14 of each 21 day cycle; Bevacizumab 7.5mg/kg IV day 1 of each 21 day cycle
Drug: bevacizumab
Bevacizumab 7.5mg/kg IV day 1 of each 21 day cycle
Other Name: Avastin
Drug: Cetuximab
Cetuximab 250mg/m2 IV weekly each 21 day cycle
Drug: Oxaliplatin
Oxaliplatin 130mg/m2 IV day 1 every 21 days
Drug: Capecitabine
Capecitabine 850mg/m2 PO every 12 hours days 1-14 of each 21 day cycle
Other Name: Xeloda
Active Comparator: B
Cetuximab 250mg/m2 IV weekly for each 21 day cycle
Drug: Cetuximab
Cetuximab 250mg/m2 IV weekly each 21 day cycle

Primary Outcome Measures :
  1. Determine the objective response rate using RESIST criteria after every second cycle [ Time Frame: every 6-9 weeks ]

Secondary Outcome Measures :
  1. Determine time to progression [ Time Frame: every 6-9 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 </= 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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00321100

United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Sponsors and Collaborators
Fox Chase Cancer Center
Principal Investigator: Steven Cohen, MD Fox Chase Cancer Center

Publications of Results:
Responsible Party: Fox Chase Cancer Center Identifier: NCT00321100     History of Changes
Other Study ID Numbers: FER-GI-002
First Posted: May 3, 2006    Key Record Dates
Last Update Posted: May 7, 2014
Last Verified: May 2014

Keywords provided by Fox Chase Cancer Center:
initial therapy

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action