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A Randomized Phase II Study of Modified FOLFOX6 (Infusional 5-Fluorouracil/Leucovorin, Oxaliplatin) and Bevacizumab With or Without Cetuximab in Patients With Metastatic Colorectal Cancer

Phase 2
18 Years
Not Enrolling
Colon Cancer

Thank you

Trial Information

A Randomized Phase II Study of Modified FOLFOX6 (Infusional 5-Fluorouracil/Leucovorin, Oxaliplatin) and Bevacizumab With or Without Cetuximab in Patients With Metastatic Colorectal Cancer

All patients received cetuximab: 400 mg/m2 (first cycle only) administered intravenously
(IV) on day 1 and 250 mg/m2 IV on day 8 with all subsequent cycles 250 mg/m2 IV on days 1
and 8. Day 1 cetuximab was immediately followed by bevacizumab 5 mg/kg IV, oxaliplatin 85
mg/m2 IV, and 5-fluorouracil 400 mg/m2 IV bolus, followed by 2400 mg/m2 administered as a
continuous infusion over 46 hours via a pump (outpatient) and leucovorin 350 mg IV (modified
FOLFOX6). Cycles were 14 days.

Inclusion Criteria:

To be included in the study, you must meet the following criteria:

- Metastatic colorectal cancer confirmed by a biopsy sample

- 18 years of age or older

- Evidence of disease progression at time of study entry

- At least one prior adjuvant chemotherapy regimen

- No prior therapy for metastatic disease

- Measurable disease

- Able to perform activities of daily living with minimal assistance

- Adequate bone marrow, kidney, and liver function

- Tumor tissue available for assessment of EGFR

- Signed informed consent

Exclusion Criteria:

You cannot participate in the study if any of the following apply to you:

- Treatment with a previous regimen for metastatic disease

- Prior treatment with any EGFR inhibitor or anti-angiogenic agents

- Brain or nervous system metastases

- History of severe thromboembolic event

- Clinical evidence or history of bleeding or coagulopathy

- History of stroke or heart attack within six months

- Poorly controlled hypertension

- Non-healing wound, ulcer, or bone fracture

- History of abdominal fistula, perforation, or abscess within six months

- Other uncontrolled or significant disease or medical condition

Please note: There are additional inclusion/exclusion criteria. The study center will
determine if you meet all of the criteria. If you do not qualify for the trial, study
personnel will explain the reasons. If you do qualify, study personnel will explain the
trial in detail and answer any questions you may have. You can then decide if you wish to

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment

Outcome Description:

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Outcome Time Frame:

18 months

Safety Issue:


Principal Investigator

David R. Spigel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sarah Cannon Research Institute


United States: Institutional Review Board

Study ID:




Start Date:

July 2005

Completion Date:

July 2010

Related Keywords:

  • Colon Cancer
  • Colon Cancer
  • Colonic Neoplasms
  • Colorectal Neoplasms



Consultants in Blood Disorders and Cancer Louisville, Kentucky  40207
Methodist Cancer Center Omaha, Nebraska  68114
Center for Cancer and Blood Disorders Bethesda, Maryland  20817
Mercy Hospital Portland, Maine  04101
Chattanooga Oncology and Hematology Associates Chattanooga, Tennessee  37404
St. Louis Cancer Care Chesterfield, Missouri  63017
Jackson Oncology Associates Jackson, Mississippi  39202
Tennessee Oncology Nashville, Tennessee  37203
Oncology Hematology Care Cincinnati, Ohio  45242
Oncology Hematology Associates of SW Indiana Evansville, Indiana  47714