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Study of Bevacizumab, Erlotinib, FOLFOX for Patients With Untreated Metastatic Colorectal Cancer

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: NCT00116506
Recruitment Status : Completed
First Posted : June 30, 2005
Last Update Posted : December 21, 2007
Brigham and Women's Hospital
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Genentech, Inc.
Information provided by:
Dana-Farber Cancer Institute

Brief Summary:
Despite recent advances, most patients with advanced colorectal cancer continue to have a poor prognosis. 5-FU, leucovorin, oxaliplatin and bevacizumab is a standard treatment option for patients with stage IV colorectal cancer. Fluorouracil (5-FU), leucovorin and oxaliplatin are considered traditional chemotherapies that try to stop tumor growth by affecting how they divide. Bevacizumab is a therapy to try to block the blood vessels that tumors need to grow. It is considered a 'targeted agent'. Erlotinib is another targeted agent, that has been shown to be effective in treating lung and other cancers. This trial is assessing the potential benefit of adding these second targeted agents to standard treatment.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Neoplasm Metastasis Drug: erlotinib Drug: FOLFOX Drug: bevacizumab Phase 2

Detailed Description:
  • Patients receive bevacizumab, oxaliplatin, leucovorin, and 5-FU intravenously. The erlotinib is taken orally each day. One cycle of study therapy is 14 days. Cycles may be repeated unless there are intolerable side effects or the cancer worsens.
  • Patients will undergo a tumor measurement evaluation following 3 cycles of study therapy, and then every 4 cycles thereafter.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Bevacizumab (Avastin™) and Erlotinib (Tarceva™) in Combination With FOLFOX for Patients With Untreated Metastatic Colorectal Cancer
Study Start Date : January 2005
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Evaluate 1 year progression-free survival

Secondary Outcome Measures :
  1. Determination of the observed response rate, median duration of response and overall survival

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.

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

Inclusion Criteria:

  • Eligible patients must have histologically or cytologically documented locally advanced or metastatic colorectal cancer
  • No prior chemotherapy treatment for advanced or metastatic colorectal cancer. Patients may have received prior adjuvant chemotherapy or radiation with radiosensitizing chemotherapy. The last course of adjuvant chemotherapy must have concluded > 12 months prior to registration. Patients may not have previously received irinotecan, oxaliplatin, antiangiogenesis agent, or EGFR inhibitor therapy in either the adjuvant or metastatic setting. No concurrent use of additional investigational agents (including up to 4 weeks prior to enrollment) is allowed while participating in this study.
  • Palliative radiation for metastatic disease is allowed, however at least 4 weeks must elapse from last treatment to first cycle of therapy and patient must have fully recovered from side effects of radiation therapy.
  • Patients must have measurable disease
  • Age > 18 years.
  • ECOG Performance Score of 0-1.
  • Patients should have completed any major surgery > 4 weeks from registration. Patients must have completed any minor surgery (including CT or U/S guided biopsies) > 7 days from registration. Patients must have fully recovered from the procedure. (Insertion of a vascular access device is not considered major or minor surgery).
  • Adequate bone marrow as evidenced by: *Absolute neutrophil count > 1,500/mL; *Platelet count > 100,000/mL
  • Adequate renal function as evidenced by serum creatinine < 1.5 mg/dL
  • Adequate hepatic function as evidenced by: *Serum total bilirubin < 1.5 mg/dL; *Alkaline phosphatase < 3X the ULN (< 5X the ULN for patients with known hepatic metastases);

    • SGOT/SGPT < 3X the ULN (< 5X the ULN for patients with known hepatic metastases)
  • Patients of childbearing potential and their partners must agree to use an effective form of contraception during the study and for 90 days following the last dose of study medication.

Exclusion Criteria:

  • Patients with an active infection or with a fever within 3 days of the first scheduled day of protocol treatment.
  • Presence of central nervous system or brain metastases.
  • History of prior malignancy within the past 5 years except for curatively treated basal cell carcinoma of the skin, cervical intra-epithelial neoplasia, or treated localized prostate cancer with a current PSA of < 1.0 mg/dL on 2 successive evaluations, at least 3 months apart, with the most recent evaluation no more than 4 weeks prior to entry.
  • Patients with known hypersensitivity to any of the components of oxaliplatin, 5-fluorouracil (or other fluoropyrimidines), leucovorin, bevacizumab or erlotinib.
  • Peripheral neuropathy > Grade 2.
  • Patients who are pregnant or lactating.
  • Any other medical condition, including mental illness or substance abuse, deemed by the clinician to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.
  • History of allogeneic transplant.
  • Known HIV or Hepatitis B or C
  • Inadequately controlled hypertension
  • Unstable angina or New York Heart Association (NYHA) Grade II or greater congestive heart failure.
  • History of myocardial infarction within 6 months.
  • History of stroke within 6 months.
  • Clinically significant peripheral vascular disease.
  • Evidence of bleeding diathesis or coagulopathy.
  • Urine protein:creatinine ratio ≥ 1.0 at screening.
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0.
  • Serious, non-healing wound, ulcer, or bone fracture.
  • Patients lacking physical integrity of the upper gastrointestinal tract or who have malabsorption syndrome.

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): NCT00116506

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United States, Massachusetts
Massachusett General Hospital
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Genentech, Inc.
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Principal Investigator: Jeffrey Meyerhardt, MD Dana-Farber Cancer Institute
Layout table for additonal information Identifier: NCT00116506    
Other Study ID Numbers: 04-365
First Posted: June 30, 2005    Key Record Dates
Last Update Posted: December 21, 2007
Last Verified: December 2007
Keywords provided by Dana-Farber Cancer Institute:
Metastatic Colorectal Cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Neoplasm Metastasis
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Erlotinib Hydrochloride
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action