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A Phase II Study of Bevacizumab (Avastin™) and Erlotinib (Tarceva™) in Combination With FOLFOX for Patients With Untreated Metastatic Colorectal Cancer

Phase 2
18 Years
Not Enrolling
Colorectal Cancer, Neoplasm Metastasis

Thank you

Trial Information

A Phase II Study of Bevacizumab (Avastin™) and Erlotinib (Tarceva™) in Combination With FOLFOX for Patients With Untreated Metastatic Colorectal Cancer

- 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.

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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluate 1 year progression-free survival

Principal Investigator

Jeffrey Meyerhardt, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

January 2005

Completion Date:

July 2007

Related Keywords:

  • Colorectal Cancer
  • Neoplasm Metastasis
  • Metastatic Colorectal Cancer
  • Bevacizumab
  • Erlotinib
  • Neoplasms
  • Colorectal Neoplasms
  • Neoplasm Metastasis



Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusett General Hospital Boston, Massachusetts  02114