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Phase II Trial of FOLFOX6, Bevacizumab and Cetuximab in Patients With Colorectal Cancer

Phase 2
18 Years
Not Enrolling
Adenocarcinoma of the Rectum, Mucinous Adenocarcinoma of the Colon, Recurrent Colon Cancer, Recurrent Rectal Cancer, Signet Ring Adenocarcinoma of the Colon, Stage IVA Colon Cancer, Stage IVA Rectal Cancer, Stage IVB Colon Cancer, Stage IVB Rectal Cancer

Thank you

Trial Information

Phase II Trial of FOLFOX6, Bevacizumab and Cetuximab in Patients With Colorectal Cancer


I. To determine the safety, feasibility of administration, response rates and progression
free survival among chemotherapy naïve patients with advanced colorectal cancer treated with
Folfox 6/bevacizumab/cetuximab (FBC).

II. To determine the survival of patients with advanced colorectal cancer treated with FBC.

III. To determine the safety of the current regimen in selected patients who have had prior
MoAb therapy.

OUTLINE: This is a multicenter study.

Patients receive cetuximab IV over 60-120 minutes on day 1 in weeks 1-8. Patients also
receive bevacizumab IV over 30-90 minutes, oxaliplatin IV over 2 hours, and leucovorin
calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 48 hours on days 1
and 2 of weeks 1, 3, 5, and 7. Courses repeat every 8 weeks in the absence of disease
progression or unacceptable toxicity.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 40-67 patients will be accrued for this study.

Inclusion Criteria:

- Patients must have histologically or cytologically confirmed adenocarcinoma of the
colon or rectum which is beyond the scope of surgical resection (MEDRA
code:"Colorectal neoplasms malignant","Colorectal cancer stage IV","10010035")

- Patients must have measurable disease, defined as at least one lesion that can be
accurately measured in at least one dimension (longest diameter to be recorded) as >=
20 mm with conventional techniques or as >= 10 mm with spiral CT scan

- Patients previously treated with one chemotherapy regimen that did not include
oxaliplatin, bevacizumab or cetuximab may be enrolled to this trial

- Life expectancy of greater than 3 months

- ECOG performance status =< 1

- Leukocytes >= 3,500/uL

- Absolute neutrophil count >= 1,500/uL

- Platelets >= 150,000/uL

- Total bilirubin within normal institutional limits

- AST(SGOT)/ALT(SGPT) =< 2.5 X institutional upper limit of normal

- Creatinine within normal institutional limits

- Patients may not have received prior therapy with bevacizumab or cetuximab

- Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

- Patients who have had radiotherapy within 4 weeks prior to entering the study or
those who have not recovered from adverse events due to radiotherapy administered
more than 4 weeks earlier

- Patients may not be receiving any other investigational agents

- Patients with known brain metastases should be excluded from this clinical trial
because of their poor prognosis and because they often develop progressive neurologic
dysfunction that would confound the evaluation of neurologic and other adverse events

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to any of the agents used in the study

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements

- Pregnant women are excluded from this study because oxaliplatin is a platinating
agent with the potential for teratogenic or abortifacient effects; because there is
an unknown but potential risk for adverse events in nursing infants secondary to
treatment of the mother with oxaliplatin, breastfeeding should be discontinued if the
mother is treated with oxaliplatin; both men and women must agree to use birth
control pills or other active abortifacient; furthermore, at least 3 months must have
elapsed between the last pill of cetuximab and bevacizumab therapy; patients with
immune deficiency are at increased risk of lethal infections when treated with
marrow-suppressive therapy; therefore, HIV-positive patients receiving combination
anti-retroviral therapy are excluded from the study because of possible
pharmacokinetic interactions with oxaliplatin or other agents administered during the
study; appropriate studies will be undertaken in patients receiving combination
anti-retroviral therapy when indicated

- Serious or non-healing wound, ulcer or bone fracture

- Invasive procedures defined as follows:

- Major surgical procedure, open biopsy or significant traumatic injury within 28
days prior to Day 1 therapy

- Anticipation of need for major surgical procedures during the course of the

- Core biopsy within 7 days prior to D1 therapy

- If a patient is on full-dose anticoagulants, the following criteria should be met for

- The subject must have an in-range INR (usually between 2 and 3) on a stable dose
of warfarin or on stable dose of LMW heparin

- The subject must not have active bleeding or pathological conditions that carry
high risk of bleeding (e.g. tumor involving major vessels, known varices)

- Active infection requiring parental antibiotics on D1

- Proteinuria at baseline; subjects unexpectedly discovered to have >= 1+ proteinuria
will undergo a 24-hour urine collection, which will be < 1000 mg protein/ 24 hours to
be allowed participation in the study

- No currently active second malignancy other than non-melanoma skin cancer or
carcinoma in-situ of the cervix; patients are not considered to have a "currently
active" malignancy if they have completed therapy and have no evidence of recurrence
for at least 5 years

- Patients with clinically significant cardiovascular disease:

- Uncontrolled hypertension

- Myocardial infarction or unstable angina < 6 months prior to registration

- New York heart association grade II or greater congestive heart failure, serious
cardiac arrhythmia requiring medication, unstable angina pectoris

- Grade II or greater peripheral vascular disease

- CVA within 6 months of study entry

Type of Study:


Study Design:

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

Outcome Measure:

Severe adverse event (SAE) rate

Outcome Time Frame:

Up to 8 weeks

Safety Issue:


Principal Investigator

Allyson Ocean

Investigator Role:

Principal Investigator

Investigator Affiliation:

Montefiore Medical Center


United States: Food and Drug Administration

Study ID:




Start Date:

November 2004

Completion Date:

Related Keywords:

  • Adenocarcinoma of the Rectum
  • Mucinous Adenocarcinoma of the Colon
  • Recurrent Colon Cancer
  • Recurrent Rectal Cancer
  • Signet Ring Adenocarcinoma of the Colon
  • Stage IVA Colon Cancer
  • Stage IVA Rectal Cancer
  • Stage IVB Colon Cancer
  • Stage IVB Rectal Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Colonic Neoplasms
  • Rectal Neoplasms
  • Cystadenocarcinoma
  • Colorectal Neoplasms



Montefiore Medical Center Bronx, New York  10467-2490