A Study of IMC-1121B or IMC-18F1 in Colorectal Cancer

The purpose of this study is to evaluate the progression-free survival (PFS) in patients
with metastatic colorectal cancer when treated with 1 of 3 modified FOLFOX-6 (folinic acid
[FA] + fluorouracil [5-FU] + oxaliplatin [mFOLFOX-6])-based regimens, as second-line
therapy.

During 2010, there has been an identified shortage of injectable folinic acid (FA) in the
United States. Levo-folinic acid (LFA) will be allowed as a substitute for FA in the
mFOLFOX-6 chemotherapy regimen in circumstances in which FA is not available, to facilitate
continuity of patient care.

Inclusion Criteria:

- Disease progression on an irinotecan-based first-line chemotherapy regimen (ie
FOLFIRI or CAPIRI [capecitabine + irinotecan], with or without bevacizumab)

- Age ≥ 18 years

- Life expectancy of ≥ 6 months

- ECOG PS (Eastern Cooperative Oncology Group Performance Status) 0-1 at study entry

- Agrees to adequate contraception during the study period and for 12 weeks after the
last dose of study medication

- Provided signed informed consent

Exclusion Criteria:

- Has received prior oxaliplatin-based chemotherapy for locally advanced unresectable
or metastatic CRC (Prior oxaliplatin-based adjuvant chemotherapy is allowed if the
last dose of oxaliplatin was administered > 12 months prior to randomization)

- Has documented and/or symptomatic brain or leptomeningeal metastases

- Has an ongoing or active infection, symptomatic or poorly controlled cardiac
arrhythmia, psychiatric illness/social situations, or any other serious uncontrolled
medical disorders

- On chronic non-topical corticosteroid treatment. A patient discontinuing such
treatment > 3 months prior to randomization is eligible

- Has uncontrolled or poorly controlled hypertension on a standard regimen of
antihypertensive therapy

- Has a concurrent active malignancy. A patient with previous history of malignancy is
eligible, provided that he/she has been disease free for > 3 years

- If female, is pregnant (confirmed by serum beta human chorionic gonadotropin [βHCG]
test) or lactating

- Has received a prior autologous or allogeneic organ or tissue transplantation

- Has undergone major surgery within 28 days prior to randomization

- Has had a serious nonhealing wound, ulcer, or bone fracture within 28 days prior to
randomization

- Has an elective or planned major surgery to be performed during the course of the
trial

- Has a history of inflammatory bowel disease requiring pharmacological and/or surgical
intervention in the 12 months prior to randomization