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A Randomized Phase II Study of Irinotecan and Cetuximab With or Without the Anti-Angiogenic Antibody, Ramucirumab (IMC-1121B), in Advanced, K-ras Wild-Type Colorectal Cancer Following Progression on Bevacizumab-Containing Chemotherapy

Phase 2
18 Years
Not Enrolling
Colorectal Cancer

Thank you

Trial Information

A Randomized Phase II Study of Irinotecan and Cetuximab With or Without the Anti-Angiogenic Antibody, Ramucirumab (IMC-1121B), in Advanced, K-ras Wild-Type Colorectal Cancer Following Progression on Bevacizumab-Containing Chemotherapy


- To evaluate the progression-free survival of patients with advanced K-ras wild-type
colorectal cancer, following progression on bevacizumab-contained chemotherapy, treated
with irinotecan hydrochloride and cetuximab with versus without ramucirumab as
second-line therapy.

- To evaluate the response rate in patients treated with these regimens.

- To evaluate the grade 3-4 toxicity rates of these regimens in these patients.

- To evaluate the overall suvival of patients treated with these regimens.

OUTLINE: This is a multicenter, randomized study. Patients are stratified according to
performance status (0 vs 1), discontinuation of oxaliplatin before disease progression (yes
vs no), and time to disease progression since last treatment (≤ 6 months vs > 6 months).
Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive cetuximab IV over 60-120 minutes and irinotecan hydrochloride
over 60-90 minutes on day 1.

- Arm II: Patients receive ramucirumab IV over 60 minutes on day 1 and cetuximab and
irinotecan hydrochloride as in arm I.

In both arms, courses repeat every 14 days in the absence of disease progression or
unacceptable toxicity.

After completion of study therapy, patients are followed up periodically for 5 years.

Inclusion Criteria


- Histologically confirmed adenocarcinoma of the colon or rectum, including:

- Advanced disease

- Histologic variants of adenocarcinoma allowed

- K-ras wild type based on either primary or metastatic tumor

- No mutated type

- Measurable disease

- Must have received prior first-line therapy comprising oxaliplatin-based
fluoropyrimidine-containing chemotherapy and bevacizumab for metastatic colorectal

- No more than 42 days since confirmed disease progression

- No brain or CNS metastases


- Performance status 0-1

- ANC ≥ 1,500/μL

- Platelet count ≥ 75,000/μL

- Hemoglobin ≥ 9 g/dL

- Serum creatinine ≤ 1.5 times upper limit of normal (ULN) OR creatinine clearance ≥ 40

- Urine protein ≤ 1+ on dipstick or routine urinalysis (if ≥ 2+, a 24-hour urine
collection must demonstrate < 1,000 mg of protein)

- Total bilirubin ≤ 2.0 mg/dL

- AST and ALT ≤ 3.0 times ULN (5.0 times ULN for patients with liver metastases)

- INR ≤ 1.6 (≤ 3.0 for patients on warfarin and no active bleeding [i.e., no bleeding
within the past 14 days])

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 3 months after
completion of study therapy

- No clinically significant (equivalent to NCI CTCAE grade 3-4) bleeding episodes
within the past 3 months

- None of the following:

- Active infection

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Symptomatic or poorly controlled cardiac arrhythmia

- Uncontrolled thrombotic or hemorrhagic disorder

- No uncontrolled or poorly controlled hypertension despite standard medical management
(e.g., consistently systolic BP > 160 mm Hg and diastolic BP > 90 mm Hg)

- No acute arterial thrombotic events within the past 6 months, including
cerebrovascular accident, transient ischemic attack, myocardial infarction, or
unstable angina

- No other cancer requiring therapy within the past 3 years except in situ carcinoma or
nonmelanoma skin cancer

- No acute or subacute intestinal obstruction

- No history of inflammatory bowel disease requiring pharmacological and/or surgical
intervention within the past 12 months

- No known allergy to any of the treatment components


- See Disease Characteristics

- At least 28 days and no more than 90 days since prior bevacizumab

- No prior therapy with drugs other than oxaliplatin and a fluoropyrimidine plus
bevacizumab for colorectal cancer

- No major surgery within the past 28 days

- No subcutaneous venous access device placement within the past 7 days

- Concurrent stable dose of oral anticoagulant or low-molecular weight heparin allowed

Type of Study:


Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Safety Issue:


Principal Investigator

Howard S. Hochster, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

New York University School of Medicine


United States: Federal Government

Study ID:




Start Date:

November 2010

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • mucinous adenocarcinoma of the colon
  • recurrent colon cancer
  • signet ring adenocarcinoma of the colon
  • stage III colon cancer
  • stage IV colon cancer
  • mucinous adenocarcinoma of the rectum
  • recurrent rectal cancer
  • signet ring adenocarcinoma of the rectum
  • stage III rectal cancer
  • stage IV rectal cancer
  • Colorectal Neoplasms



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