Irinotecan Hydrochloride and Cetuximab With or Without Ramucirumab in Treating Patients With Advanced Colorectal Cancer With Progressive Disease After Treatment With Bevacizumab-Containing Chemotherapy



Status:Active, not recruiting
Conditions:Colorectal Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 120
Updated:12/16/2017
Start Date:October 8, 2010
End Date:July 1, 2023

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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

RATIONALE: Drugs used in chemotherapy, such as irinotecan hydrochloride, work in different
ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Monoclonal antibodies, such as cetuximab and ramucirumab, can block tumor growth in
different ways. Some block the ability of tumor cells to grow and spread. Others find tumor
cells and help kill them or carry tumor-killing substances to them. Cetuximab and ramucirumab
may also stop the growth of colorectal cancer by blocking blood flow to the tumor. It is not
yet know whether giving cetuximab and irinotecan hydrochloride together is more effective
with or without ramucirumab in treating colorectal cancer.

PURPOSE: This randomized phase II trial is studying the side effects and how well giving
cetuximab and irinotecan hydrochloride with or without ramucirumab work in treating patients
with advanced colorectal cancer with progressive disease after treatment with
bevacizumab-containing chemotherapy.

OBJECTIVES:

- 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.

DISEASE CHARACTERISTICS:

- 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
cancer

- No more than 42 days since confirmed disease progression

- No brain or CNS metastases

PATIENT CHARACTERISTICS:

- 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
mL/min

- 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

PRIOR CONCURRENT THERAPY:

- 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
We found this trial at
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
(505) 272-4946
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1802 6th Avenue South
Birmingham, Alabama 35294
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675 N Saint Clair St # 21-100
Chicago, Illinois 60611
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Robert H. Lurie Comprehensive Cancer Center at Northwestern University The cancer center was first established...
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2500 Metrohealth Dr # C2100
Cleveland, Ohio 44109
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MetroHealth Cancer Care Center at MetroHealth Medical Center At the MetroHealth Cancer Care Center, we...
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3535 Olentangy River Road
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Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas From its...
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100 North Academy Ave
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1719 East 19th Avenue
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1 Hurley Plaza
Flint, Michigan 48503
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Hurley Medical Center From its founding in 1908, Hurley Medical Center has devoted itself to...
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1920 Libal Street
Green Bay, Wisconsin 54307
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19229 Mack Ave
Grosse Pointe Woods, Michigan 48236
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200 North Park Street
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