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
255
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1580 Beam Ave
Maplewood, Minnesota 55109
(651) 779-7978
Minnesota Oncology - Maplewood At Minnesota Oncology, we join together with you in a firm...
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
(505) 272-4946
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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1802 6th Avenue South
Birmingham, Alabama 35294
(205) 934-4011
UAB Comprehensive Cancer Center One of the nation’s leading cancer research and treatment centers, the...
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675 N Saint Clair St # 21-100
Chicago, Illinois 60611
(312) 695-1156
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
(216) 778-5802
MetroHealth Cancer Care Center at MetroHealth Medical Center At the MetroHealth Cancer Care Center, we...
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3535 Olentangy River Road
Columbus, Ohio 43214
(614) 566-5000
Riverside Methodist Hospital Cancer Care Serving central Ohio since 1892, Riverside Methodist is consistently ranked...
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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
Danville, Pennsylvania 17822
570-271-6211
Geisinger Cancer Institute at Geisinger Health Since 1915, Geisinger Medical Center has been known as...
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1719 East 19th Avenue
Denver, Colorado 80218
(303) 839-6000
Presbyterian - St. Luke's Medical Center Presbyterian/St. Luke's Medical Center and the Rocky Mountain Hospital...
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1 Hurley Plaza
Flint, Michigan 48503
(810) 262-9000
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
(920) 433-8889
St. Vincent Hospital Regional Cancer Center Our group of 19 oncologists, including the region's only...
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19229 Mack Ave
Grosse Pointe Woods, Michigan 48236
(866) 246-4673
Van Elslander Cancer Center at St. John Hospital and Medical Center We built the Van...
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200 North Park Street
Kalamazoo, Michigan 49007
(269) 382-2500
West Michigan Cancer Center In 1994, Borgess Health Alliance and Bronson Healthcare Group opened the...
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524 South Park Street
Kalamazoo, Michigan 49007
(269) 341-7654
Bronson Methodist Hospital Our healthcare system serves patients and families throughout southwest Michigan and northern...
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825 N Emporia Ave
Wichita, Kansas 67214
(316) 261-3200
Via Christi Cancer Center at Via Christi Regional Medical Center Via Christi Health's rich history...
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777 Kimole Ln
Adrian, Michigan 49221
517-265-0900
Hickman Cancer Center at Bixby Medical Center At ProMedica Bixby Hospital, we
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161 North Forge Street
Akron, Ohio 44304
(330) 375-7280
Summa Center for Cancer Care at Akron City Hospital Summa Health System is a leader...
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Albuquerque, New Mexico 87106
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Ames, Iowa 50010
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5301 McAuley Drive
Ann Arbor, Michigan 48197
734-712-4673
Saint Joseph Mercy Cancer Center Saint Joseph Mercy Health System is one of Michigan's most...
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5301 East Huron River Drive
Ann Arbor, Michigan 48106
1.877.590.5995
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Antigo, Wisconsin 54409
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700 Potomac St
Aurora, Colorado 80012
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6701 North Charles Street
Baltimore, Maryland 21204
443-849-3051
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4950 Essen Ln
Baton Rouge, Louisiana 70809
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1233 34th St NW
Bemidji, Minnesota 56601
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2200 E Washington St,
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1100 Balsam Ave
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960 W. Wooster
Bowling Green, Ohio 43402
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Wood County Oncology Center The Cancer Care Center at Wood County Hospital opened March 2014,...
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130 S Bryn Mawr Ave
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201 E Nicollet Blvd
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210 W Walnut St
Canton, Illinois 61520
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1454 North County Road 2050
Carthage, Illinois 62321
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Memorial Hospital Memorial Hospital is a vital force in establishing and maintaining the well-being of...
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701 10th St SE
Cedar Rapids, Iowa 52403
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525 10th St SE
Cedar Rapids, Iowa 52403
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505 S Plummer Ave
Chanute, Kansas 66720
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3110 MacCorkle Ave. S.E.
Charleston, West Virginia 25304
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1969 W Ogden Ave
Chicago, Illinois 60612
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676 N St Clair St #2140
Chicago, Illinois 60611
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Hematology and Oncology Associates Northwestern Medical Faculty Foundation (the Foundation) is a premier, multi-specialty physician...
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272 Hospital Rd
Chillicothe, Ohio 45601
740-779-7500
Adena Regional Medical Center Since 1895, Adena Health System has remained focused on its commitment...
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11100 Euclid Avenue
Cleveland, Ohio 44106
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2222 N. Nevada Avenue
Colorado Springs, Colorado 80907
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111 S Grant Avenue
Columbus, Ohio 43215
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Columbus, Ohio 43228
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1335 Dublin Road, Suite 124A
Columbus, Ohio 43215
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793 West State Street
Columbus, Ohio 43222
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11850 Blackfoot St. NW Suite 130
Coon Rapids, Minnesota 55433
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Covington, Louisiana 70433
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5201 Harry Hines Blvd
Dallas, Texas 75235
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18101 Oakwood Blvd
Dearborn, Michigan 48124
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2300 N. Edward Street
Decatur, Illinois 62526
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561 W. Central Avenue
Delaware, Ohio 43015
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11600 W 2nd Pl
Denver, Colorado 80204
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2525 S Downing St
Denver, Colorado 80210
(303) 778-1955
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Denver, Colorado 80218
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4567 E 9th Ave
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300 East Locust St., Ste 350
Des Moines, Iowa 50309
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1221 Pleasant St
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1221 Pleasant St Suite 100
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2020 Central Ave
Dodge City, Kansas 67801
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400 E Third Street
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6401 France Ave S
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700 West Central
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41201 Schadden Rd
Elyria, Ohio 44035
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6282 Linton Blvd
Elyria, Ohio 44035
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Englewood, Colorado 80113
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101 S Major St
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820 4th Street North
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1024 S Lemay Ave
Fort Collins, Colorado 80524
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550 Osborne Road
Fridley, Minnesota 55432
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3315 N. Seminary Street
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114 Woodland St, Hartford
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615 N. Promenade Street
Havana, Illinois 62644
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