A Study in Second Line Metastatic Colorectal Cancer



Status:Active, not recruiting
Conditions:Colorectal Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:December 2010
End Date:June 2016

Use our guide to learn which trials are right for you!

A Randomized, Double-blind, Multicenter Phase 3 Study of Irinotecan, Folinic Acid, and 5-Fluorouracil (FOLFIRI) Plus Ramucirumab or Placebo in Patients With Metastatic Colorectal Carcinoma Progressive During or Following First-Line Combination Therapy With Bevacizumab, Oxaliplatin, and a Fluoropyrimidine

The purpose of this study is to compare overall survival in participants with metastatic
colorectal cancer treated with either ramucirumab and FOLFIRI or placebo and FOLFIRI.


Inclusion Criteria:

- Histologically or cytologically confirmed colorectal cancer, excluding primary tumors
of appendiceal origin (participants are eligible to enroll irrespective of KRAS
mutation status)

- Confirmed metastatic colorectal cancer (Stage IV)

- The participant has received first-line combination therapy of bevacizumab,
oxaliplatin, and a fluoropyrimidine for metastatic disease and, a) Experienced
radiographic disease progression during first-line therapy, or b) Experienced
radiographic disease progression ≤6 months after the last dose of first-line therapy,
or c) Discontinued part or all of first-line therapy due to toxicity and experienced
radiographic disease progression ≤6 months after the last dose of first-line therapy.
Note that a participant must have received a minimum of 2 doses of bevacizumab as
part of a first-line regimen containing chemotherapy; in addition, a participant must
have received at least 1 cycle of first-line therapy that included bevacizumab,
oxaliplatin and a fluoropyrimidine in the same cycle. Note that a participant must
not have received more than 2 different fluoropyrimidines as part of a first-line
regimen; disease progression is not an acceptable reason for discontinuing 1
fluoropyrimidine and starting a second fluoropyrimidine

- Receipt of no more than 2 prior systemic chemotherapy regimens in any setting (only 1
prior regimen for metastatic disease is permitted). For participants with rectal
cancer, sequential neoadjuvant and adjuvant therapy will count as a single systemic
regimen. Note that rechallenge with oxaliplatin is permitted and will be considered
part of the first-line regimen for metastatic disease, both initial oxaliplatin
treatment and subsequent rechallenge are considered as 1 regimen

- Measurable or nonmeasurable disease based on the Response Evaluation Criteria in
Solid Tumors, Version 1.1 (RECIST v1.1)

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1

- Adequate hematologic, renal and hepatic function

- Adequate coagulation function [International Normalized Ratio (INR) ≤1.5 and Partial
Thromboplastin Time (PTT) or activated PTT (aPTT) ≤1.5 x upper limit of normal
(ULN)). Participants on full-dose anticoagulation must be on a stable dose of
anticoagulant therapy and if on oral anticoagulation, must have an INR ≤3 and have no
clinically significant active bleeding or pathological condition that carries a high
risk of bleeding

- Consent to provide a historical colorectal cancer tissue sample for assessment of
biomarkers and the tumor tissue sample is available

- Ability to provide signed informed consent

Exclusion Criteria:

- Receipt of bevacizumab ≤28 days prior to randomization

- Receipt of any investigational therapy for non-oncology clinical indication ≤28 days
prior to randomization

- Receipt of any previous systemic therapy, other than a combination of bevacizumab,
oxaliplatin, and a fluoropyrimidine, for first-line treatment of metastatic
colorectal cancer

- Known leptomeningeal disease or brain metastases or uncontrolled spinal cord
compression (currently or in the past)

- Experience of any arterial thrombotic or arterial thromboembolic events, including,
but not limited to, myocardial infarction, transient ischemic attack, or
cerebrovascular accident, ≤12 months prior to randomization

- Pregnant (confirmed by serum beta human chorionic gonadotropin (ß HCG) test ≤7 days
prior to randomization) or lactating

- History of inflammatory bowel disease or Crohn's disease requiring medical
intervention (immunomodulatory or immunosuppressive medications or surgery) ≤12
months prior to randomization

- Acute or subacute bowel obstruction or history of chronic diarrhea which is
considered clinically significant in the opinion of the investigator

- Grade 3 or higher bleeding event ≤3 months prior to randomization

- Experience of any of the following during first-line therapy with a
bevacizumab-containing regimen: an arterial thrombotic/thromboembolic event, Grade 4
hypertension, Grade 3 proteinuria, a Grade 3-4 bleeding event, or bowel perforation

- Known history or clinical evidence of Gilbert's Syndrome, or is known to have any of
the following genotypes: UGT1A1*6/*6, UGT1A1*28/*28, or UGT1A1*6/*28

- Known allergy to any of the study treatment components, including any components used
in the preparation of ramucirumab, or other contraindication to receive the study
treatments

- Cirrhosis at a level of Child-Pugh B (or worse) or cirrhosis (any degree) and a
history of hepatic encephalopathy or clinical meaningful ascites resulting from
cirrhosis; Clinically meaningful ascites is defined as ascites resulting from
cirrhosis and requiring ongoing treatment with diuretics and/or paracentesis
We found this trial at
94
sites
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
?
mi
from
Abilene, TX
Click here to add this to my saved trials
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
?
mi
from
Arlington, TX
Click here to add this to my saved trials
?
mi
from
Athens, GA
Click here to add this to my saved trials
?
mi
from
Augusta, GA
Click here to add this to my saved trials
?
mi
from
Beaumont, TX
Click here to add this to my saved trials
?
mi
from
Bedford, TX
Click here to add this to my saved trials
?
mi
from
Bend, OR
Click here to add this to my saved trials
?
mi
from
Bethesda, MD
Click here to add this to my saved trials
?
mi
from
Billings, MT
Click here to add this to my saved trials
?
mi
from
Boynton Beach, FL
Click here to add this to my saved trials
?
mi
from
Bronx, NY
Click here to add this to my saved trials
?
mi
from
Buenos Aires,
Click here to add this to my saved trials
?
mi
from
Cherry Hill, NJ
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
?
mi
from
Columbia, MO
Click here to add this to my saved trials
?
mi
from
Columbia, SC
Click here to add this to my saved trials
?
mi
from
Columbus, OH
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Denton, TX
Click here to add this to my saved trials
?
mi
from
Denver, CO
Click here to add this to my saved trials
?
mi
from
Duarte, CA
Click here to add this to my saved trials
?
mi
from
Escondido, CA
Click here to add this to my saved trials
?
mi
from
Fairfax, VA
Click here to add this to my saved trials
?
mi
from
Fayetteville, AR
Click here to add this to my saved trials
?
mi
from
Flower Mound, TX
Click here to add this to my saved trials
?
mi
from
Fort Lauderdale, FL
Click here to add this to my saved trials
?
mi
from
Fort Myers, FL
Click here to add this to my saved trials
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
?
mi
from
Fresno, CA
Click here to add this to my saved trials
?
mi
from
Ft. Worth, TX
Click here to add this to my saved trials
?
mi
from
Garland, TX
Click here to add this to my saved trials
?
mi
from
Goshen, IN
Click here to add this to my saved trials
?
mi
from
Greenbrae, CA
Click here to add this to my saved trials
?
mi
from
Hackensack, NJ
Click here to add this to my saved trials
?
mi
from
Harvey, IL
Click here to add this to my saved trials
?
mi
from
Honolulu, HI
Click here to add this to my saved trials
?
mi
from
Hudson, NY
Click here to add this to my saved trials
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
?
mi
from
Jamaica, NY
Click here to add this to my saved trials
?
mi
from
Kennewick, WA
Click here to add this to my saved trials
?
mi
from
Kingston, PA
Click here to add this to my saved trials
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
?
mi
from
Macon, GA
Click here to add this to my saved trials
?
mi
from
Marietta, GA
Click here to add this to my saved trials
?
mi
from
McAllen, TX
Click here to add this to my saved trials
?
mi
from
Memphis, TN
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
?
mi
from
Morristown, NJ
Click here to add this to my saved trials
?
mi
from
Muncie, IN
Click here to add this to my saved trials
?
mi
from
Nashville, TN
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
?
mi
from
Newport News, VA
Click here to add this to my saved trials
?
mi
from
Ocala, FL
Click here to add this to my saved trials
?
mi
from
Odessa, TX
Click here to add this to my saved trials
?
mi
from
Ogden, UT
Click here to add this to my saved trials
?
mi
from
Paris, TX
Click here to add this to my saved trials
?
mi
from
Peoria, IL
Click here to add this to my saved trials
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
?
mi
from
Port St Lucie, FL
Click here to add this to my saved trials
?
mi
from
Portland, OR
Click here to add this to my saved trials
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
Rancho Cucamonga, California 91730
?
mi
from
Rancho Cucamonga, CA
Click here to add this to my saved trials
?
mi
from
Richmond, VA
Click here to add this to my saved trials
?
mi
from
Rome, GA
Click here to add this to my saved trials
?
mi
from
Round Rock, TX
Click here to add this to my saved trials
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
?
mi
from
San Diego, CA
Click here to add this to my saved trials
?
mi
from
Seattle, WA
Click here to add this to my saved trials
?
mi
from
Sedona, AZ
Click here to add this to my saved trials
?
mi
from
Sherman, TX
Click here to add this to my saved trials
Spokane Valley, Washington 99216
?
mi
from
Spokane Valley, WA
Click here to add this to my saved trials
?
mi
from
St Louis, MO
Click here to add this to my saved trials
?
mi
from
St. Petersburg, FL
Click here to add this to my saved trials
?
mi
from
Sugar Land, TX
Click here to add this to my saved trials
?
mi
from
Temple, TX
Click here to add this to my saved trials
?
mi
from
The Woodlands, TX
Click here to add this to my saved trials
?
mi
from
Thomasville, GA
Click here to add this to my saved trials
?
mi
from
Titusville, FL
Click here to add this to my saved trials
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
?
mi
from
Tulsa, OK
Click here to add this to my saved trials
?
mi
from
Tyler, TX
Click here to add this to my saved trials
?
mi
from
Waco, TX
Click here to add this to my saved trials
?
mi
from
Warrenville, IL
Click here to add this to my saved trials
?
mi
from
Waterbury, CT
Click here to add this to my saved trials
?
mi
from
Webster, TX
Click here to add this to my saved trials
?
mi
from
Wichita Falls, TX
Click here to add this to my saved trials
Willow Grove, Pennsylvania 19090
?
mi
from
Willow Grove, PA
Click here to add this to my saved trials
?
mi
from
Winchester, VA
Click here to add this to my saved trials