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A Multinational, Randomized, Double-Blind Study Comparing Aflibercept Versus Placebo Every 2 Weeks in Asian Patients With Metastatic Colorectal Cancer (MCRC) Treated With Irinotecan/5-FU Combination (FOLFIRI) After Failure of an Oxaliplatin Based Regimen

Phase 3
18 Years
Open (Enrolling)
Colorectal Cancer Metastatic

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Trial Information

A Multinational, Randomized, Double-Blind Study Comparing Aflibercept Versus Placebo Every 2 Weeks in Asian Patients With Metastatic Colorectal Cancer (MCRC) Treated With Irinotecan/5-FU Combination (FOLFIRI) After Failure of an Oxaliplatin Based Regimen

Screening occurs from signed informed consent to randomization (up to 21 days). A treatment
cycle is defined as a 2 week-period. All patients will be followed during the study
treatment and follow-up period until death or study cut off date, which ever comes first.

Inclusion Criteria

Inclusion criteria:

- Histological or cytological proven adenocarcinoma of the colon or rectum.

- Metastatic disease that is not amenable to potentially curative treatment.

- One and only one prior chemotherapeutic regimen for metastatic disease. This prior
chemotherapy must be an oxaliplatin containing regimen. Patients who relapse within 6
months of completion of oxaliplatin based adjuvant chemotherapy are eligible.

Exclusion criteria:

- Prior therapy with irinotecan.

- Eastern Cooperative Oncology Group (ECOG) performance status >1.

- Less than 28 days elapsed from prior radiotherapy, from prior surgery and prior
chemotherapy to the time of randomization. Less than 42 days elapsed from prior major
surgery to the time to randomization.

- Adverse events (with exception of alopecia, peripheral sensory neuropathy grade ≤ 2
and those listed in specific exclusion criteria) from any prior anticancer therapy of
grade >1 (National Cancer Institute Common terminology Criteria [NCI CTCAE] v.3.0) at
the time of randomization.

- Age <18 years.

- History of brain metastases, uncontrolled spinal cord compression, or carcinomatous
meningitis or new evidence of brain or leptomeningeal disease

- Other prior malignancy. Adequately treated basal cell or squamous cell skin cancer,
carcinoma in situ of the cervix or any other cancer from which the patient has been
disease free for > 5 years are allowed.

- Participation in another clinical trial with an investigational drug and any
concurrent treatment with any investigational drug within 30 days prior to

- Any of the following within 6 months prior to randomization: myocardial infarction,
severe/unstable angina pectoris, coronary/peripheral artery bypass graft, NYHA class
III or IV congestive heart failure, stroke or transient ischemic attack.

- Any of the following within 3 months prior to randomization: treatment resistant
peptic or duodenal ulcer disease, erosive oesophagitis or gastritis, grade 3 or 4
gastrointestinal bleeding/hemorrhage, gastrointestinal perforation/fistula, abdominal
abscess, infectious or inflammatory bowel disease, diverticulitis, pulmonary
embolism, or other uncontrolled thromboembolic event.

- Patients who had or are having high dose aspirin or NSAIDS (non steroidal
anti-inflammatory agents) or high steroids within 4 weeks prior to randomization. The
definition of "high dose" will be based on the investigator's judgment.

- Occurrence of deep vein thrombosis within 4 weeks, prior to randomization.

- Inadequate organ or bone marrow function.

- Pregnant or breast-feeding woman. Positive serum or urine pregnancy test prior to
randomization. Patients with reproductive (M/F) who do not agree to use accepted and
effective method of contraception during the study treatment period and for at least
6 months following completion of study treatment.

- Uncontrolled hypertension.

- Urine Protein:creatine ratio(UPCR)>1 on morning spot urinalysis or proteinuria>

- Patients on anticoagulant therapy with unstable dose of warfarin and/or having an
out-of-therapeutic range INR (>3) within 4 weeks prior to randomization.

- Evidence of clinically significant bleeding diathesis or underlying coagulopathy.

- Known dihydropyrimidine dehydrogenase deficiency.

- Predisposing colonic or small bowel disorder in which the symptoms were uncontrolled
as indicated by baseline of > 3 loose stools daily.

- Prior history of chronic enteropathy, inflammatory enteropathy, chronic diarrhea,
unresolved bowel obstruction/sub-obstruction, more than hemicolectomy, extensive
small intestine resection with chronic diarrhea.

- History of anaphylaxis or known intolerance to atropine sulphate or loperamide or
appropriate antiemetics to be administered in conjunction with FOLFIRI.

- Treatment with concomitant anticonvulsant agents that are CYP3A4 inducers (phenytoin,
phenobarbital, carbamazepine), unless discontinued >7 days.

- Patients with known Gilbert's syndrome.

The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival

Outcome Time Frame:

7 months (the average)

Safety Issue:


Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:



China: Ethics Committee

Study ID:




Start Date:

July 2012

Completion Date:

January 2016

Related Keywords:

  • Colorectal Cancer Metastatic
  • Colorectal Neoplasms
  • Neoplasms
  • Neoplasms, Second Primary