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A Multicenter, Single Arm, Open Label Clinical Trial to Evaluate the Safety and Health-Related Quality of Life of Aflibercept in Patients With Metastatic Colorectal Cancer (mCRC) Previously Treated With an Oxaliplatin-Containing Regimen

Phase 3
18 Years
Open (Enrolling)
Colorectal Cancer Metastatic

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Trial Information

A Multicenter, Single Arm, Open Label Clinical Trial to Evaluate the Safety and Health-Related Quality of Life of Aflibercept in Patients With Metastatic Colorectal Cancer (mCRC) Previously Treated With an Oxaliplatin-Containing Regimen

Each patient will be treated until disease progression, unacceptable toxicity, death,
Investigator's decision or patient's refusal for further treatment (whichever comes first).
Patients will be followed-up during study treatment and for at least 30 days after last

Inclusion Criteria

Inclusion criteria :

- Histologically or cytologically proven adenocarcinoma of the colon or rectum

- Metastatic disease

- Eastern Cooperative Oncology Group performance status 0-1

- One and only one prior chemotherapeutic regimen for metastatic disease. This prior
chemotherapy must be an oxaliplatin containing regimen. Patients must have progressed
during or after the oxaliplatin based chemotherapy. Patients relapsed within 6 months
of completion of oxaliplatin adjuvant chemotherapy are eligible.

Exclusion criteria:

- Prior therapy with irinotecan

- Inadequate bone marrow, liver and renal function: neutrophils < 1.5x109/L, platelets
< 100x109/L, hemoglobin < 9.0 g/dL, total bilirubin >1.5 x upper normal limit (ULN),
transaminases >3 x ULN (unless liver metastasis are present), alkaline phosphatase >3
x ULN (unless liver metastasis are present), serum creatinine > 1.5 x ULN.

- Less than 4 weeks from prior radiotherapy, prior chemotherapy, prior major surgery
(or until the surgical wound is fully healed).

- Treatment with any investigational drug within the prior 30 days.

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

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

- Prior malignancy (other than colorectal) including prior malignancy from which the
patient has been disease free for < 5 years (except adequately treated basal or
squamous cell skin cancer or carcinoma in situ of the cervix).

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

- Any of the following within 3 months prior study inclusion: severe gastrointestinal
bleeding/hemorrhage, treatment resistant peptic ulcer disease, erosive oesophagitis
or gastritis, infectious or inflammatory bowel disease, diverticulitis, pulmonary
embolism or other uncontrolled thromboembolic event.

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

- Known dihydropyrimidine dehydrogenase deficiency.

- Predisposing colonic or small bowel disorders in which the symptoms were

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

- Known Gilbert's syndrome.

- Unresolved or unstable toxicity from any prior anti cancer therapy at the time of

- History of anaphylaxis or known intolerance to atropine sulphate or loperamide or
appropriate antiemetics to be administered in conjunction with FOLFIRI (irinotecan,
5-Fluorouracil, leucovorin).

- Severe acute or chronic medical condition, which could impair the ability of the
patient to participate to the study.

- Urine protein-creatinine ratio (UPCR) >1 on morning spot urinalysis or proteinuria >
500 mg/24-h.

- Uncontrolled hypertension within 3 months prior to study inclusion.

- Patients on anticoagulant therapy with unstable dose of warfarin and/or having an
out-of-therapeutic range INR within the 4 weeks prior to study inclusion.

- Evidence of clinically significant bleeding predisposition or underlying
coagulopathy, non-healing wound.

- Pregnant or breast-feeding women.

- Patients with reproductive potential who do not agree to use an accepted effective
method of contraception.

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:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of participants reporting adverse events

Outcome Time Frame:

Up to 30 days after the end of treatment

Safety Issue:


Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

May 2012

Completion Date:

June 2015

Related Keywords:

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



Investigational Site Number 840-002 Muscle Shoals, Alabama  35661
Investigational Site Number 840-008 Corona, California  92879
Investigational Site Number 840-007 Fountain Valley, California  92708
Investigational Site Number 840-004 Riverside, California  92501
Investigational Site Number 840-006 Indianapolis, Indiana  46254
Investigational Site Number 840-011 Metairie, Louisiana  70006
Investigational Site Number 840-001 Rockville, Maryland  20850
Investigational Site Number 840-010 Howell, New Jersey  07731
Investigational Site Number 840-012 Albuquerque, New Mexico  87106
Investigational Site Number 840-009 Farmington, New Mexico  87401
Investigational Site Number 840-003 Lake Success, New York  11042
Investigational Site Number 840-005 Middletown, Ohio  45042