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Safety and Quality of Life Study of Aflibercept in Patients With Metastatic Colorectal Cancer Previously Treated With an Oxaliplatin-Based Regimen

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ClinicalTrials.gov Identifier: NCT01571284
Recruitment Status : Completed
First Posted : April 5, 2012
Last Update Posted : March 1, 2017
Regeneron Pharmaceuticals
Information provided by (Responsible Party):

Brief Summary:

Primary Objective:

To provide metastatic colorectal cancer patients with access to aflibercept and to document the overall safety in these patients

Secondary Objective:

To document the Health-Related Quality of Life of aflibercept in this patient population

Condition or disease Intervention/treatment Phase
Colorectal Cancer Metastatic Drug: AFLIBERCEPT AVE0005 Drug: FOLFIRI Phase 3

Detailed Description:
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 administration.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 780 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2012
Primary Completion Date : January 2017
Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Aflibercept
One (1) hour intravenous infusion every two (2) weeks in combination with FOLFIRI (irinotecan, 5-Fluorouracil and leucovorin) regimen
Pharmaceutical form:Concentrate for solution for infusion Route of administration: intravenous
irinotecan, 5-FU and leucovorin

Primary Outcome Measures :
  1. Number of participants reporting adverse events [ Time Frame: Up to 30 days after the end of treatment ]
  2. Number of participants reporting laboratory abnormalities [ Time Frame: Up to 30 days after the end of treatment ]

Secondary Outcome Measures :
  1. Health-Related Quality of Life (HRQL) assessed by using changes from baseline in scores derived from the 3 HRQL questionnaires [ Time Frame: Every 4 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 uncontrolled.
  • 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 inclusion.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01571284

  Show 179 Study Locations
Sponsors and Collaborators
Regeneron Pharmaceuticals
Study Director: Clinical Sciences & Operations Sanofi

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01571284     History of Changes
Other Study ID Numbers: AFLIBC06097
U1111-1125-8949 ( Other Identifier: UTN )
First Posted: April 5, 2012    Key Record Dates
Last Update Posted: March 1, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antineoplastic Agents