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

This study is currently recruiting participants.
Verified April 2014 by Sanofi
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01571284
First received: April 3, 2012
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Colorectal Cancer Metastatic
Drug: AFLIBERCEPT AVE0005
Drug: FOLFIRI
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Number of participants reporting adverse events [ Time Frame: Up to 30 days after the end of treatment ] [ Designated as safety issue: Yes ]
  • Number of participants reporting laboratory abnormalities [ Time Frame: Up to 30 days after the end of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 900
Study Start Date: May 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aflibercept
One (1) hour intravenous infusion every two (2) weeks in combination with FOLFIRI (irinotecan, 5-Fluorouracil and leucovorin) regimen
Drug: AFLIBERCEPT AVE0005
Pharmaceutical form:Concentrate for solution for infusion Route of administration: intravenous
Drug: FOLFIRI
irinotecan, 5-FU and leucovorin

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01571284

Contacts
Contact: For site information, send an email with site number to Contact-Us@sanofi.com

  Show 160 Study Locations
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01571284     History of Changes
Other Study ID Numbers: AFLIBC06097, 2011-005724-17, U1111-1125-8949
Study First Received: April 3, 2012
Last Updated: April 16, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Oxaliplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014