Colorectal Cancer Metastatic (AFEQT)
To evaluate the safety of aflibercept in patients with metastatic Colorectal Cancer (mCRC) treated with irinotecan/5FU combination (FOLFIRI) after failure of an oxaliplatin-based regimen (patients similar to those evaluated in the VELOUR trial) according to side effects prevention and management guidelines.
To document the Health-Related Quality of Life (HRQL) of aflibercept in this patient population.
Colorectal Cancer Metastatic
Drug: AFLIBERCEPT AVE0005
|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 Evaluating Safety and Health Related Quality of Life of Aflibercept in Combination With Irinotecan/5FU Chemotherapy (FOLFIRI) in Patients With Metastatic Colorectal Cancer (mCRC) Previously Treated With an Oxaliplatin-Containing Regimen|
- Number of participants reporting Adverse Events [ Time Frame: up to a maximum of 6 months ] [ Designated as safety issue: Yes ]
- Health Related Quality of Life (HRQL) assessed by using changes from baseline in score derived from the 2 HRQL"questionnaires" [ Time Frame: Every 4 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
One (1) hour intravenous infusion on Day 1 followed by FOLFIRI (irinotecan, 5-Fluorouracil and leucovorin) administered as follows:
Treatment cycle to be administered every 2 weeks. Study treatment (aflibercept and FOLFIRI) has to be discontinued upon documentation of disease progression.
If FOLFIRI is permanently discontinued, then aflibercept should be continued until disease progression or unacceptable toxicity or patient's refusal of further treatment.
If aflibercept is permanently discontinued, then FOLFIRI can be continued until disease progression or unacceptable toxicity or patient's refusal of further treatment.
The end of treatment will be the date of the last treatment administration, either aflibercept or FOLFIRI whichever comes last
Drug: AFLIBERCEPT AVE0005
Pharmaceutical form:Concentrate for solution for infusion Route of administration: IntravenousDrug: irinotecan
Pharmaceutical form:Concentrate for solution for infusion Route of administration: IntravenousDrug: fluorouracil
Pharmaceutical form:Concentrate for solution for infusion Route of administration: IntravenousDrug: Leucovorin
Pharmaceutical form:Concentrate for solution for infusion Route of administration: Intravenous
Each patient will be treated until disease progression, unacceptable toxicity, death, Investigator's decision or patient's refusal for further treatment (whichever come first). Patients will be followed-up during treatment and for at least 30 days after its last study treatment (either aflibercept or FOLFIRI) administration, up to a maximum of 6 months.
|Contact: Trial Transparency Team||Contact-US@sanofi-aventis.com|
|Study Director:||Clinical Sciences & Operations||Sanofi|