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 December 2013 by Sanofi
Information provided by (Responsible Party):
First received: April 3, 2012
Last updated: December 10, 2013
Last verified: December 2013
To provide metastatic colorectal cancer patients with access to aflibercept and to document the overall safety in these patients
To document the Health-Related Quality of Life of aflibercept in this patient population
Colorectal Cancer Metastatic
Drug: AFLIBERCEPT AVE0005
||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||June 2015 (Final data collection date for primary outcome measure)
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
irinotecan, 5-FU and leucovorin
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01571284
||Clinical Sciences & Operations
No publications provided
History of Changes
|Other Study ID Numbers:
||AFLIBC06097, 2011-005724-17, U1111-1125-8949
|Study First Received:
||April 3, 2012
||December 10, 2013
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 11, 2013
Neoplasms, Second Primary
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases