Efficacy and Safety of Aflibercept in Combination With FOLFIRI Chemotherapy as 1st Line Treatment for Patients With Metastatic Colorectal Cancer
Launched by FEDERATION FRANCOPHONE DE CANCEROLOGIE DIGESTIVE · Jul 2, 2014
Trial Information
Current as of July 22, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Age ≥ 18 years
- • Overall state as per WHO (World Health Organization) ≤ 2
- • Life expectancy \> 3 months
- • Metastatic adenocarcinoma of the rectum or of the colon histologically proven on the primary tumor or a metastasis
- • Unresectable metastasis (metastases) and/or inoperable patient
- • Patient eligible for a 1st line treatment associating 5 FU-Irinotecan (FOLFIRI) and aflibercept
- • At least one measurable target lesion according to RECIST criteria v1.1 not previously irradiated
- • Absence of prior treatment of the metastatic disease. Prior adjuvant chemotherapy completed at least 12 months before the metastatic cancer diagnosis is authorized
- • Satisfactory laboratory panel: Hb\> 9 g/dl, polynuclear neutrophils \> 1500 /mm3, platelets \> 100,000/mm3, total bilirubin \< 1.5 x UNL(upper normal limit), creatinine clearance \> 50 mL/min (cockcroft-Gault formula - appendix 4), PAL (alkaline phosphatase) \< 5 x UNL, AST (aspartate aminotransferase) and ALT (alanine aminotransferases) \< 5 x UNL, GGT (gamma-glutamyltransferase) \< 5 x UNL,
- • Proteinuria on urine dipstick \< 2+. If \> 2+ test 24-hour proteinuria, which should be \< 1 g
- Exclusion Criteria:
- • Patients whose primary tumor is in place and presenting clinical symptoms (occlusion; hemorrhage)
- • Brain metastases
- • Gilbert's syndrome
- • Uncontrolled hypercalcemia
- • Hypertension not kept under control (SBP (Systolic Blood Pressure) \>150 mmHg and DBP (Diastolic Blood Pressure) \>100 mmHg) or history of hypertensive crisis or hypertensive encephalopathy
- • Any unbalanced active disease over the last 6 months: liver failure, kidney failure, respiratory failure, congestive heart failure, unstable angina, myocardial infarction, significant arrhythmia (Patients treated by anticoagulants (coumadin, warfarin) are eligible if strict monitoring of the INR( international normalized ratio) is possible)
- • Significant surgical intervention within the 28 days before the start of treatment
- • Presence of active gastroduodenal ulcer, non-healed wound or bone fracture
- • Antitumor treatments other than those included in the study (chemotherapy, targeted therapy, immunotherapy)
- • History of malignant hemopathy or cancer except for those treated more than 5 years ago and considered healed, in situ carcinomas of the uterine cervix and treated skin cancers (except for melanoma)
- • Pregnant or breast-feeding women, women of childbearing age not having taken a pregnancy test, absence of effective contraception in patients (men and/or women) of childbearing age
- • Any contraindication of the drugs used in the study
- • Impossible to meet the medical follow-up requirements of the study for geographic, social or psychological reasons
About Federation Francophone De Cancerologie Digestive
The Federation Francophone de Cancérologie Digestive (FFCD) is a prominent clinical trial sponsor dedicated to advancing research in digestive cancers. Comprising a collaborative network of healthcare professionals, researchers, and institutions across the French-speaking world, the FFCD focuses on enhancing patient outcomes through innovative clinical trials and the dissemination of knowledge. By fostering multidisciplinary collaboration and promoting high-quality research, the FFCD aims to improve treatment strategies and ultimately contribute to the global understanding of digestive oncology. Their commitment to excellence in clinical research underscores their role as a key player in the fight against digestive cancers.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Tours, , France
Bobigny, , France
Angers, , France
Dijon, , France
Lyon, , France
Marseille, , France
Paris, , France
Paris, , France
Patients applied
Trial Officials
Julien TAIEB, PhD
Principal Investigator
Fédération Francophone de Cancérologie Digestive
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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