- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02181556
Efficacy and Safety of Aflibercept in Combination With FOLFIRI Chemotherapy as 1st Line Treatment for Patients With Metastatic Colorectal Cancer
One of the treatments generally used to treat this disease is a chemotherapy called FOLFIRI. The purpose of this study is to improve the efficacy of the chemotherapy by adding a protein, similar to immunoglobulins, aflibercept, and to assess their tolerance.
Aflibercept is a protein that has already been studied in the treatment of metastatic colorectal cancers, in combination with a chemotherapy involving irinotecan in addition to 5FU (fluoropyrimidine) ( (FOLFIRI) as 2nd line treatment. It is marketed in Europe and it is authorized in the United States. Its addition to this chemotherapy combination has in fact brought about a benefit in terms of progression-free survival and overall survival.
The purpose of the study is to evaluate the efficacy and tolerance of this combination rather in the initial approach to the treatment of metastatic colorectal cancers and hence to evaluate it as 1st line treatment
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Angers, France
- CHU - Hôtel Dieu
-
Bobigny, France, 93000
- Hopital Avicenne
-
Dijon, France, 21079
- CHU - Hôpital François Mitterand
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Lyon, France
- Clinique Jean Mermoz
-
Marseille, France, 13000
- La Timone
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Paris, France
- Hôpital La Pitié Salpetière
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Paris, France, 75020
- Hôpital Européen Geaorge Pompidou (HEGP)
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Tours, France, 37044
- Hôpital Trousseau
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: FOLFIRI + Aflibercept
FOLFIRI and aflibercept (4 mg/m²) each 14 days until progression of disease
|
injection of FOLFIRI and Aflibercept every 14 days until progression of disease
injection of FOLFIRI and Aflibercept every 14 days until progression of disease
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of Patients Alive and Progression-free 6 Months After Inclusion.
Time Frame: 6 months
|
Progression was evaluated by CT scan, according to RECIST criteria (version 1.1) definition by the investigator. Death was also considered as an event (all causes). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions compared the little sum of diameters observed during the study (NADIR), or a measurable increase in a non-target lesion, or the appearance of new lesions |
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival
Time Frame: Up to 2 years after the end of the treatment
|
Overall survival is defined as the time from the date of the patient's inclusion to the patient's death (all causes).
For alive patients the date of the latest news is taken into account
|
Up to 2 years after the end of the treatment
|
Progression-free Survival
Time Frame: up to 12 months
|
The progression-free survival is the time from inclusion to the first radiological progression or death (all causes). For patients alive without progression date of last news will be considered. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions compared the little sum of diameters observed durin the study (NADIR), or a measurable increase in a non-target lesion, or the appearance of new lesions |
up to 12 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Julien TAIEB, PhD, Federation Francophone de Cancerologie Digestive
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Physiological Effects of Drugs
- Antineoplastic Agents
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Aflibercept
Other Study ID Numbers
- FFCD 1302
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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