Efficacy and Safety of Aflibercept in Combination With FOLFIRI Chemotherapy as 1st Line Treatment for Patients With Metastatic Colorectal Cancer

NCT02181556 | Completed Phase 2 Results DMC

• 1 other identifier: FFCD 1302
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 8

Brief Summary

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

Conditions

Metastatic Colorectal Cancer

Keywords

colorectal cancer; Metastatic

Outcome Measures

Primary Outcomes (1)

• Rate of Patients Alive and Progression-free 6 Months After Inclusion.

  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 Outcomes (2)

• Overall Survival

  Up to 2 years after the end of the treatment

• Progression-free Survival

  up to 12 months

Study Arms (1)

FOLFIRI + Aflibercept

EXPERIMENTAL

FOLFIRI and aflibercept (4 mg/m²) each 14 days until progression of disease

Drug: FOLFIRI Protocol; Drug: Aflibercept Injection

Interventions

FOLFIRI Protocol DRUG

injection of FOLFIRI and Aflibercept every 14 days until progression of disease

FOLFIRI + Aflibercept

Aflibercept Injection DRUG

injection of FOLFIRI and Aflibercept every 14 days until progression of disease

FOLFIRI + Aflibercept

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federation Francophone de Cancerologie Digestive: lead

Study Sites (8)

CHU - Hôtel Dieu

Angers, France

Location

Hôpital Avicenne

Bobigny, 93000, France

Location

CHU - Hôpital François Mitterand

Dijon, 21079, France

Location

Clinique Jean Mermoz

Lyon, France

Location

La Timone

Marseille, 13000, France

Location

Hôpital Européen Geaorge Pompidou (HEGP)

Paris, 75020, France

Location

Hôpital La Pitié Salpetière

Paris, France

Location

Hôpital Trousseau

Tours, 37044, France

Location

Related Publications (1)

• Lapeyre-Prost A, Pernot S, Sigrand J, Le Malicot K, Mary F, Aparicio T, Dahan L, Caroli-Bosc FX, Lecomte T, Doat S, Marthey L, Desrame J, Lepage C, Taieb J. Aflibercept in Combination With FOLFIRI as First-line Chemotherapy in Patients With Metastatic Colorectal Cancer (mCRC): A Phase II Study (FFCD 1302). Clin Colorectal Cancer. 2020 Dec;19(4):285-290. doi: 10.1016/j.clcc.2020.06.003. Epub 2020 Jun 12.

  PMID: 32921581 RESULT

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis

Interventions

IFL protocol; aflibercept

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Mrs Karine Le Malicot, Head of biostatistics
• Organization: FFCD

karine.le-malicot@u-bourgogne.fr

+33 3 80 39.34.79

Study Officials

• Julien TAIEB, PhD

  Fédération Francophone de Cancérologie Digestive

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2014
• First Posted: July 4, 2014
• Study Start: October 1, 2014
• Primary Completion: February 1, 2017
• Study Completion: July 1, 2017
• Last Updated: June 7, 2021
• Results First Posted: June 7, 2021

Record last verified: 2021-05

Locations

FR (8)