Participants start FOLFIRINOX. They will also begin digoxin and take it up to 4-5 months time period in patients with resectable pancreatic cancer. Digoxin is taken at the time of neo-adjuvant chemotherapy treatment, prior to surgery. After surgery, participants will continue with post-adjuvant chemotherapy.

Pancreas Cancer

Adenocarcinoma of the Pancreas

Digoxin

5-FU will be given as a 46 hour continuous IV infusion

5Fluorouracil

Calcium Leucovorin

Irinotecan

Oxaliplatin

FOLFIRINOX With Digoxin in Patients With Resectable Pancreatic Cancer

A Phase IIa (Pilot) Study of Neoadjuvant Chemotherapy With Folinic Acid, 5-FU, Irinotecan and Oxaliplatin (FOLFIRINOX) With Digoxin in Patients With Resectable Pancreatic Cancer

Regimen will be considered for further investigation if 14 of the 20 patients are able to undergo resection

Continuous monitoring will be performed to monitor toxicity using Pocock stopping boundary that yields the probability of crossing the boundary at most 0.05 when the toxicity rate is equal to 0.182 or 0.28 separately.

Jean Grem, MD

Principal Investigator

National Cancer Institute (NCI)

Aflibercept 4 mg/kg administered over 1 hour on Day 1, followed by FOLFIRI regimen. Treatment will be repeated every 2 weeks. FOLFIRI regimen: Irinotecan 180 mg/m² intravenous (IV) infusion and folinic acid 400 mg/m² IV infusion followed by: 5-fluorouracil (5-FU) 400 mg/m² IV bolus followed by: 5-FU 2400 mg/m² continuous IV infusion over 46 hours. FOLFIRI administration will immediately follow the aflibercept one. In the absence of PD after 6 months of the combination of chemotherapy and aflibercept, the patient will be treated with a maintenance therapy with aflibercept alone until PD or unacceptable toxicities, investigator's decision or patient's refusal of further treatment or death, whichever comes first.

Metastatic Colorectal Cancer

AFLIBERCEPT

5-Fluorouracil

Folinic Acid

Agios Georgios Chania General Hospital

2nd Dept of Internal Medicine, Agios Savvas Cancer Hospital

251 Airforce Hospital

2nd Dept of Internal Medicine, General Hospital of Athens "Hippokratio"

Oncology Unit, 3rd Dept of Internal Medicine, Athens School of Medicine, Sotiria General Hospital

Oncology Section, Dept of Clinical Therapeutics, General Hospital of Athens "Alexandra"

Division of Oncology, 2nd Dept of Internal Medicine, University Hospital "Attiko"

2nd Dept of Medical Oncology, Agii Anargiri Cancer Hospital

3rd Dept of Medical Oncology, Agii Anargiri Cancer Hospital

3rd Dept of Medical Oncology, Hygeia Hospital

1st Dept of Medical Oncology, Metropolitan Hospital

2nd Dept of Medical Oncology, Metropolitan Hospital

Dept of Medical Oncology, University Hospital of Heraklion

Dept of Medical Oncology, Ioannina University Hospital

Oncology Dept, University Hospital of Larissa

Division of Oncology, Dept of Internal Medicine, University Hospital of Patras

Thermi Clinic S.A.

Dept of Medical Oncology, Papageorgiou General Hospital

﻿Clinical Trial of Combination Chemotherapy With Aflibercept in Patients With Advanced Colorectal Cancer

﻿Single-arm Phase II Study of Maintenance Therapy With Aflibercept After First-line Treatment With FOLFIRI Plus Aflibercept in Metastatic Colorectal Cancer Patients

Response to treatment will be described in a frequency table along with the corresponding percentages and 95% exact confidence intervals.

Adverse Events of the safety population for the FOLFIRI-aflibercept treatment part and the maintenance therapy will be presented in frequency tables according to grade, along with the corresponding percentages (N,%)

Hellenic Cooperative Oncology Group

Sanofi

folinic acid

hypoxia

folinic acid/hypoxia

FOLFIRINOX With Digoxin in Patients With Resectable Pancreatic Cancer

Clinical Trial of Combination Chemotherapy With Aflibercept in Patients With Advanced Colorectal Cancer

Išsamiausia vaistinių žolelių duomenų bazė, paremta mokslu

folinic acid/hypoxia

FOLFIRINOX With Digoxin in Patients With Resectable Pancreatic Cancer

﻿Clinical Trial of Combination Chemotherapy With Aflibercept in Patients With Advanced Colorectal Cancer

Išsamiausia vaistinių žolelių duomenų bazė, paremta mokslu

Clinical Trial of Combination Chemotherapy With Aflibercept in Patients With Advanced Colorectal Cancer