EndoTAG-1+GEM vs GEM in Patients With Locally Advanced/Metastatic Pancreatic Adenocarcinoma Failed on FOLFIRINOX
Metastatic Pancreas Cancer, Locally Advanced Pancreatic Cancer, Pancreatic Adenocarcinoma
About this trial
This is an interventional treatment trial for Metastatic Pancreas Cancer focused on measuring FOLFIRINOX, 5-Fluorouracil, folinic acid, irinotecan, oxaliplatin, Gemcitabine
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years
- Written informed consent
- Histologically or cytologically confirmed adenocarcinoma of the pancreas
- Metastatic or locally advanced disease that is considered unresectable
- Measurable / assessable disease according to RECIST v.1.1
- Documented disease progression on first line FOLFIRINOX
- Negative pregnancy test
- Both male and female patients and their partners of childbearing potential must agree to use two medically accepted methods of contraception (e.g., barrier contraceptives [male condom, female condom, or diaphragm with a spermicidal gel], hormonal contraceptives [implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings], or one of the following methods of birth control (intrauterine devices, tubal sterilization or vasectomy) or must practice complete abstinence from intercourse of reproductive potential during the course of the study and for 90 days after last treatment (excluding women who are not of childbearing potential and men who have been sterilized).
- ECOG performance status 0 or 1
Exclusion Criteria:
- Cardiovascular disease, New York Heart Association (NYHA) III or IV
- History of severe supraventricular or ventricular arrhythmia
- History of coagulation or bleeding disorder
- History of acute myocardial infarction within 6 months before randomization
- History of congestive heart failure
- Acute or chronic inflammation (autoimmune or infectious)
- Significant active/unstable non-malignant disease likely to interfere with study assessments
Laboratory tests (hematology, chemistry) outside specified limits:
- WBC ≤ 3 x 10³/mm³
- ANC ≤ 1.5 x 10³/mm³
- Platelets ≤ 100.000/mm³
- Hb ≤ 9.0 g/dl (≤ 5.6 mmol/l)
- aPTT > 1.5 x ULN
- Serum creatinine > 2.0 mg/dl (> 176.8 μmol/l)
- AST and/or ALT > 2.5 x ULN; for patients with significant liver metastasis AST and/or ALT > 5 x ULN
- Alkaline phosphatase > 2.5 x ULN
- Total bilirubin > 2 x ULN
- Albumin < 2.5 g/dL
- Clinically significant ascites
- Any anti-tumor treatment (except FOLFIRINOX as the first-line therapy) for pancreatic adenocarcinoma before enrollment. Note: Patients who have undergone surgical interventions for pancreatic adenocarcinoma will be eligible.
- Any radiotherapy for pancreatic adenocarcinoma before enrollment except for treatment of bone metastases if target lesions are not included in the irradiated field
- Major surgery < 4 weeks prior to enrollment
- Pregnant or nursing
- Investigational medicinal product < 4 weeks of enrollment
- Documented HIV history
- Active hepatitis B infection requiring acute therapy Note: Subjects infected by the hepatitis B virus will be eligible for the study if they have no signs of hepatic decompensation and meet the liver function tests eligibility criteria.
- Known hypersensitivity to any component of the EndoTAG-1 and/or gemcitabine formulations
- History of malignancy other than pancreatic cancer < 3 years prior to enrollment, except nonmelanoma skin cancer or carcinoma in situ of the cervix treated locally
- Vulnerable populations (e.g. subjects unable to understand and give voluntary informed consent)
Sites / Locations
- Compassionate Cancer Care Medical Group, Inc
- Emory University Hospital
- John B. Amos Cancer Center / IACT Health
- Orchard Healthcare Research (OHR) Inc.
- Investigator Clinical Research Centers of Indiana
- Cotton O'Neil Cancer Center (Stormont-Vail Cancer Center)
- Karmanos Cancer Institute
- Henry Ford Hospital
- North Mississippi Hematology & Oncology Associates, Ltd.
- Southeast Nebraska Cancer Center (SNCC) - Central Clinic - Main Clinic
- Guthrie - Corning Hospital - Guthrie Cancer Center
- Charleston Cancer Center
- The Center for Cancer and Blood Disorders
- Scott & White Vasicek Cancer Treatment Center
- Renovatioclinical
- University of Virginia Hospital
- CHU Angers
- CHRU - Besançon
- Hopital Haut Leveque
- CHRU Brest - Hôpital Morvan
- Centre Hospitalier de Cholet
- Centre Georges François Leclerc
- Centre Hospitalier Départemental
- Hôpital Privé Jean Mermoz
- La Timone
- Institut de Cancérologie de Lorraine
- Centre Antoine-Lacassagne
- Hopital La Pitié Salpétrière
- CH Saint Jean
- Centre Eugène Marquis
- Clinique Sainte Anne/Strasbourg Oncologie Leberale
- Dél-pesti Centrumkórház - Országos Hematológia és Infektológia Intézet
- Magyar Honvédség Egészségügyi Központ
- Országos Onkológiai Intézet
- Bács-Kiskun Megyei Kórház Onkoradiológiai Központ
- Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház
- Pécsi Tudomány Egyetem Onkoterápiás Intézet
- Oncology Department, Hillel Yafe MC
- Rambam Health Center
- Meir Medical Center
- Rabin MC
- Tel Aviv Sourasky Medical Center
- Chungnam National University Hospital
- National Cancer Center
- Inha University Hospital
- Chonnam National University Hwasun Hospital
- CHA Bundang Medical Center
- Korea University Guro Hospital
- Samsung Medical Center
- Severance Hospital
- Ajou University Hospital
- Arkhangelsk Clinical Oncological Dispensary
- Kursk State Clinical Oncology Dispensary
- Federal State Budgetary Scientific Institution "Russian Oncological Scientific Center named after N.N.Blokhin"
- Private clinnic "Medicine 24/7"
- Budget Institution of Healthcare of Omsk Region "Clinical Oncology Dispensary"
- State Budget Healthcare Institution "Orenburg Region Clinical Oncological Dispensary"
- State Budgetary Healthcare Institution Leningrad Regional Oncology Center
- Changhua Christian Hospital
- Chang Gung Medical Foundation - Kaohsiung Branch
- E-Da Hospital
- China Medical University Hospital
- National Cheng Kung University Hospital
- Mackay Memorial Hospital-Taipei Branch
- National Taiwan University Hospital
- Taipei Veterans General Hospital
- Tri-Service General Hospital (TSGH)
- Chang Gung Medical Foundation - Linkou Branch
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
EndoTAG-1 and Gemcitabine
Gemcitabine Monotherapy
EndoTAG-1 22 mg/m² twice weekly plus Gemcitabine 1000mg/m² once weekly for 1 cycle (8 weeks) consisting of 3 weeks of treatment and 1 week rest followed by 3 weeks of treatment and 1 week rest until any one of the following occurs: progressive disease or unacceptable toxicity or withdrawal of consent.
Gemcitabine 1000mg/m² once weekly, for 1 cycle (8 weeks) consisting of 3 weeks of treatment and 1 week rest followed by 3 weeks of treatment and 1 week rest until any one of the following occurs: progressive disease or unacceptable toxicity or withdrawal of consent.