Metastatic pancreatic cancer MedDRA version: 18.0 Level: LLT Classification code 10033605 Term: Pancreatic cancer metastatic System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Oxaliplatino
Product Name: Oxaliplatino
Product Code: 71555
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: OXALIPLATIN
CAS Number: 61825-94-3
Current Spons
Sponsors
Grupo de Tratamiento de los Tumores Digestivos (TTD)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologically and/or cytologically confirmed pancreatic adenocarcinoma - Stage IV disease (metastatic pancreatic cancer). - No prior systemic therapy for their diagnosis (except in adjuvant setting with or without radiotherapy during previous six months. - ECOG performance status of 0-1 - At least 18 years of age - RECIST versión 1.1. defined measurable disease - Female patients must be either surgically sterile or postmenopausal, or if of childbearing potential must have a negative pregnancy test (serum or urine) prior to enrollment and agree to use effective barrier contraception during the period of therapy. Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are therefore not considered effective for this study. Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the investigator. - Adequate bone marrow function: ANC = 1500/uL Platelet count =100,000/uL Hemoglobin = 9.0 g/dL - Adequate hepatic function: Total bilirubin = 1.5 X ULN or until 2mg/dL AST (SGOT) = 2.5 X ULN = 5 X ULN if liver metastases ALT (SGPT) = 2.5 X ULN = 5 X ULN if liver metastases Adequate renal function as determined by either: - Calculated or measured creatinine clearance = 40 mL/min (for calculated creatinine clearance, Cockroft-Gault equation will be used) - Ability to understand the nature of this study protocol and give written informed consent. - Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: - History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that, in the opinion of the investigator, renders the subject at high risk from treatment complications or might affect the interpretation of the results of the study. - Presence of central nervous system or brain metastases. - Life expectancy grade 1. - Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months. - Major surgery within 4 weeks of the start of study treatment, without complete recovery. - Prior malignancy except for adequately treated basal cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other form of cancer from which the patient has been disease-free for 5 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Phase I: - To determine the safety DLT for the AG-mFOLFOX combination. Phase II: - Clinical efficacy of AG-mFOLFOX vs AG as measured as % of overall survival al 12 months after treatment initiation.;Secondary Objective: Phase I: - Efficacy of the AG-mFOLFOX in terms of response rate. Phase II: - Overall survival at 6 months - Overall survival at 24 months - Time to tumor progression - Progression free survival - Overall survival - Objective radiographic response (ORR) - CA 19-9 biomarker response - Safety profile of this combination (AG-mFOLFOX) - Quality of Life of the patients;Primary end point(s): Phase I: To determine the safety DLT for the AG-mFOLFOX combination defined by: - Grade 3 - 4 non-haematological toxicity (except hypersensitive reactions; in case of grade 3 diarrhoea or emesis dose limitations will only be considered if these occur in spite of receiving optimal out-patient medical treatment) - Grade 4 haematological toxicity (grade 4 thrombocytopenia ( 38ºC) - Any toxicity requiring a 2-week delay between cycles is also considered dose limiting. Phase II: - Overall survival al 12 months after treatment initiation.;Timepoint(s) of evaluation of this end point: Phase I: - To determine the safety DLT: during study treatment. Phase II: - Overall survival al 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Phase I: - Overall response rate. Phase II: - Overall survival at 6 and 24 months. - Time to tumor progression. - Progression free survival. - Overall survival. - Objective radiographic response (ORR). - CA 19-9 biomarker response. - Safety profile using NCI-CTCAE v.4 criteria - Quality of Life of the patients through the EORTC QLQ-C30 and EORTC QLQ-CIPN20 questionnaires;Timepoint(s) of evaluation of this end point: PFS: date of disease progression or death for any reason (what happens first)TTP: date of disease progression OS: date of death for any reason ORR, CA 19-9, Safety and QoL: during treatment and follow-up period (if applicable) | — |
Countries
Spain
Contacts
Public ContactAna Sotés Mendiola
Dynamic Science
Outcome results
None listed