Metastatic pancreatic cancer MedDRA version: 17.1 Level: PT Classification code 10033610 Term: Pancreatic carcinoma metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Abraxane
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: nab-paclitaxel
CAS Number: 33069-62-4
Ot
Sponsors
Asociación de Oncología Médica del Hospital de Cruces (ASONMEC)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically or citologically-confirmed pancreatic adenocarcinoma 2. Stage IV disease (metastatic only) 3. No prior systemic therapy for their diagnosis (except in adjuvant setting > six months previously) 4. ECOG performance status of 0-1 5. Age >=70 years. 6. Evidence of either or both of the following: - RECIST-defined measurable disease (lesions that can be accurately measured in at least one dimension with the longest diameter >= 20mm using conventional techniques or >= 10 mm with spiral CT scan) - An elevated serum CA19-9 at baseline ( >= 2X ULN) 7. Female patients must be either surgically sterile or postmenopausal. 8. Male patients must be surgically sterile or must agree to use a condom during sex with women who may become pregnant while receiving the study drug and for 6 months after receiving the last dose. 9. Adequate bone marrow function: - ANC >= 1500/uL - platelet count >= 100,000/uL - hemoglobin >= 9.0 g/dL 10. Adequate hepatic function: - Total bilirubin = 40 mL/min (for calculated creatinine clearance, Cockroft-Gault equation will be used). 12. Ability to understand the nature of this study protocol and give written informed consent 13.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) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80
Exclusion criteria
Exclusion criteria: 1. Any prior systemic or investigational therapy for metastatic pancreatic cancer. 2. Inability to comply with study and/or follow-up procedures. 3. 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. 4. Presence of central nervous system or brain metastases. 5. Life expectancy grade 1. 12. Major surgery within 4 weeks of the start of study treatment, without complete recovery. 13. Concurrent/pre-existing use of coumadin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of treatment through 3-months deterioration free rate; Secondary Objective: - 3 months progression free survival - Safety profile of this combination using NCI-CTCAE v.4 criteria - Time to tumor progression - Overall survival - Objective radiographic response (ORR) - CA 19-9 biomarker response ; Primary end point(s): 3-months deterioration free rate: % patients free from definitive deterioration. TUDD (Time Until Definitive Deterioration) is defined as the time from randomization to the first observation of a definitive deterioration of the score. A definitive deterioration is considered when the score decreases by more than 10 points as compared to baseline. EORTC QLQ-C30 will be used to calculate TUDD (Time Until Definitive Deterioration). EORTC QLQ-C30 scores will be calculated every four weeks. ;Timepoint(s) of evaluation of this end point: Every 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - 3 months progression free survival - Safety profile of this combination using NCI-CTCAE v.4 criteria - Time to tumor progression - Overall survival - Objective radiographic response (ORR) - CA 19-9 biomarker response ; Timepoint(s) of evaluation of this end point: - 3 months - every 4 weeks - every 8 weeks - every 8 weeks - every 8 weeks - every 4 weeks | — |
Countries
Spain
Contacts
Public ContactDepartamento Operaciones Clínicas
APICES SOLUCIONES, S.L.
Outcome results
None listed