metastatic pancreatic adenocarcinoma
Conditions
Interventions
Trade Name: Abraxane
Pharmaceutical Form: Powder and solvent for concentrate for solution for infusion
INN or Proposed INN: PACLITAXEL
CAS Number: 33069-62-4
Concentration unit: mg/ml milligram(s)/mil
Sponsors
Med. Univ. Wien, Klinik f. Innere Med. I, Onkologie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with histologically or cytologically confirmed metastatic pancreatic adenocarcinoma - Radiologically determinable disease defined by RECIST version 1.1 within 4 weeks prior to study treatment initiation - ECOG performance status of 0 or 1 - Adequate hematologic function, as follows - Adequate renal function - Adequate hepatic function - Any age = 18 = 75 years - Life expectancy > 3 months at baseline - Informed consent signed prior to any study specific procedure - Ability to comply with the protocol and attended follow up - Women of childbearing potential must have a negative serum pregnancy test done 1 week prior to study drug administration. 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 16 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 16
Exclusion criteria
Exclusion criteria: - Major surgery within 4 weeks prior start of study treatment - Any past or current history of other invasive malignancies less than 5 years prior to study inclusion - Clinical suspicion of brain metastases - Patient has only locally advanced disease - Patients may not have received previous treatment for metastatic or locally advanced, non- or borderline resectable disease. Prior adjuvant treatment with Gemcitabine is allowed,though tumor recurrence must have occurred = 6 months after the last treatment. - Active infection requiring systemic treatment or any uncontrolled infections 1 o Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or IMP administration, or which, in the judgment of the investigator, would make the patient inappropriate for enrolment into this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Objective response rate of Capecitabine + Nab-Paclitaxel as first-line chemotherapy in patients with metastatic pancreatic cancer;Secondary Objective: Disease control rate, progression-free and overall survival, assessment of the safety & tolerability of this combination in mPC patients, evaluation of feasibility of an intra-individual dose escalation Nab-Paclitaxel dose regimen;Primary end point(s): Objective tumor response based on computed tomography (CT) scans (or magnetic resonance imaging [MRI] scans, if patient is allergic to contrast agent or has some other contraindication to a CT scan). These will be evaluated according to the RECIST guidelines. Interpretation of radiological response will be completed by review of CT (or MRI) scans at an independent, centralized, blinded facility. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Disease control rate (i.e., objective tumor response or stable disease for =16 weeks) - Progression-free survival (PFS) as time from initiation of chemotherapeutic treatment until disease progression - Overall survival (OS) as time from initiation of chemotherapeutic treatment to death from any cause - Occurrence of treatment related toxicities - Evaluation of feasibility of an intra-individual dose escalation Nab-Paclitaxel dose regimen | — |
Countries
Austria
Outcome results
None listed