Pancreatic Cancer MedDRA version: 21.1 Level: LLT Classification code 10033605 Term: Pancreatic cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.0 Level: LLT Classification code 10033606 Term: Pancreatic cancer non-resectable System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Abraxane
Pharmaceutical Form: Infusion
INN or Proposed INN: PACLITAXEL ALBUMIN-BOUND
Other descriptive name: PACLITAXEL ALBUMIN-BOUND
Concentration unit: mg/ml milligram(s)/millilitre
Conc
Sponsors
Aalborg University Hospital, Department of Oncology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age = 18 years • Adenocarcinoma of the pancreas, histopathologically or cytologically verified • Non-resectable (locally advanced or metastatic) pancreatic cancer • Patients unfit or not candidate for full-dose combination chemotherapy • Patients eligible for full dose gemcitabine or reduced dose combination chemotherapy • Performance status = 2 • Measurable or non-measurable disease • Adequate hematologic function defined as absolute neutrophil count (ANC) = 1.5x109/l and platelets count = 100x109/l within 2 weeks prior to enrollment • Adequate organ function (bilirubin = 1.5 x UNL (Upper normal limit) and eGFR > 50ml/min within 2 weeks prior to enrollment • Toxicity of prior chemotherapy, including neurotoxicity, resolved to CTCAE =65 years) yes F.1.3.1 Number of subjects for this age range 68
Exclusion criteria
Exclusion criteria: • Patients eligible for downstaging/preoperative chemotherapy followed by resection or local ablation or irradiation • Prior chemotherapy for pancreatic cancer (However, patients treated with adjuvant therapy with recurrence occurring more than 6 months after end of this treatment are eligible) • Concurrent, non-curatively treated malignant neoplasm other than pancreatic adenocarcinoma • Concurrent treatment with any other anti-cancer therapy • Pregnant or breast-feeding patients • Patients clearly intending to withdraw from the study if not randomized in the willing arm or patients who cannot be regularly followed up for psychological, social, familiar, or geographic reasons. • Other condition or therapy, which in the investigator’s opinion may pose a risk to the patient or interfere with the study objectives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main aim of the trial is to investigate whether the best treatment, in relation to progression free survival, is to give full dose standard chemotherapy (gemcitabine) or reduced dose combination chemotherapy (gemcitabin plus nab-paclitaxel) to frail patients with non-resectable pancreatic cancer;Secondary Objective: We also want to investigate whether the best treatment, in relation to overall survival and response rate is to give full dose standard chemotherapy (gemcitabine) or reduced dose combination chemotherapy (gemcitabin plus nab-paclitaxel) to frail patients with non-resectable pancreatic cancer. Moreover to investigate the number of hospitalizations, quality of life and cumulative worst toxicity during treatment.;Primary end point(s): Progression free survival;Timepoint(s) of evaluation of this end point: When the trial has completed | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Overall Survival Response rate Number of hospitalizations during treatment Quality of life Cumulative worst toxicity during treatment ;Timepoint(s) of evaluation of this end point: When the trial has completed | — |
Countries
Denmark
Contacts
Public ContactDepartment of Oncology
Aalborg University Hospital
Outcome results
None listed