A Randomized Phase II Study of Gemcitabine Versus Reduced-dose Combination Chemotherapy in Fragile Patients with Non-resectable Pancreatic Cancer
The aim of the study is to compare the efficacy and toxicity of full-dose Gemcitabine and reduced-dose combination chemotherapy in patients with non-resectable pancreatic cancer, who are unfit for full-dose combination chemotherapy. The patients will be equally randomized to arm A or arm B: Arm A: Full-dose single agent treatment with Gemcitabine 1000 mg/m2 weekly on days 1, 8,and 15 every 4 weeks. Arm B: Reduced-dose (80%) combination-treatment with Gemcitabine plus Nab-Paclitaxel (Gemcitabine: 800 mg/m2 plus Nab-Paclitaxel: 100 mg/m2 on day 1, 8 and 15 every 4 weeks) Progression-free survival, overall survival and response rate will be estimated for each group, as well as toxicity and quality of life will be prospectively registered.
• Age ≥ 18 years
• Adenocarcinoma of the pancreas, histopathologically or cytologically verified
• Non-resectable (locally advanced or metastatic) PC
• Patients unfit or not candidate for full-dose combination chemotherapy
• Patients eligible for full dose gemcitabine or reduced dose combination chemotherapy
• Performance status (PS) ≤2
• Measurable or non-measurable disease
• Adequate hematologic function defined as absolute neutrophil count (ANC) ≥1.5 x 10\^9/l and platelets count ≥100x10\^9/l within 2 weeks prior to enrollment
• Adequate organ function (bilirubin ≤1.5 x UNL (Upper Normal Limit) and eGFR (estimated Glomerular Filtration Rate) \>50ml/min within 2 weeks prior to enrollment
• Toxicity of prior chemotherapy, including neurotoxicity, resolved to CTCAE \<grade 2
• Oral and written informed consent must be obtained according to the local Ethics committee requirements
• Fertile patients must use adequate contraceptives