A Randomized Phase II Study of Gemcitabine Versus Reduced-dose Combination Chemotherapy in Fragile Patients with Non-resectable Pancreatic Cancer

Trial ID: NCT05841420

Interventional - Phase 2 - Recruiting

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.

Conditions

• Pancreas Cancer
• Non-Resectable Pancreas Carcinoma

Interventions

• Gemcitabine
• Nab paclitaxel

Eligibility

Inclusion criteria

• 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

Exclusion criteria

• Patients eligible for downstaging/preoperative chemotherapy followed by resection or local ablation or irradiation
• Prior chemotherapy for PC (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.
• Known allergy or intolerance to any of the drugs used in DPCG-01 (Gemcitabine, S1 or Nab-Paclitaxel)

Sponsor

Morten Ladekarl, Aarhus University Hospital, Odense University Hospital, Herlev and Gentofte Hospital, Gødstrup Hospital, Vejle Hospital

Source: ClinicalTrials.gov

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