Gemcitabine Versus Reduced-dose Combination Chemotherapy in Fragile Patients With Non-resectable Pancreatic Cancer

• Status: Not yet recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Morten Ladekarl
• Collaborators: Aarhus University Hospital; Gødstrup Hospital; Herlev and Gentofte Hospital; Odense University Hospital; Vejle Hospital
• Treatments: Gemcitabine; Paclitaxel

Criteria

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- 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)