A Study Evaluating the Efficacy of 5-FU + NALIRI and 5-FU + NALIRINOX for PDAC (NALPAC)

Launched by BELGIAN GROUP OF DIGESTIVE ONCOLOGY · Jul 22, 2022

Keywords

ClinConnect Summary

This clinical trial, called NALPAC, is studying two different treatment combinations for patients with advanced pancreatic cancer that has continued to grow after previous treatments. The treatments being tested are a combination of a drug called 5-FU with NALIRI and another combination of 5-FU with NALIRINOX. The goal is to see how effective these treatments are in slowing down or stopping the cancer from worsening.

To participate in this trial, patients must be at least 18 years old and have a confirmed diagnosis of metastatic pancreatic cancer, meaning the cancer has spread beyond the pancreas. They should have experienced cancer progression after receiving certain previous treatments. Participants need to be in relatively good health, with certain blood test results showing their organs are functioning well. The trial is currently recruiting participants, and those who join can expect close monitoring by medical professionals throughout the study to assess how well the treatments are working. It's important for potential participants to understand that they will need to sign a consent form and meet specific health criteria to be eligible for this trial.

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Eligibility criteria

• Inclusion Criteria:
• • Histologically proven metastatic adenocarcinoma of the pancreas
• • Progression documented after gemcitabine-Abraxane, or gemcitabine monotherapy
• • Signed written informed consent
• • Age ≥ 18
• • ECOG PS 0/1 at study entry
• • Measurable disease
• • Adequate renal (serum creatinine ≤ 1.5x upper reference range), liver (total bilirubin ≤ 1.5x upper reference range) and hematopoietic functions (PMN ≥ 1,5x109/L, platelets ≥ 100x109/L, hemoglobin ≥ 9g/dl)
• • INR/PTT ≤ 1.5x ULN
• • Life expectancy of at least 12 weeks
• • Effective contraception for both male and female patients if the risk of conception exists during treatment and for one month after the last administration
• • Peripheral Neuropathy \< grade 2
• Exclusion Criteria:
• • Uncontrolled concurrent CNS, cardiac, infectious diseases, hypertension
• • History of myocardial infarction, deep venous or arterial thrombosis, CVA during the last 6 months
• • Known hypersensitivity to any of the components, including excipients, of study treatments
• • Previous malignancy in the last past 3 years except basal cell cancer of the skin or preinvasive cancer of the cervix or carcinoma in situ of any type
• • Pregnancy or breast feeding
• • Medical or psychological conditions that would not permit the patient to complete the study or sign inform consent
• • Unstable angina, congestive heart failure ≥NYHA class II
• • Uncontrolled hypertension despite optimal management (systolic blood pressure \>150 mmHg or diastolic pressure \> 90mmHg)
• • HIV infection
• • Complete DPD deficiency
• • Liver failure, cirrhosis Child Pugh B or C
• • Active chronic hepatitis B or C with a need for antiviral treatment
• • Brain metastasis
• • Major surgery, open biopsy or significant traumatic injury within 4 weeks prior to the first dose of treatment
• • History of organ allograft
• • Ongoing uncontrolled, serious infection
• • Renal failure requiring dialysis
• • Patients receiving or having received any investigational treatment within 4 weeks prior to study entry, or participating to another clinical study