Metronomic Capecitabine, Oxaliplatin and UGT1A1 Genotype-directed Irinotecan in Metastatic Pancreatic Cancer Patients

Launched by NATIONAL CANCER CENTRE, SINGAPORE · Jun 29, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment approach for patients with metastatic pancreatic cancer, which is cancer that has spread beyond the pancreas and is not curable through surgery. The study will test a combination of three medications: metronomic oxaliplatin, metronomic capecitabine, and a specially adjusted dose of irinotecan depending on a specific genetic factor. The goal is to see if this low-dose treatment can effectively help patients while being easier for them to tolerate.

To participate in this trial, patients must be 21 years or older and have a confirmed diagnosis of advanced pancreatic cancer that cannot be surgically removed. They should also have a life expectancy of at least three months and meet certain health criteria regarding their blood and organ function. The trial is taking place at the National Cancer Centre in Singapore, and it will enroll patients in two stages to assess how well the treatment works and any side effects that may occur. Participants can expect close monitoring and support throughout the study.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • The patient must meet all of the inclusion criteria to participate in the study.
• • 1. Aged above 21
• • 2. Histopathological diagnosis of pancreatic cancer
• • 3. Advanced disease not amenable to curative resection (locally advanced or metastatic disease)
• • 4. Measureable disease by RECIST 1.1 criteria
• • 5. Life expectancy of at least 12 weeks
• • 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
• • 7. Adequate hematologic function (granulocyte count ≥ 1.5 × 10\*\*9/L, platelet count ≥ 100 × 10\*\*9/L),
• • 8. Adequate hepatic function (total bilirubin ≤ 1.5 x the upper limits of normal \[ULN\], AST and ALT, ALP ≤ 3 x ULN or \< 5 x ULN in case of hepatic involvement),
• • 9. Adequate renal function (creatinine clearance \> 50 mL/min) will be eligible for inclusion into the study.
• • 10. Able to provide written and informed consent
• Exclusion Criteria:
• • Any patient meeting any of the exclusion criteria at baseline will be excluded from participation.
• • 1. History of another malignancy within 5 years prior to registration. Patients with a past history of adequately treated carcinoma-in-situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and superficial transitional cell carcinoma of the bladder are eligible. Patients with a history of other malignancies are eligible if they have been continuously disease free after definitive primary treatment for at least 5 years.
• • 2. Untreated CNS metastases or leptomeningeal disease. Patients with brain metastases that have been treated, and are asymptomatic, and have been stable for 3 or more months after treatment are allowed. A baseline CT or MRI brain is only required if there is clinical suspicion of CNS involvement.
• • 3. Concurrent illness, including severe infection, that may jeopardise the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety
• • 4. Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol
• • 5. Treatment with palliative chemotherapy or radiotherapy within 4 weeks prior to enrolment into the study
• • 6. Major surgery within two weeks prior to enrolment into the study
• • 7. Patients on chronic immunosuppressive therapy
• • 8. Pregnancy, lactation or inadequate contraception. Women of childbearing potential must have a negative pregnancy test within 3 days of enrolment and agree to use a reliable means of contraception. Men must have been surgically sterilised or agree to use a barrier method of contraception
• • 9. Patients on anticoagulant therapy with vitamin K antagonists.