Low dose chemotherapy for metastatic pancreatic cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of a low dose OXIRI regimen, which combines metronomic oxaliplatin and capecitabine with UGT1A1 genotype-directed dosing of irinotecan, in patients with metastatic pancreatic cancer. Conducted at the National Cancer Centre in Singapore, the trial is non-randomized and open-label, enrolling patients in two stages to evaluate response and toxicity. Eligible participants will receive the treatment until disease progression or unacceptable toxicity occurs, followed by a post-treatment follow-up period of up to 24 months.

Why it matters

Who can join: the full rules

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.

Where it's running

• National Cancer Centre, Singapore
  Singapore, Singapore Recruiting

Study contacts

• Principal investigator: Dr Joycelyn LEE, MBBS, MRCP (UK), M Med — National Cancer Centre, Singapore
• Study coordinator: Dr Joycelyn LEE, MBBS, MRCP (UK), M Med
• Email: joycelyn.lee.j.x@singhealth.com.sg
• Phone: +65 64368000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.