Low dose chemotherapy for metastatic pancreatic cancer
A Phase II Study of Metronomic Capecitabine, Oxaliplatin and UGT1A1 Genotype-directed Irinotecan in Metastatic Pancreatic Cancer Patients.
This study is testing a low dose combination of chemotherapy drugs to see if it can help people with metastatic pancreatic cancer feel better and manage their disease.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 21 Years to 99 Years |
| Sex | All |
| Sponsor | National Cancer Centre, Singapore Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Singapore) |
| Trial ID | NCT05929885 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 21 with advanced, measurable pancreatic cancer not suitable for curative surgery.
Not a fit: Patients with a history of other malignancies or those with inadequate organ function may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment approach could improve response rates and tolerability for patients with advanced pancreatic cancer.
How similar studies have performed: While the specific combination of treatments in this trial is novel, similar approaches using metronomic chemotherapy have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Singapore
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.