Dose Individualization of Chemotherapy in Patients With Gastrointestinal Cancers Lacking a Specific Liver Enzyme

Launched by UNICANCER · Jun 20, 2024

Keywords

ClinConnect Summary

This clinical trial is looking to find the best way to adjust the dose of a chemotherapy drug called fluoropyrimidine for patients with digestive cancers, like colorectal cancer, who have a specific liver enzyme deficiency known as DPD deficiency. The main goal is to determine how much lower the dose should be for these patients to ensure they receive safe and effective treatment. Participants in this study will receive the adjusted chemotherapy dose and will visit the clinic every 2-3 weeks for check-ups and to monitor any side effects.

To be eligible for this trial, participants need to be adults aged 18 and older who are starting chemotherapy for gastrointestinal cancer and have not previously been treated with fluoropyrimidine. They should also be in good health overall and able to follow the study's requirements. Throughout the trial, participants can expect regular visits to the clinic and support from the medical team as they undergo treatment. It's important to note that individuals with certain health conditions or who are pregnant or breastfeeding cannot participate in this study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients with pre-treatment screening based on \[U\] value according to INCa/HAS recommendations.
• • 2. Eastern Cooperative Oncology Group performance status (ECOG PS) ≤2
• 3. Fluoropyrimidine-naïve patients with gastrointestinal cancer starting chemotherapy combining fluoropyrimidine (5-FU or capecitabine) and oxaliplatin whatever the context (adjuvant, neoadjuvant, palliative) including the following regimens (the most frequently prescribed in gastrointestinal cancers):
• • biweekly 5-FU and oxaliplatin (FOLFOX) +/- targeted therapy (TT)
• • three-weekly capecitabine and oxaliplatin (CAPOX) +/- TT
• • 4. Age ≥ 18 years
• • 5. Patients eligible for full standard fluoropyrimidine and oxaliplatin doses regardless of DPD deficiency
• • 6. Adequate bone marrow function (cell blood count (CBC)), estimated glomerular filtration rate (DFG) ≥ 50 ml/min, alkaline phosphatase (ALP) / aspartate aminotransferase (ASAT) / alanine aminotransferase (ALAT) ≤ 5 upper limit of normal (ULN), and bilirubin ≤ 50 micromol/L
• • 7. Patient must have signed and dated a written informed consent form prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent.
• • 8. Women of childbearing potential must have a negative serum or urine pregnancy test.
• • 9. Patients must agree to remain abstinent or use contraceptive methods with a failure rate of \< 1% per year for the duration of study treatment and within 6 months after completing treatment.
• • 10. Patients must be affiliated to a Social Security System (or equivalent).
• • 11. Patient is willing and able to comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits, and examinations including follow-up.
• Exclusion Criteria:
• • 1. Patients with complete DPD deficiency based on \[U\] ≥150 ng/mL
• • 2. Any prior treatment including a fluoropyrimidine
• • 3. Patients with any contraindication to treatment with fluoropyrimidine or oxaliplatin regardless of DPD deficiency
• • 4. Patients not eligible for full standard dose fluoropyrimidine and oxaliplatin for clinical reasons including older age and/or comorbidity regardless of a DPD deficiency
• • 5. Patients unwilling or unable to comply with trial obligations for geographic, social, or physical reasons, or who are unable to understand the purpose and procedures of the trial
• • 6. Recent or concomitant treatment with brivudine
• • 7. Pregnant or breastfeeding woman.
• • 8. Participation in another therapeutic trial within 30 days prior to inclusion.
• • 9. Persons deprived of their liberty or under protective custody or guardianship.