Pharmacogenomics guided dosing for fluoropyrimidine and irinotecan chemotherapies for patients with cancer (PACIFIC-PGx)

Not Applicable

Active, not recruiting

• Conditions: Gastrointestinal cancers; Breast cancer; Head and neck cancer; Cancer - Oesophageal (gullet); Cancer - Bowel - Anal; Gynaecological cancers; Urogenital cancers; Cancer - Breast; Cancer - Biliary tree (gall bladder and bile duct); Cancer - Bladder

• Registration Number: ACTRN12621000251820
• Lead Sponsor: Peter MacCallum Cancer Centre

Brief Summary

Interim results 1. 493 patients recruited over 12-months from 4 Australian sites (a large metropolitan specialist cancer centre (Peter Mac) and 3 regional centres (Bendigo Health, Border Medical Oncology and Swan Hill District Health)). 2. 4% of patients were DPYD intermediate metabolisers requiring upfront dose reduction 3. 8% of patients were UGT1A1*28 poor metabolisers requiring upfront dose reduction 4. 96% of gene test results (for DPYD and UGT1A1*28) reported prior to cycle 1, allowing us to dose adjust prior to patients commencing fluoropyrimidines or irinotecan to prevent severe toxicities. 5. Average days from sample collection to reporting of gene test results: a. Approx. 5 days for DPYD genotyping b. 7 days for UGT1A1*28 genotyping Overall the trial was shown to be feasible

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-08
• Last Update Posted: 1 April 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 493

Inclusion Criteria

1.Aged 18 years or older
2.First time exposure to fluoropyrimidine and/or irinotecan chemotherapy for cancer treatment (any line of treatment, any cancer diagnosis, any stage of disease).
3.Previously enrolled patients in the Peter Mac Pharmacogenetics Screening Program, for purpose of consenting for collection and storage of research samples for future genomic testing.

Exclusion Criteria

1.Patients that have had prior exposure to fluoropyrimidine and irinotecan, other than those previously enrolled in the Peter Mac Pharmacogenetics Screening program who are included only for research sample collection.
2.Patients with known DPD deficiency or Gilberts’ syndrome
3.Patients undergoing cytoreduction surgeries and HIPEC planned to receive HIPEC, single dose 5-fluorouracil

Study & Design

• Study Type: Interventional
• Study Design: Not specified