A study to assess if pantoprazole affects the absorption of capecitabine in patients with breast and gastrointestinal cancers.

Phase 1

• Conditions: Breast Cancer; Gastrointestinal Cancer; colorectal cancer; Cancer - Breast; Cancer - Bowel - Back passage (rectum) or large bowel (colon); Cancer - Bowel - Small bowel (duodenum and ileum)

• Registration Number: ACTRN12620001317987
• Lead Sponsor: Auckland District Health Board

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-07
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

adults (18+ years) with histologically confirmed GI or breast cancer, receiving adjuvant or palliative capecitabine monotherapy within the Regional Cancer and Blood Services, Auckland District Health Board. Adequate functional status (ECOG 2 or less) and organ function as defined as (i) Neutrophil>1.5, Hb>9g, Platelet>100,000, (ii) Bilirubin<1.5x ULN, ALT, AST <2.0 ULN, (iii) Creatinine clearance calculated by Cockcroft Gault >50ml/min within 14 days of cycle 1.

Exclusion Criteria

Previous capecitabine use, recent Proton pump inhibitors (PPI), /H2 Receptor Blocker or antacid use, pre-existing gastritis/ gastro-oesophageal reflux necessitating treatment, previous intolerance to PPI and any condition deemed by study investigators to significantly affect normal gastrointestinal tract function (e.g. upper gastrointestinal tract surgery/ radiation/ pre-existing condition)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Area Under the Curve AUC(0-8) of 5”DFUR (Blood and urine sample) [Cycle 1 Day 1: pre-dose, 0.25, 0,5, 1, 1.5, 2, 3, 4, 6, 8 hours post-ingestion of pantoprazole, Cycle 2 Day 1: pre-dose, 0.25, 0,5, 1, 1.5, 2, 3, 4, 6, 8 hours post-ingestion of pantoprazole];Area Under the Curve AUC(0-8) of 5-FU (blood and urine sample) [Cycle 1 Day 1: pre-dose, 0.25, 0,5, 1, 1.5, 2, 3, 4, 6, 8 hours post-ingestion of pantoprazole, Cycle 2 Day 1: pre-dose, 0.25, 0,5, 1, 1.5, 2, 3, 4, 6, 8 hours post-ingestion of pantoprazole]