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

ABSTRACT: Interventions: Consented participants who are scheduled for capecitabine monotherapy for breast or gastrointestinal cancer will be randomly allocated to receive concomitant oral pantoprazole 40mg daily, 4 days prior to and on the first day (total 5 doses) of either the first (group A) or second (Group B) cycle of capecitabine. Pharmacokinetic blood and urine sampling for capecitabine will be performed over eight hours on both cycle1 day 1 and cycle 2 day 1 to determine if PK parameters are different with pantoprazole. Participants will be contacted by phone a day before their course of pantoprazole begins and will receive a daily text reminder on the subsequent 4 days. A medication diary will be kept. The washout period is 21 days (in between cycle 1 day 1 and cycle 2 day 1) Primary outcome(s): 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] Study Design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Crossover;Type of endpoint: Bio-equivalence

DISEASE(S): Cancer-bowel-small Bowel (duodenum And Ileum),Gastrointestinal Cancer,Colorectal Cancer,Cancer-bowel-back Passage (rectum) Or Large Bowel (colon),Breast Cancer,Cancer-breast

PROVIDER: 2471532 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Interventions: This is a prospective study involving the collection of blood samples for the purposes of measuring circulating DNA from patients with resectable colorectal cancer liver metastases. Two distinct cohorts of patients, those undergoing initial liver resection followed by 12 cycles of FOLFOX and those given pre and postoperative chemotherapy will be treated and followed according to standard protocols. 60 mls of blood will be collected at specified timpoints. - 60 mls will be collected at each timepoint. COHORT 1 - Initial Surgery the timepoints are: Timepoint 1 - Screening Timepoint 2 - 4 weeks post surgery Timepoint 3 Post cycle 6 adjuvant chemotherapy (Day 1 Cycle 7) Timepoint 4 - Post cycle 12 (Days 3 at CADD disconnect) Timepoint 5 - 10 every 3 months (3 mth follow up; 6mth follow up; 12 mth follow up; 18 mth follow up and 24 mth follow up) COHORT 2 - Pre-op Chemo timpoints are: Timepoint 1 - Screening Timepoint 2 - Post cycle 1 (day 1 cycle 2) Timepoint 3 - Post cycle 2 (day 1 cycle 3) Timepoint 4 - post cycle 4 (day 1 cycle 5) Timepoint 5 - 4 weeks post surgery Timepoint 6 - Post cycle 12 (day 3 at CADD disconnect) Timepoint 7 -10 - 3 monthly follow - ups ( 3 mths; 6 mths; 9 mths; 12 mnths) Timepoint 11 & 12 - 6 monthly follow - ups (18 mths and 24 mths) Primary outcome(s): To demonstrate that the persistence of tumour DNA in peripheral blood immediately following clinically and radiologically complete resection of liver metastases is a sensitive and specific predictor of subsequent disease recurrence.[Final analysis of blood, plasma and tissue specimens. COHORT 1 - Initial Surgery the timepoints are: Timepoint 1 - Screening Timepoint 2 - 4 weeks post surgery Timepoint 3 Post cycle 6 adjuvant chemotherapy (Day 1 Cycle 7) Timepoint 4 - Post cycle 12 (Days 3 at CADD disconnect) Timepoint 5 - 10 every 3 months (3 mth follow up; 6mth follow up; 12 mth follow up; 18 mth follow up and 24 mth follow up) COHORT 2 - Pre-op Chemo timpoints are: Timepoint 1 - Screening Timepoint 2 - Post cycle 1 (day 1 cycle 2) Timepoint 3 - Post cycle 2 (day 1 cycle 3) Timepoint 4 - post cycle 4 (day 1 cycle 5) Timepoint 5 - 4 weeks post surgery Timepoint 6 - Post cycle 12 (day 3 at CADD disconnect) Timepoint 7 -10 - 3 monthly follow - ups ( 3 mths; 6 mths; 9 mths; 12 mnths) Timepoint 11 & 12 - 6 monthly follow - ups (18 mths and 24 mths)]

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

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