Comparing the Current Hydration Regimen for the ABC02 Chemotherapy Regimen Versus a Shorter Hydration

NCT04362449 | Unknown Phase 2 DMC

• 1 other identifier: 214262
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open label study for any patients with a bile duct cancer or gallbladder cancer, who will be treated with gemcitabine and cisplatin chemotherapy (the ABC02 regime). Patients recruited onto this study will have a reduction of their hydration time and be given Akynzeo as an anti-sickness drug, to assess tolerability compared to the current standard of care. The aim of this research is to assess the tolerability of a shorter hydration time, which may improve patient satisfaction as they would then spend less time in hospital having chemotherapy, saving both time and money for the institutions also.

Conditions

Gallbladder Cancer

Outcome Measures

Primary Outcomes (1)

• Nausea according to the Common Terminology Criteria for Adverse Events (CTCAE) V4.03

  To compare the proportion of patients who experience CTCAE V3.0 grade 3 or 4 nausea (using a shortened hydration protocol and a modern antiemetic regimen) with those who are in the ABC02 trial arm which used a longer hydration procedure and a standard antiemetic regimen

  Throughout study completion, up to 1 year

Secondary Outcomes (6)

• Renal function of patients

  Throughout study completion, up to 1 year

• Number of patients who have a complete response

  Throughout study completion, up to 1 year

• Number of patients with renal dysfunction

  Throughout study completion, up to 1 year

• Number of cases of chemotherapy induced emesis

  Throughout study completion, up to 1 year

• Nocturia experienced by patients

  Throughout study completion, up to 1 year

Study Arms (2)

Shortened hydration time with dispensary of Akynzeo

EXPERIMENTAL

ABC-02 regime - gemcitabine and cisplatin with a shortened hydration time and administration of a newer antiemetic

Combination Product: Shortened hydration time and dispensary of Akynzeo

Standard of care

ACTIVE COMPARATOR

ABC-02 regime - gemcitabine and cisplatin with currently approved hydration time and administration of the current choice of antiemetic

Combination Product: Standard of care

Interventions

Shortened hydration time and dispensary of Akynzeo COMBINATION_PRODUCT

Hydration is reduced to 1 hour and 40 minutes and Akynzeo is administered as an oral drug instead of Ondansetron being given as an IV before chemotherapy.

Shortened hydration time with dispensary of Akynzeo

Standard of care COMBINATION_PRODUCT

Hydration remains at around 6 hours and 30 minutes due to no oral fluids being consumed prior to treatment and normal saline being administered for 90 minutes before cisplatin and then for 2 hours after cisplatin and before gemcitabine administration

Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults with normal renal function at the start i.e. eGFR\>60, Performance status 0 and 1, controlled nausea and vomiting at baseline.
• ECOG performance status 0 or 1
• Diagnosed with either cholangio carcinoma, gallbladder cancer, pulmonary cancer or pancreatic cancer. Patients should be able to tolerate 1 litre of oral fluid pre-treatment and post treatment.
• Decision to treat with the gemcitabine and cisplatin used in the ABC02 trial.

You may not qualify if:

• Uncontrolled nausea or vomiting
• Unable to drink 1 litre of fluid

Sponsors & Collaborators

• Imperial College Healthcare NHS Trust: lead
• Chugai Pharma UK Limited: collaborator

Study Sites (1)

Imperial College Healthcare NHS Trust

London, W12 0HS, United Kingdom

RECRUITING

MeSH Terms

Conditions

Gallbladder Neoplasms

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Harpreet Wasan, MD

  Gastrointestinal Clinical Research Lead and Consultant Oncologist

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Harpreet Wasan, MD

CONTACT

0208 383 3089; h.wasan@imperial.ac.uk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2020
• First Posted: April 27, 2020
• Study Start: January 2, 2019
• Primary Completion: February 2, 2023
• Study Completion: February 2, 2023
• Last Updated: July 15, 2022

Record last verified: 2022-07

Locations

GB (1)