Octreotide as prophylaxis for lapatinib-capecitabine related diarrhoea
Research type
Research Study
Full title
A Randomised, Multicentre, Open Label, Phase II study of Prophylactic Octreotide to Prevent or Reduce the Frequency and Severity of Diarrhoea in Subjects Receiving Lapatinib with Capecitabine for the Treatment of Metastatic Breast Cancer.
IRAS ID
157044
Contact name
Peter Schmid
Contact email
Eudract number
2014-000256-28
Duration of Study in the UK
2 years, 3 months, 2 days
Research summary
A Phase II, open-label, randomised trial to see whether prophylactic administration of octreotide LAR (long-acting formulation) injection helps to prevent or reduce the frequency and severity of diarrhoea in subjects receiving lapatinib plus capecitabine for the treatment of metastatic breast cancer.
Diarrhoea is a known side effect of lapatinib and capecitabine which can impact patient quality of life and treatment compliance. Each investigator will confirm that study subjects are eligible to receive lapatinib plus capecitabine treatment in accordance with the lapatinib SPC (Summary of Product Characteristics). Patients experiencing diarrhoea within 14 days prior to first study treatment will be excluded. Approximately 140 subjects will be randomised; 70 will receive octreotide (Group A) and 70 will receive no octreotide (Group B).
Group A subjects will receive two 40mg doses of octreotide LAR, to be administered at Randomisation and the Cycle 2 visits via two 20mg injections, one into each buttock muscle. Lapatinib plus capecitabine treatment will commence one week after the first octreotide LAR injection. Three weeks later (i.e. 4 weeks after the first octreotide injection), subjects will receive a second octreotide LAR dose of 40mg in the same way.
Group B (no octreotide) subjects will commence lapatinib plus capecitabine treatment straight away.
All subjects will remain on-study for approximately 24 weeks. Mandatory study visits will occur at Cycles 2 and 4. All other visits will occur per the site’s normal standard of care.
Patients will attend follow-up visits at standard of care intervals for as long as lapatinib plus capecitabine treatment continues after the 24 weeks.
Disease assessment via CT or MRI and a dermatological exam will be done at Screening, End of Study/ Treatment Withdrawal and at standard of care frequency during the study.
Patient reported outcomes (PROs) will be collected from all patients in the form of Diarrhoea Diaries and FACIT-D questionnaires whilst on study.
REC name
London - City & East Research Ethics Committee
REC reference
14/LO/1939
Date of REC Opinion
21 Jan 2015
REC opinion
Further Information Favourable Opinion