Low dose cyclophosphamide +/- nintedanib in advanced ovarian cancer
Research type
Research Study
Full title
Phase II, randomised, placebo controlled, multicentre, feasibility study of low dose (metronomic) cyclophosphamide with or without nintedanib (BIBF 1120) in advanced ovarian cancer (METRO-BIBF)
IRAS ID
84472
Contact name
Marcia Hall
Contact email
Sponsor organisation
University College London
Eudract number
2011-005814-12
Clinicaltrials.gov Identifier
Research summary
This is a randomized Phase II study addressing the benefit of adding nintedanib to oral cyclophosphamide (standard of care) in women with recurrent ovarian cancer, combining two anti-angiogenic strategies. The approach uses two oral drugs that have relatively low toxicity.
We plan to recruit 124 women with advanced recurrent ovarian cancer, who have completed at least two lines of chemotherapy and who are not suitable for further ‘standard’ intravenous chemotherapy treatments. They will receive cyclophosphamide taken once daily and nintedanib capsules or placebo capsules taken twice daily. The trial medication will be given continuously until disease progression, death or unacceptable toxicity. Medication is dispensed to the patient on day 1 of a 6 week cycle.
All patients will have imaging and CA125 measurements at baseline as well as completing relevant Quality of Life (QoL) questionnaires. The first 12 patients randomised in this study will be assessed for toxicity 3 weekly for the first 12 weeks. Once the Independent Data Monitoring Committee have evaluated the toxicities in these first 12 patients, further randomised patients will be seen every 6 weeks. Assessments will include CA125 measurements and Quality of Life (QOL)assessments every 6 weeks. Imaging will be repeated every 3 months.
The trial will recruit for approximately 18 months.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
13/EM/0266
Date of REC Opinion
17 Aug 2013
REC opinion
Further Information Favourable Opinion