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Brief Title: Saracatinib and Paclitaxel in Platinum-resistant Ovarian Cancer
Official Title: A Randomised Placebo-controlled Trial of Saracatinib (AZD0530) Plus Weekly Paclitaxel in Platinum Resistant Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Study ID: NCT01196741
Brief Summary: The purpose of this study is to investigate whether the addition of the Src inhibitor saracatinib (AZD0530) to weekly paclitaxel improves efficacy, compared with paclitaxel plus placebo, in patients with relapsed platinum-resistant ovarian cancer. The trial will also determine toxicity and ascertain whether the combination of paclitaxel plus saracatinib should proceed to a phase III trial.
Detailed Description: A multicentre, randomised, double-blind, placebo-controlled Phase II trial will be conducted. The overall aim of the trial is to investigate whether the addition of saracatinib to weekly paclitaxel improves efficacy, as measured by progression free survival, compared with paclitaxel plus placebo. The trial will also determine toxicity and ascertain whether the combination of paclitaxel plus saracatinib should proceed to a phase III trial. The toxicity data from Study NCT00610714 (D8180C00015) suggests that a small number of patients could experience febrile neutropaenia during their first chemotherapy cycle. To combat this, saracatinib (175 mg OD)/matched placebo will begin 1 week prior to commencement of chemotherapy, and be given continuously until progression. All patients will receive cycles of weekly paclitaxel chemotherapy. One cycle will consist of weekly paclitaxel (80 mg/m2) for 6 weeks followed by 2 weeks rest. If there is evidence of on-going response after 4 cycles, 3 further cycles of saracatinib/placebo plus weekly paclitaxel will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Addenbrooke's Hospital, Cambridge, Cambridgeshire, United Kingdom
St Bartholomew's Hospital, London, Greater London, United Kingdom
University College London Hospital, London, Greater London, United Kingdom
Guy's Hospital, London, Greater London, United Kingdom
The Royal Mardsen Hospital, London, Greater London, United Kingdom
The Christie NHS Foundation Trust, Manchester, Greater Manchester, United Kingdom
Mount Vernon Hospital, Rickmansworth, Middlesex, United Kingdom
The Churchill Hospital, Oxford, Oxfordshire, United Kingdom
Queen's Hospital, Burton upon Trent, Staffordshire, United Kingdom
Royal Marsden Hospital, Sutton, Surrey, United Kingdom
St James's University Hospital, Leeds, Yorkshire, United Kingdom
Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom
Name: Iain McNeish
Affiliation: Barts and the London NHS Trust
Role: PRINCIPAL_INVESTIGATOR