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Brief Title: Carboplatin and Gemcitabine Hydrochloride With or Without Vandetanib as First-Line Therapy in Treating Patients With Locally Advanced or Metastatic Urinary Tract Cancer
Official Title: A Randomized Phase II Trial of Carboplatin and Gemcitabine +/- Vandetanib in First Line Treatment of Advanced Urothelial Cell Cancer in Patients Who Are Not Suitable to Receive Cisplatin
Study ID: NCT01191892
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as carboplatin and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vandetanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether giving carboplatin and gemcitabine hydrochloride is more effective with or without vandetanib as first-line therapy in treating urinary tract cancer. PURPOSE: This randomized phase II trial is studying giving carboplatin together with gemcitabine hydrochloride and to see how well it works when given with or without vandetanib as first-line therapy in treating patients with locally advanced or metastatic urinary tract cancer.
Detailed Description: OBJECTIVES: Primary * To determine the antitumor activity (as measured by progression-free survival) of carboplatin and gemcitabine hydrochloride with versus without vandetanib as first-line treatment in patients with locally advanced or metastatic urothelial cell cancer who are not suitable to receive cisplatin. Secondary * To determine the safety, feasibility, and tolerability of these regimens in these patients. * To determine the objective response rate. * To determine the overall survival of patients treated with these regimens * To assess the change of size of measurable lesions at 9 weeks of study therapy. OUTLINE: This is a multicenter study. Patients are stratified according to relevant factors. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive carboplatin IV over 30 minutes on day 1, gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and an oral placebo once daily on days 1-21. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. * Arm II: Patient receive carboplatin and gemcitabine hydrochloride as in arm I. Patients also receive oral vandetanib once daily on days 1-21. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Blood and urine samples may be collected for laboratory analysis at baseline and after completion of study. After completion of study treatment, patients are followed up at weeks 18, 26, 39, and 52. Peer Reviewed and Funded or Endorsed by Cancer Research UK.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Beatson West of Scotland Cancer Centre, Glasgow, Scotland, United Kingdom
Wales Cancer Trials Unit, Cardiff, Wales, United Kingdom
Ayr Hospital, Ayr, , United Kingdom
Royal Bournemouth General Hospital, Bournemouth, , United Kingdom
Queens Hospital, Burton upon Trent, , United Kingdom
Velindre Hospital, City And County Of Cardiff, , United Kingdom
Western General Hospital, Edinburgh, , United Kingdom
Calderdale Royal Infirmary, Halifax, , United Kingdom
Huddersfield Royal Infirmary, Huddersfield, , United Kingdom
The Royal Lancaster Infirmary, Lancaster, , United Kingdom
St. James's University Hospital, Leeds, , United Kingdom
The Royal Free Hospital, London, , United Kingdom
St Marys Hospital, London, , United Kingdom
Charing Cross Hospital, London, , United Kingdom
Christie Hospital, Manchester, , United Kingdom
Mount Vernon Hospital, Northwood Middlesex, , United Kingdom
Churchill Hospital, Oxford, , United Kingdom
Weston Park Hospital, Sheffield, , United Kingdom
Southampton General Hospital, Southampton, , United Kingdom
Royal Surrey County Hospital, Surrey, , United Kingdom
The Royal Marsden Hospital, Surrey, , United Kingdom
Name: Robert Jones, MD
Affiliation: University of Glasgow
Role: PRINCIPAL_INVESTIGATOR