Carboplatin and Gemcitabine Hydrochloride With or Without Vandetanib as First-Line Therapy in Treating Patients With Locally Advanced or Metastatic Urinary Tract Cancer
Recruitment status was: Recruiting
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.
Transitional Cell Cancer of the Renal Pelvis and Ureter
Drug: gemcitabine hydrochloride
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
- Progression Free Survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]Time to event PFS, follow-up to 1 year
- Tolerability and feasibility [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]Rate of randomisation and safety profile of randomised patients
- Objective response rate as assessed by RECIST criteria [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]Proportion of patients responding to treatment
- Overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]Patients will be followed up until death by using NHS flagging service.
- Change in size of measurable lesions 9 weeks after start of chemotherapy [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
- Toxicity during and after treatment as assessed by NCI CTCAE v 4.0 [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2010|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
Carboplatin, Gemcitabine and Placebo
Drug: gemcitabine hydrochloride
Placebo of vandetanib tablet
Carboplatin, Gemcitabine and vandetanib
|Drug: carboplatin Drug: gemcitabine hydrochloride Drug: vandetanib|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01191892
|Beatson West of Scotland Cancer Centre|
|Glasgow, Scotland, United Kingdom, G12 0YN|
|Wales Cancer Trials Unit|
|Cardiff, Wales, United Kingdom, CF11 9LJ|
|Ayr, United Kingdom, KA66DX|
|Royal Bournemouth General Hospital|
|Bournemouth, United Kingdom, BH7 7DW|
|Burton upon Trent, United Kingdom, DE13 0RB|
|City and County of Cardiff, United Kingdom, CF142TL|
|Western General Hospital|
|Edinburgh, United Kingdom, EH4 2XU|
|Calderdale Royal Infirmary|
|Halifax, United Kingdom, HX30PW|
|Huddersfield Royal Infirmary|
|Huddersfield, United Kingdom, HD3 3EA|
|The Royal Lancaster Infirmary|
|Lancaster, United Kingdom, LA1 4RP|
|St. James's University Hospital|
|Leeds, United Kingdom, LS9 7TF|
|The Royal Free Hospital|
|London, United Kingdom, NW3 2QG|
|St Marys Hospital|
|London, United Kingdom, W21NY|
|Charing Cross Hospital|
|London, United Kingdom, W68RF|
|Manchester, United Kingdom, M20 4BX|
|Mount Vernon Hospital|
|Northwood Middlesex, United Kingdom, HA6 2RN|
|Oxford, United Kingdom, OX37LJ|
|Weston Park Hospital|
|Sheffield, United Kingdom, S102SJ|
|Southampton General Hospital|
|Southampton, United Kingdom, S016 6YD|
|Royal Surrey County Hospital|
|Surrey, United Kingdom, GU27XX|
|The Royal Marsden Hospital|
|Surrey, United Kingdom, KT2 7QB|
|Principal Investigator:||Robert Jones, MD||University of Glasgow|