Carboplatin and Gemcitabine Hydrochloride With or Without Vandetanib as First-Line Therapy in Treating Patients With Locally Advanced or Metastatic Urinary Tract Cancer
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|ClinicalTrials.gov Identifier: NCT01191892|
Recruitment Status : Unknown
Verified July 2012 by Wales Cancer Trials Unit.
Recruitment status was: Recruiting
First Posted : August 31, 2010
Last Update Posted : July 31, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter Ureter Cancer Urethral Cancer||Drug: carboplatin Drug: gemcitabine hydrochloride Drug: vandetanib Drug: Placebo||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||122 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 Start Date :||June 2010|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||December 2014|
Placebo Comparator: Placebo
Carboplatin, Gemcitabine and Placebo
Drug: gemcitabine hydrochloride
Placebo of vandetanib tablet
Carboplatin, Gemcitabine and vandetanib
Drug: gemcitabine hydrochloride
- Progression Free Survival [ Time Frame: 1 year ]Time to event PFS, follow-up to 1 year
- Tolerability and feasibility [ Time Frame: 1 year ]Rate of randomisation and safety profile of randomised patients
- Objective response rate as assessed by RECIST criteria [ Time Frame: Up to 1 year ]Proportion of patients responding to treatment
- Overall survival [ Time Frame: 2 years ]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 ]
- Toxicity during and after treatment as assessed by NCI CTCAE v 4.0 [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01191892
|Contact: Tracie Maddenemail@example.com|
|Beatson West of Scotland Cancer Centre||Recruiting|
|Glasgow, Scotland, United Kingdom, G12 0YN|
|Contact: Contact Person 44-141-301-7095 Rob.Jones@ggc.scot.nhs.uk|
|Wales Cancer Trials Unit||Recruiting|
|Cardiff, Wales, United Kingdom, CF11 9LJ|
|Contact: Contact Person 44-29-2019-6800|
|Ayr, United Kingdom, KA66DX|
|Contact: Margaret McKernan 01563 825749 firstname.lastname@example.org|
|Principal Investigator: Jawaher Ansari|
|Royal Bournemouth General Hospital||Recruiting|
|Bournemouth, United Kingdom, BH7 7DW|
|Contact: Susannah Brock email@example.com|
|Principal Investigator: Susannah Brock|
|Burton upon Trent, United Kingdom, DE13 0RB|
|Contact: Pugazhenthi Pattu 01332 340131 firstname.lastname@example.org|
|Principal Investigator: Pugazhenthi Pattu|
|City and County of Cardiff, United Kingdom, CF142TL|
|Contact: Dr Lester, Jason 44-2920 196159 email@example.com|
|Principal Investigator: Jason Lester|
|Western General Hospital||Recruiting|
|Edinburgh, United Kingdom, EH4 2XU|
|Contact: Duncan McLaren firstname.lastname@example.org|
|Principal Investigator: Duncan McLaren|
|Calderdale Royal Infirmary||Recruiting|
|Halifax, United Kingdom, HX30PW|
|Contact: Lisa Gledhill 01484 342925 email@example.com|
|Principal Investigator: Ursula Hofmann|
|Huddersfield Royal Infirmary||Recruiting|
|Huddersfield, United Kingdom, HD3 3EA|
|Contact: Uschi Hofmann 0484 847299 firstname.lastname@example.org|
|Principal Investigator: Uschi Hofmann|
|The Royal Lancaster Infirmary||Recruiting|
|Lancaster, United Kingdom, LA1 4RP|
|Contact: Alison Birtle 01524 583219 email@example.com|
|Principal Investigator: Alison Birtle|
|St. James's University Hospital||Recruiting|
|Leeds, United Kingdom, LS9 7TF|
|Contact: Satinder Jagdev 0113 2067645 firstname.lastname@example.org|
|Principal Investigator: Satinder Jagdev|
|The Royal Free Hospital||Not yet recruiting|
|London, United Kingdom, NW3 2QG|
|Principal Investigator: Maria Vilarino-Varela|
|St Marys Hospital||Not yet recruiting|
|London, United Kingdom, W21NY|
|Contact: Gillian Hornzee Gillian.Hornzee@imperial.nhs.uk|
|Principal Investigator: Simon Stewart|
|Charing Cross Hospital||Not yet recruiting|
|London, United Kingdom, W68RF|
|Contact: Simon Stewart email@example.com|
|Principal Investigator: Simon Stewart|
|Manchester, United Kingdom, M20 4BX|
|Contact: Tony Eliott 01619187214 firstname.lastname@example.org|
|Principal Investigator: Tony Eliott|
|Mount Vernon Hospital||Recruiting|
|Northwood Middlesex, United Kingdom, HA6 2RN|
|Contact: Peter Hoskin 01923 844533 email@example.com|
|Principal Investigator: Peter Hoskin|
|Oxford, United Kingdom, OX37LJ|
|Contact: Georgina Rogers firstname.lastname@example.org|
|Principal Investigator: Andrew Protheroe|
|Weston Park Hospital||Recruiting|
|Sheffield, United Kingdom, S102SJ|
|Contact: Linda Evans 0114 226500 email@example.com|
|Principal Investigator: Linda Evans|
|Southampton General Hospital||Recruiting|
|Southampton, United Kingdom, S016 6YD|
|Contact: Simon Crabb firstname.lastname@example.org|
|Principal Investigator: Simon Crabb|
|Royal Surrey County Hospital||Recruiting|
|Surrey, United Kingdom, GU27XX|
|Contact: Katie Wood 01483 571122 email@example.com|
|Principal Investigator: Katie Wood|
|The Royal Marsden Hospital||Recruiting|
|Surrey, United Kingdom, KT2 7QB|
|Contact: Robert Huddart 020 8661 3457 firstname.lastname@example.org|
|Principal Investigator: Robert Huddart|
|Principal Investigator:||Robert Jones, MD||University of Glasgow|