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
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Progression Free Survival
Time to event PFS, follow-up to 1 year
1 year
No
Robert Jones, MD
Principal Investigator
University of Glasgow
United Kingdom: Medicines and Healthcare Products Regulatory Agency
CDR0000684016
NCT01191892
June 2010
December 2014
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