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 : Completed
First Posted : August 31, 2010
Last Update Posted : May 16, 2019
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)|
|Actual Enrollment :||82 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|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||September 5, 2016|
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
|Principal Investigator:||Robert Jones, MD||University of Glasgow|