Carboplatin and Gemcitabine Hydrochloride With or Without Vandetanib as First-Line Therapy in Treating Patients With Locally Advanced or Metastatic Urinary Tract Cancer

Phase 2

Completed

• Conditions: Bladder Cancer; Transitional Cell Cancer of the Renal Pelvis and Ureter; Ureter Cancer; Urethral Cancer
• Interventions: Drug: carboplatin; Drug: gemcitabine hydrochloride; Drug: Placebo; Drug: vandetanib

• Registration Number: NCT01191892
• Lead Sponsor: Cardiff University

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.

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-08-29
• Study First Submitted QC: 2010-08-29
• Study First Posted: 2010-08-31
• Primary Completion: 2015-12
• Study Completion: 2016-09-05
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-14
• Last Update Posted: 2019-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	gemcitabine hydrochloride	Carboplatin, Gemcitabine and Placebo
Placebo	Placebo	Carboplatin, Gemcitabine and Placebo
vandetanib	gemcitabine hydrochloride	Carboplatin, Gemcitabine and vandetanib
Placebo	carboplatin	Carboplatin, Gemcitabine and Placebo
vandetanib	carboplatin	Carboplatin, Gemcitabine and vandetanib
vandetanib	vandetanib	Carboplatin, Gemcitabine and vandetanib

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	1 year	Time to event PFS, follow-up to 1 year

Secondary Outcome Measures

Name	Time	Method
Tolerability and feasibility	1 year	Rate of randomisation and safety profile of randomised patients
Objective response rate as assessed by RECIST criteria	Up to 1 year	Proportion of patients responding to treatment
Overall survival	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	9 weeks
Toxicity during and after treatment as assessed by NCI CTCAE v 4.0	1 year

Trial Locations

Locations (21)

Beatson West of Scotland Cancer Centre; 🇬🇧 Glasgow, Scotland, United Kingdom

Royal Bournemouth General Hospital; 🇬🇧 Bournemouth, United Kingdom

Royal Surrey County Hospital; 🇬🇧 Surrey, United Kingdom

Velindre Hospital; 🇬🇧 City And County Of Cardiff, United Kingdom

Huddersfield Royal Infirmary; 🇬🇧 Huddersfield, United Kingdom

The Royal Lancaster Infirmary; 🇬🇧 Lancaster, United Kingdom

Ayr Hospital; 🇬🇧 Ayr, United Kingdom

Western General Hospital; 🇬🇧 Edinburgh, United Kingdom

Calderdale Royal Infirmary; 🇬🇧 Halifax, United Kingdom

The Royal Free Hospital; 🇬🇧 London, United Kingdom

Weston Park Hospital; 🇬🇧 Sheffield, United Kingdom

The Royal Marsden Hospital; 🇬🇧 Surrey, United Kingdom

Southampton General Hospital; 🇬🇧 Southampton, United Kingdom

St. James's University Hospital; 🇬🇧 Leeds, United Kingdom

Mount Vernon Hospital; 🇬🇧 Northwood Middlesex, United Kingdom

Churchill Hospital; 🇬🇧 Oxford, United Kingdom

Wales Cancer Trials Unit; 🇬🇧 Cardiff, Wales, United Kingdom

Queens Hospital; 🇬🇧 Burton upon Trent, United Kingdom

St Marys Hospital; 🇬🇧 London, United Kingdom

Christie Hospital; 🇬🇧 Manchester, United Kingdom

Charing Cross Hospital; 🇬🇧 London, United Kingdom