Carboplatin and Gemcitabine Hydrochloride With or Without Vandetanib as First-Line Therapy in Tre… (NCT01191892) | Clinical Trial Compass
CompletedPhase 2
Carboplatin and Gemcitabine Hydrochloride With or Without Vandetanib as First-Line Therapy in Treating Patients With Locally Advanced or Metastatic Urinary Tract Cancer
United Kingdom82 participantsStarted 2010-06
Plain-language 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.
Who can participate
Age range
18 Years – 120 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Histologically confirmed transitional cell carcinoma (pure or mixed histology) of the urothelium (upper or lower urinary tract)
* Cancers with other pathologies are permitted provided the dominant morphology is transitional cell carcinoma
* Radiologically measurable disease according to RECIST v 1.1 criteria
* Locally advanced and/or metastatic disease not amenable to curative treatment with surgery or radiotherapy
* Patient not suitable for cisplatin therapy, meeting 1 or more of the following criteria:
* More than 75 years of age
* ECOG performance status \> 2
* Creatinine clearance \< 30 mL/min
* Clinically significant ischemic heart disease (myocardial infarction or unstable angina more than 3 but less than 12 months prior to date of randomization, symptomatic angina, or NYHA class I within 3 months prior to date of randomization)
* Prior intolerance of cisplatin
* Any other factor that, in the opinion of the investigator, indicates that cisplatin is not suitable for the patient (e.g., unilateral hearing loss)
PATIENT CHARACTERISTICS:
* See Disease Characteristics
* ECOG performance status 0-2
* Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
* Creatinine clearance ≥ 30 mL/min
* Potassium ≥ 4.0 mmol/L OR below the CTCAE grade 1 upper limit
* Magnesium normal OR below the CTCAE grade 1 upper limit
* Serum calcium ≤ 2.9 mmol/L (If serum calcium is \< lower limit of normal \[LLN\], then adjusted serum calcium must be ≥ LL…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.