Sunitinib Malate in Treating Patients With Locally Recurrent, Locally Advanced, Unresectable, or … (NCT01118039) | Clinical Trial Compass
UnknownPhase 2
Sunitinib Malate in Treating Patients With Locally Recurrent, Locally Advanced, Unresectable, or Metastatic Urinary Tract Cancer
Spain41 participantsStarted 2006-07
Plain-language summary
RATIONALE: Sunitinib malate 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.
PURPOSE: This phase II trial is studying the side effects of giving sunitinib malate and to see how well it works in treating patients with locally recurrent, locally advanced, unresectable, or metastatic urinary tract cancer.
Who can participate
Age range
18 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 or cytologically confirmed transitional cell carcinoma of the urinary tract meeting ≥ 1 of the following criteria:
* Unresectable, locally recurrent disease
* Locally recurrent disease must not be amenable to resection or radiotherapy with curative intent
* Locally advanced or metastatic disease
* No prior chemotherapy for advanced disease
* Ineligible (unfit) for cisplatin-based chemotherapy due to creatinine clearance \< 60 mL/min but \> 30 mL/min
* Measurable or nonmeasurable disease according to RECIST criteria
* Measurable lesions that have been previously irradiated will not be considered target lesions unless increase in size has been observed following completion of radiation therapy
PATIENT CHARACTERISTICS:
* See Disease Characteristics
* ECOG performance status 0-1
* Life expectancy \> 12 weeks
* Absolute neutrophil count ≥ 1,500/μL
* Platelet count ≥ 100,000/μL
* Hemoglobin ≥ 9.0 g/dL
* Total serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
* Serum creatinine ≤ 1.5 times ULN
* AST and ALT ≤ 2.5 times ULN (≤ 5 times ULN if liver function abnormalities are due to underlying malignancy)
* Serum albumin ≥ 3.0 g/dL
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during study therapy
* No diagnosis of a second malignancy within the past 3 years except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervi…
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.