Sunitinib in advanced urothelial cancer in combination with standard cisplatin/gemcitabine chemotherapy treatment
- Conditions
- ocally advanced and/or metastatic transitional cell carcinoma of the urotheliumCancerMalignant neoplasm of genital organs
- Registration Number
- ISRCTN54607216
- Lead Sponsor
- Cardiff University (UK)
- Brief Summary
2015 Results article in http://www.ncbi.nlm.nih.gov/pubmed/25465968 results
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 63
1. Aged greater than or equal to 18 years, either sex
2. Histologically confirmed transitional cell carcinoma (pure or mixed histology) of urothelium (upper or lower urinary tract)
3. Radiologically measurable locally advanced and/or metastatic disease (T4b Nany Many, Tany N2-3 Many or Tany Nany M1) not amenable to curative treatment with surgery or radiotherapy
4. Estimated life expectancy greater than three months
5. World Health Organization (WHO) performance status 0 - 2
6. Fit to receive cisplatin-containing combination chemotherapy
7. No prior systemic therapy for locally advanced or metastatic disease - patients who have received prior neoadjuvant or adjuvant chemotherapy for urothelial cancer (up to four cycles), completed at least six months prior to first documented disease progression will remain eligible
8. No prior radiotherapy within one month prior to registration or involving more than 30% of total bone marrow volume
9. No investigational drug within one month prior to registration
10. Adequate renal function (glomerular filtration rate [GFR] greater than 60 ml/min, uncorrected for surface area and measured by isotopic means
11. Adequate bone marrow function (absolute neutrophil count greater than or equal to 1.5 x 10^9/l; platelets greater than or equal to 100 x 10^9/l at baseline)
12. Adequate liver function (bilirubin less than or equal to 1.5 x upper limit of normal [ULN]; alanine aminotransferase [ALT] and alkaline phosphatase [ALP] less than or equal to 2.5 ULN at baseline)
13. Prothrombin time (PT) or International normalised ratio (INR) less than or equal to 1.5 x ULN
14. Written informed consent
1. Patients with transitional cell cancer in whom subsequent radical treatment is being considered with a view to possible cure
2. Previous malignancy other than non-melanoma skin cancer, cervical carcinoma in situ or incidental localised prostate cancer
3. Previously-identified central nervous system (CNS) metastases - routine baseline computed tomography (CT) scanning of the head is not a requirement for trial entry and should only be performed if clinically indicated
4. Women who are pregnant or breast feeding. Woman of childbearing potential must have a negative pregnancy test performed within seven days prior to the start of trial therapy.
5. Men and women not prepared to practice method(s) of birth control of established efficacy
6. Known infection with human immunodeficiency virus (HIV) or chronic hepatitis B or C
7. Uncontrolled hypertension
8. Symptomatic coronary artery disease, myocardial infarction within the last six months, congestive cardiac failure greater than New York Heart Association [NYHA] class II, uncontrolled or symptomatic cardiac arrhythmia
9. Clinically significant bacterial or fungal infection
10. Concurrent anticoagulant therapy with warfarin or un-fractionated heparin - patients requiring anti-coagulation may be entered after successful conversion to low molecular weight heparin (LMWH)
11. Concomitant medication which have adverse interactions with sunitinib
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Activity assessed as progression-free survival at 6 months
- Secondary Outcome Measures
Name Time Method