This trial is active, not recruiting.

Conditions bladder cancer, transitional cell cancer of the renal pelvis and ureter, urethral cancer
Treatments cisplatin, gemcitabine hydrochloride, sunitinib malate
Phase phase 2
Targets VEGF, FLT-3, KIT, PDGF
Sponsor Wales Cancer Trials Unit
Collaborator Cardiff University
Start date April 2009
End date July 2013
Trial size 63 participants
Trial identifier NCT01089088, CDR0000667764, CRUK-07/044, EU-21013, EUDRACT-2007-007591-42, ISRCTN54607216, WCTU-SPON-416-07, WCTU-SUCCINCT


RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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. Giving gemcitabine hydrochloride and cisplatin together with sunitinib malate may kill more tumor cells.

PURPOSE: This phase II trial is studying the side effects of giving gemcitabine hydrochloride and cisplatin together with sunitinib malate and to see how well it works as first-line therapy in treating patients with locally advanced and/or metastatic transitional cell carcinoma of the urothelium.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Progression-free survival
time frame: 6 months

Secondary Outcomes

Toxicity during and after treatment according to NCI CTCAE v 3.0
time frame: 1 Year
Tolerability (side effects) and feasibility of use (number of patients requiring dose delays or reduction and/or treatment withdrawal)
time frame: 1 year
Overall survival
time frame: 3 years
Progression-free survival (time-to-event)
time frame: 1 year
Objective (radiological) response rate according to RECIST
time frame: 1 year

Eligibility Criteria

Male or female participants at least 16 years old.

DISEASE CHARACTERISTICS: - Histologically confirmed transitional cell carcinoma of the urothelium - Pure or mixed histology - Upper or lower urinary tract - Radiologically measurable, locally advanced and/or metastatic disease not amenable to curative treatment with surgery or radiotherapy meeting 1 of the following criteria: - T4b (bladder) or T4 (renal pelvis/ureter), any N, any M - Any T, N2-3, any M - Any T, any N, M1 - No urothelial cancer for which subsequent radical treatment is being considered with a view to possibly cure the disease - No history of CNS metastases PATIENT CHARACTERISTICS: - WHO performance status 0-2 - Life expectancy > 3 months - Absolute neutrophil count ≥ 1.5 x 10^9/L - Platelet count ≥ 100 x 10^9/L - Bilirubin ≤ 1.5 times upper limit of normal (ULN) - ALT and ALP ≤ 2.5 times ULN - GFR ≥ 60 mL/min (uncorrected for surface area and measured by isotopic means) - PT or INR ≤ 1.5 times ULN - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Fit to receive cisplatin-containing combination chemotherapy - No previous malignancy other than nonmelanoma skin cancer, carcinoma in situ of the cervix, or incidental localized prostate cancer - No known HIV positivity or chronic hepatitis B or C infection - No uncontrolled hypertension - No symptomatic coronary artery disease, myocardial infarction within the past 6 months, congestive cardiac failure (NYHA class III-IV disease), or uncontrolled or symptomatic cardiac arrhythmia - No clinically significant bacterial or fungal infection - No concurrent grapefruit juice PRIOR CONCURRENT THERAPY: - At least 1 month since prior radiotherapy or radiotherapy involving more than 30% of total bone marrow volume - At least 1 month since prior investigational drug - No prior systemic therapy for locally advanced or metastatic disease - Patients who have received prior neoadjuvant or adjuvant chemotherapy for urothelial cancer (up to 4 courses), completed at least 6 months prior to first documented disease progression, are eligible - No concurrent anticoagulant therapy with warfarin or unfractionated heparin - Patients requiring anticoagulation may be entered on study after successful conversion to low molecular weight heparin - No concurrent medications that have known adverse interactions with sunitinib malate (i.e., strong CYP3A4 inhibitors or inducers) - No prior or concurrent live vaccines (e.g., measles, mumps, rubella, oral polio, bacille Calmette-Guérin [BCG], yellow fever, varicella, and TY21a typhoid vaccines)

Additional Information

Official title A Phase II Single-Arm Trial to Evaluate Cisplatin and Gemcitabine Chemotherapy in Combination With Sunitinib for First-Line Treatment of Patients With Advanced Transitional Carcinoma of the Urothelium
Principal investigator Tom Geldart
Description OBJECTIVES: - To determine the activity, safety, and feasibility of gemcitabine hydrochloride and cisplatin in combination with sunitinib malate as first-line therapy in patients with locally advanced and/or metastatic transitional carcinoma of the urothelium. OUTLINE: This is a multicenter study. Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, cisplatin IV over 3-4 hours on day 1, and oral sunitinib malate once daily on days 2-15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 6 months and 1 year. Peer Reviewed and Funded or Endorsed by Cancer Research UK
Trial information was received from ClinicalTrials.gov and was last updated in February 2013.
Information provided to ClinicalTrials.gov by Wales Cancer Trials Unit.