Bladder Cancer Clinical Trial
Official title:
A Phase I/II Single-Arm Trial to Evaluate the Combination of Cisplatin and Gemcitabine With the mTOR Inhibitor Temsirolimus for First-Line Treatment of Patients With Advanced Transitional Cell Carcinoma of the Urothelium
Verified date | February 2018 |
Source | Cardiff University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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. Temsirolimus may stop the growth of tumor cells by blocking some
of the enzymes needed for cell growth. Giving gemcitabine hydrochloride and cisplatin
together with temsirolimus may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of temsirolimus
given together with gemcitabine hydrochloride and cisplatin as first-line therapy in treating
patients with locally advanced and/or metastatic transitional cell cancer of the urothelium.
Status | Completed |
Enrollment | 15 |
Est. completion date | March 16, 2016 |
Est. primary completion date | January 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years to 120 Years |
Eligibility |
DISEASE CHARACTERISTICS: - Histologically confirmed transitional cell carcinoma of the urothelium - Pure or mixed histology - Upper or lower urinary tract - Radiologically evaluable* locally advanced and/or metastatic disease not amenable to curative treatment with surgery or radiotherapy, meeting any 1 of the following criteria: - T4b, any N, any M - Any T, N2-3, any M - Any T, any N, M1 - NOTE: *Patients enrolled in the phase II portion of the trial must have radiologically measurable disease. - No transitional cell 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 - PT or INR = 1.5 - GFR = 60 mL/min (uncorrected for surface area and measured by isotopic means) - 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 symptomatic coronary artery disease, myocardial infarction within the past 6 months, congestive cardiac failure (NYHA class III or IV disease), or uncontrolled or symptomatic cardiac arrhythmia - No clinically significant bacterial or fungal infection 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 which have known adverse interactions with the treatment used on this trial (e.g., CYP3A4 inhibitors or inducers in phase I of this trial) - No prior or concurrent live vaccines (e.g., measles, mumps, rubella, oral polio, Bacille Calmette-Guérin [BCG], yellow fever, varicella, and TY21a typhoid vaccines) - No concurrent grapefruit juice |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Leeds Cancer Centre at St. James's University Hospital | Leeds | England |
Lead Sponsor | Collaborator |
---|---|
Cardiff University |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety (recommended phase II dose and dose-limiting toxicities) (phase I) | |||
Primary | Progression-free survival at 6 months (phase I) | |||
Secondary | Pharmacokinetics (phase I) | |||
Secondary | Safety, including tolerability and feasibility (phase II) | |||
Secondary | Overall survival (phase II) | |||
Secondary | Progression-free survival (time-to-event) (phase II) | |||
Secondary | Objective (radiological) response rate according to RECIST criteria (phase II) | |||
Secondary | Toxicity during and after treatment according to NCI CTCAE v 3.0 (phase II) |
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