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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.
Full description
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, phase I dose-escalation study of temsirolimus followed by a phase II study.
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, cisplatin IV over 3-4 hours on day 1, and temsirolimus IV over 30 minutes on days 1 or 2, 8 or 9, and 15. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Blood specimens may be collected periodically for pharmacokinetic studies.
After completion of study treatment, patients are followed at 6 months and 1 year.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
Enrollment
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Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Histologically confirmed transitional cell carcinoma of the urothelium
Radiologically evaluable* locally advanced and/or metastatic disease not amenable to curative treatment with surgery or radiotherapy, meeting any 1 of the following criteria:
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:
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
No concurrent anticoagulant therapy with warfarin or unfractionated 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
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Data sourced from clinicaltrials.gov
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