Metastatic Transitional Cell Cancer of the Urothelial Tract Clinical Trial
Official title:
A Phase II, Single-arm Study of Docetaxel and Oxaliplatin in Metastatic Cisplatin-resistant Transitional Cell Carcinoma of the Urinary Bladder
The purpose of this non-randomized Phase II trial was to evaluate the efficacy of a combination of docetaxel and oxaliplatin in patients with metastatic transitional cell cancer (TCC) of the urothelial tract. The primary endpoint was to assess response, as defined as a 25% reduction in measurable disease per the RECIST criteria. Measurable or evaluable objective response rate, time to disease progression and survival were also assessed.
This non-randomized Phase II trial was to evaluate the efficacy of a combination of docetaxel
and oxaliplatin in patients with metastatic transitional cell cancer (TCC) of the urothelial
tract. The primary endpoint was to assess response, as defined as a 25% reduction in
measurable disease per the RECIST criteria. Measurable or evaluable objective response rate,
time to disease progression and survival were also assessed.
Treatment was administered on an outpatient basis. No other concurrent therapy for malignant
disease was administered. Patients received both docetaxel and oxaliplatin, IV on day 1 of
each cycle. Treatment will be repeated every 21 days for up to 6 courses in the absence of
disease progression, unacceptable toxicity, or treatment delay > 3 weeks.
All patients should receive antiemetics prior to treatment. An oral or IV 5-HT3 receptor
antagonist in combination with a benzodiazepene and Decadron was recommended. To mitigate
docetaxel associated hypersensitivity reactions, Decadron was administered at a dose of 8mg
bid, 1 day prior to, the day of, and the day after administration of docetaxel (total of 3
days)
Day 1 of each cycle:
Docetaxel was administered at a dose of 60mg/m2 IV infusion, followed by oxaliplatin at a
dose of 110mg/m2 as a 2 hour IV infusion. Oxaliplatin solution was further diluted in an
infusion solution of 250 mL to 500 mL Dextrose 5% in Water (D5W). Oxaliplatin was be capped
at a maximum BSA of 2.0
Day 2 of each cycle:
Patients received growth factor support as needed. At the discretion of the investigator,
patients were treated with both white and red cell growth factors. Generally, white cell
support is recommended if patients experience a febrile neutropenia with the preceeding
cycle, or are over the age of 70 yrs, and thought to be at a high risk of febrile neutropenia
(74-76)
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