Study of Docetaxel and Oxaliplatin in Metastatic Transitional Cell Cancer (TCC) of the Urothelial Tract
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|ClinicalTrials.gov Identifier: NCT03159143|
Recruitment Status : Completed
First Posted : May 18, 2017
Results First Posted : August 11, 2017
Last Update Posted : August 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Transitional Cell Cancer of the Urothelial Tract||Drug: Docetaxel Drug: Oxaliplatin||Phase 2|
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)
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This is a non-randomized Phase II trial in metastatic transitional cell cancer (TCC) of the urothelial tract.|
|Masking:||None (Open Label)|
|Official Title:||A Phase II, Single-arm Study of Docetaxel and Oxaliplatin in Metastatic Cisplatin-resistant Transitional Cell Carcinoma of the Urinary Bladder|
|Actual Study Start Date :||December 17, 2004|
|Actual Primary Completion Date :||June 2, 2009|
|Actual Study Completion Date :||December 2, 2009|
Experimental: Docetaxel and Oxaliplatin
Docetaxel administered at a dose of 60mg/m^2 IV infusion, followed by oxaliplatin at a dose of 110mg/m^2 as a 2 hour IV infusion.
Docetaxel (28) is a semi-synthetic taxane which blocks mitosis by preventing microtubule depolymerization. It mediates its actions by binding to a different set of microtubule-associated proteins than paclitaxel. It is administered every 3 weeks as a 30 minute infusion at doses between 60 to 75 mg/m^2.
Other Name: Taxotere
Alkylating antineoplastic agent. It is administered on day 1 of each cycle at a dose of 110 mg/m^2
- Response Rate [ Time Frame: Up to 4 years ]Percentage of patients who experienced a greater than or equal to a 30% reduction in measurable disease, as per the RECIST criteria.
- Time to Progression (TTP) [ Time Frame: Up to 4 years ]Time to progression (TTP) will be calculated as number of months from the date of first treatment to the date of disease progression or the date of death (disease-related causes) or the cut-off date.
- Disease Control Rate (DCR) [ Time Frame: Up to 4 years ]Percentage of patients who achieved complete response, partial response and stable disease. DCR will be calculated from the first day of the first cycle to the date of metastatic or primary tumor relapse, or last contact date, or date of death (if death comes before disease progression), or data cut-off.
- Overall Survival [ Time Frame: Up to 4 years ]The overall survival will be calculated as the number of months from the date of first treatment until death or the cut-off date.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03159143
|United States, Pennsylvania|
|University of Pittsburgh Cancer Institute|
|Pittsburgh, Pennsylvania, United States, 15232|
|Principal Investigator:||Leonard Appleman, MD||Univesity of Pittsburgh|