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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
Sponsor:
Collaborator:
Sanofi-Synthelabo
Information provided by (Responsible Party):
Leonard Appleman, University of Pittsburgh

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Metastatic Transitional Cell Cancer of the Urothelial Tract
Interventions: Drug: Docetaxel
Drug: Oxaliplatin

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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: 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.

Oxaliplatin: Alkylating antineoplastic agent. It is administered on day 1 of each cycle at a dose of 110 mg/m2


Participant Flow:   Overall Study
    Docetaxel and Oxaliplatin
STARTED   22 
COMPLETED   22 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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: 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.

Oxaliplatin: Alkylating antineoplastic agent. It is administered on day 1 of each cycle at a dose of 110 mg/m2


Baseline Measures
   Docetaxel and Oxaliplatin 
Overall Participants Analyzed 
[Units: Participants]
 22 
Age 
[Units: Years]
Median (Full Range)
 66.4 
 (39.9 to 83.2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      9  40.9% 
Male      13  59.1% 


  Outcome Measures

1.  Primary:   Response Rate   [ Time Frame: Up to 4 years ]

2.  Secondary:   Time to Progression (TTP)   [ Time Frame: Up to 4 years ]

3.  Secondary:   Disease Control Rate (DCR)   [ Time Frame: Up to 4 years ]

4.  Secondary:   Overall Survival   [ Time Frame: Up to 4 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Leonard Appleman, MD
Organization: University of Pittsburgh
phone: 412-648-6538
e-mail: applemanlj@upmc.edu



Responsible Party: Leonard Appleman, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03159143     History of Changes
Other Study ID Numbers: UPCI 04-055
First Submitted: May 8, 2017
First Posted: May 18, 2017
Results First Submitted: July 12, 2017
Results First Posted: August 11, 2017
Last Update Posted: August 11, 2017