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Study of Docetaxel and Oxaliplatin in Metastatic Transitional Cell Cancer (TCC) of the Urothelial Tract

NCT03159143 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2017-08-11

Study results available
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Summary

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.

Conditions

  • Metastatic Transitional Cell Cancer of the Urothelial Tract

Interventions

DRUG

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.

DRUG

Oxaliplatin

Alkylating antineoplastic agent. It is administered on day 1 of each cycle at a dose of 110 mg/m\^2

Sponsors & Collaborators

  • Sanofi-Synthelabo

    collaborator INDUSTRY

  • Leonard Appleman

    lead OTHER

Principal Investigators

  • Leonard Appleman, MD · Univesity of Pittsburgh

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-12-17
Primary Completion
2009-06-02
Completion
2009-12-02
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03159143 on ClinicalTrials.gov