Study of Docetaxel and Oxaliplatin in Metastatic Transitional Cell Cancer (TCC) of the Urothelial Tract
Condition: Metastatic Transitional Cell Cancer of the Urothelial Tract
Intervention: Docetaxel; Oxaliplatin
Intervention description: 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.; Alkylating antineoplastic agent. It is administered on day 1 of each cycle at a dose of 110 mg/m^2
Intervention MeSH terms: Docetaxel; Oxaliplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
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)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically or cytologically confirmed transitional cell
             carcinoma of the Urothelial tract.

          -  Confirmed metastatic disease.

          -  Measurable progressive disease is required.

          -  18 years of age. Because no dosing or adverse event data are currently available on
             the use of oxaliplatin in patients < 18 years of age, they are excluded from this
             study.

          -  Life expectancy of greater than 6 months.

          -  ECOG Performance status of 0-1.

          -  Must have received prior treatment with standard of care chemotherapy No more than 2
             prior regimens of cytotoxic chemotherapy.

          -  No other experimental treatment, cytotoxics or radiation 4 weeks prior to enrollment.

          -  Patients must have acceptable organ function as defined below:

        Hematopoietic: WBC > 2500/mm3 or ANC > 1500/mm3, hemoglobin > 9.0 g/dL, platelet count >
        100,000/mm3 Hepatic: Bilirubin < 1.5 mg/dL, SGOT/SGPT < 2 x ULN (< 4 x ULN if liver
        metastases present) Renal: Creatinine < 1.8 mg/dL

          -  Adequate neurologic function defined as no clinically significant peripheral
             neuropathy, defined as any neuropathy ≤ grade 1.

          -  Adequate cardiovascular function defined as no active congestive heart failure, no
             uncontrolled angina, no myocardial infarction within the past 6 months.

        Exclusion Criteria:

          -  Patients with known brain metastases should be excluded from this clinical trial
             because of their poor prognosis and because they often develop progressive neurologic
             dysfunction that would confound the evaluation of neurologic and other adverse events.

          -  No prior therapy with oxaliplatin is allowed.

          -  No history of allergic reactions attributed to the drugs used in this study or
             compounds of similar chemical or biologic composition.

          -  No history of intolerance or allergy to the antiemetics to be administered in
             conjunction with the study drugs (i.e., 5 HT3 antagonists).

          -  No concurrent other active cancer from another primary site, except squamous cell and
             basal cell carcinoma of the skin.

          -  No other serious concomitant illness will be allowed, including interstitial
             pneumonia, extensive and symptomatic fibrosis of the lung, uncontrolled hypertension,
             unstable angina, symptomatic congestive heart failure, NYHA Class III or IV, serious
             cardiac arrhythmia, uncontrolled diabetes mellitus or active infection.