OGX-011 and Docetaxel in Treating Patients With Metastatic or Locally Recurrent Solid Tumors
Condition: Bladder Cancer; Breast Cancer; Kidney Cancer; Lung Cancer; Ovarian Cancer; Prostate Cancer; Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Breast Neoplasms; Lung Neoplasms; Prostatic Neoplasms; Urinary Bladder Neoplasms; Kidney Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: OGX-011 may kill tumor cells by blocking some of the proteins that may cause tumor
      cells to grow. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop
      the growth of tumor cells, either by killing the cells or by stopping them from dividing.
      Giving OGX-011 together with docetaxel may kill more tumor cells.

      PURPOSE: This phase I trial is studying the side effects and best dose of OGX-011 when given
      together with docetaxel in treating patients with metastatic or locally recurrent solid
      tumors.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the dose-limiting toxicity and recommended phase II dose of OGX-011 when
           administered with docetaxel in patients with metastatic or locally recurrent solid
           tumors.

      Secondary

        -  Determine the pharmacokinetic profile of this regimen in these patients.

        -  Assess the effect of OGX-011 on serum clusterin levels and clusterin expression in
           peripheral blood mononuclear cells and accessible tumors.

        -  Assess objective response in patients treated with this regimen.

      OUTLINE: This is an open-label, multicenter, dose-escalation study of OGX-011. Patients are
      sequentially assigned to 1 of 2 treatment schedules.

        -  Schedule A: Patients receive OGX-011 IV over 2 hours on days 1, 3, 5, 8, 15, 22, 29, and
           36 of course 1 and once weekly in weeks 1-6 of all subsequent courses. Patients also
           receive docetaxel IV over 1 hour once weekly in weeks 1-5. Treatment repeats every 6
           weeks for up to 4 courses in the absence of disease progression or unacceptable
           toxicity.

        -  Schedule B: Patients receive OGX-011 IV over 2 hours on days -7, -5, -3, 1, 8, and 15 of
           course 1 and days 1, 8, and 15 of all subsequent courses. Patients also receive
           docetaxel IV over 1 hour on day 1. Treatment repeats every 3 weeks (course 1 is 4 weeks
           in duration) for up to 4 courses in the absence of disease progression or unacceptable
           toxicity.

      Cohorts of 3-6 patients receive escalating doses of OGX-011 (in each schedule) until the
      recommended phase II dose (RPTD) is determined. The RPTD is defined as the dose preceding
      that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

      Patients undergo serum collection periodically for pharmacokinetic and pharmacodynamic
      analysis.

      After completion of study treatment, patients are followed at 4 weeks and then every 3 months
      thereafter.

      PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
    

Intervention name(s): custirsen sodium; docetaxel; pharmacological study
Intervention type(s): Drug; Drug; Other
Intervention MeSH terms: Docetaxel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent prostate cancer; stage IV prostate cancer; recurrent renal cell cancer; stage IV renal cell cancer; recurrent non-small cell lung cancer; stage IV non-small cell lung cancer; recurrent bladder cancer; stage IV bladder cancer; recurrent breast cancer; stage IV breast cancer; recurrent ovarian epithelial cancer; stage IV ovarian epithelial cancer; unspecified adult solid tumor, protocol specific; male breast cancer