AEG35156 and Docetaxel in Treating Patients With Solid Tumors
Condition: Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: 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.
      AEG35156 may help docetaxel work better by making tumor cells more sensitive to the drug.

      PURPOSE: This phase I trial is studying the side effects and best dose of AEG35156 when given
      together with docetaxel in treating patients with solid tumors.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the maximum tolerated dose and define the recommended phase II dose of
           AEG35156 in combination with docetaxel in patients with solid tumors.

      Secondary

        -  Determine the qualitative and quantitative toxicities of AEG35156 and docetaxel and
           define duration and reversibility of those toxicities.

        -  Determine the pharmacokinetic profile of this regimen.

        -  Assess, preliminarily, the antitumor activity of this regimen in patients with
           measurable disease.

        -  Assess the pharmacodynamic effects of AEG35156 administration on X-linked inhibitor of
           apoptosis protein (XIAP) levels and apoptosis in peripheral blood mononuclear cells and,
           in selected patients, in tumor tissue.

        -  Evaluate M30/M65 cytokeratin 18 level, a marker of apoptosis/necrosis of epithelial
           tumors, in these patients.

      OUTLINE: This is a multicenter, open-label, dose-escalation study of AEG35156.

      Patients receive AEG35156 IV continuously on days -2 and -1. Patients then receive AEG35156
      IV continuously over 24 hours on days 1, 8, and 15. Beginning with course 2, patients also
      receive docetaxel IV over 1 hour on day 1. Treatment repeats every 3 weeks for up to 6
      courses in the absence of disease progression or unacceptable toxicity.

      Cohorts of 3-6 patients receive escalating doses of AEG35156 until the maximum tolerated dose
      (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6
      patients experience dose-limiting toxicity.

      Blood is collected at baseline and periodically during study treatment for pharmacokinetic
      and pharmacodynamic assessment.

      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): AEG35156; docetaxel
Intervention type(s): Drug; Drug
Intervention description(s): After a recommended phase II dose (RPTD) of AEG35156 has been determined with docetaxel 75 mg/m2, patients will be accrued to the RPTD-1 plus docetaxel 100 mg/m2, and possibly RPTD plus docetaxel 100 mg/m2, to determine the RPTD of AEG35156 in combination with docetaxel 100 mg/m2 given every three weeks.; After a recommended phase II dose (RPTD) of AEG35156 has been determined with docetaxel 75 mg/m2, patients will be accrued to the RPTD-1 plus docetaxel 100 mg/m2, and possibly RPTD plus docetaxel 100 mg/m2, to determine the RPTD of AEG35156 in combination with docetaxel 100 mg/m2 given every three weeks.
Intervention MeSH terms: Docetaxel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: unspecified adult solid tumor, protocol specific