Ixabepilone and Sunitinib Malate in Treating Patients With Progressive Advanced 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 ixabepilone, work in different ways to stop
      the growth of tumor cells, either by killing the cells or by stopping them from dividing.
      Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed
      for cell growth and by blocking blood flow to the tumor.

      PURPOSE: This phase I trial is studying the side effects and best dose of ixabepilone when
      given together with sunitinib malate in treating patients with progressive advanced solid
      tumors.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To determine the safety and toxicity profile of ixabepilone in combination with
           sunitinib malate in patients with progressive, advanced non-hematologic malignancies.

        -  To determine the recommended phase II dose of ixabepilone given weekly versus once every
           three weeks in combination with a fixed dose of sunitinib malate in these patients.

      Secondary

        -  To evaluate the pharmacokinetic profiles of the combination of ixabepilone and sunitinib
           malate and correlate them with activity and/or toxicity.

        -  To obtain preliminary efficacy data (complete response, partial response, or stable
           disease) of these treatment combinations.

        -  To correlate changes in angiogenesis biomarkers with clinical (safety and efficacy) and
           pharmacokinetic parameters in patients treated with these drug combinations.

        -  To estimate the optimal biological dose.

      OUTLINE: This is a dose escalation study of ixabepilone. Patients are assigned to 1 of 2
      treatment groups.

        -  Schedule A: Patients receive ixabepilone IV on days 1, 8, and 15. Beginning on day 8 of
           course 1, patients also receive oral sunitinib malate once daily. Courses repeat every
           28 days in the absence of disease progression or unacceptable toxicity.

        -  Schedule B: Patients receive ixabepilone IV on day 1. Beginning on day 8 of course 1,
           patients also receive oral sunitinib malate once daily. Courses repeat every 21 days in
           the absence of disease progression or unacceptable toxicity.

      Blood samples are collected periodically for biomarker and pharmacokinetic studies by flow
      cytometry.

      After completion of study therapy, patients are followed at 30 days and every 3 months for 1
      year.
    

Intervention name(s): Ixabepilone; Sunitinib
Intervention type(s): Drug; Drug
Intervention description(s): Administered intravenously. Dosage assigned by Phase I center as determined by dose-escalation schedule:
Schedule A: Weekly for 3 weeks each cycle (Days 1, 8 and 15)
Schedule B: Day 1 of each 3-week cycle.; For both Schedules A and B, daily, orally, starting on Day 8 of Cycle 1
Other intervention name(s): BMS-247550; Ixempra; Azaepothilone B; epothilone B lactam; Epothilone-B BMS 247550; Sunitinib Malate; Sutent; Butanedioic acid
Intervention MeSH terms: Sunitinib; Epothilone B; Epothilones
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: unspecified adult solid tumor, protocol specific