A Phase I Pharmacokinetic, Pharmacodynamic, and Clinical Study of the Combination of the Angiogenesis Inhibitor SU5416 and Paclitaxel in Recurrent or Metastatic Carcinoma of the Head and Neck
- Determine the maximum tolerated dose and safety of SU5416 and paclitaxel in patients
with recurrent or metastatic head and neck cancer.
- Determine the antiangiogenesis effect of this combination regimen in these patients.
- Determine the toxicity, pharmacodynamic effects, and pharmacokinetic parameters of this
OUTLINE: This is a dose escalation study.
Patients receive paclitaxel IV over one hour on day 1 and SU5416 IV over one hour on days 1
and 4. Treatment continues weekly in the absence of disease progression or unacceptable
Cohorts of 3-6 patients receive escalating doses of paclitaxel and SU5416 until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2
of 3 or 6 patients experience dose limiting toxicities.
PROJECTED ACCRUAL: A total of 34 patients will be accrued for this study within 9-15 months.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the maximum tolerated dose and safety of SU5416 and paclitaxel.
Treatment continues weekly in the absence of disease progression or unacceptable toxicity.
Scot C. Remick, MD
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
United States: Federal Government
|Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|