SU5416 and Paclitaxel in Treating Patients With Recurrent, Locally Advanced or Metastatic Cancer of the Head and Neck
RATIONALE: SU5416 may stop the growth of head and neck cancer by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining SU5416 with chemotherapy may kill more cancer cells.
PURPOSE: Phase I trial to study the effectiveness of SU5416 and paclitaxel in treating patients who have recurrent, locally advanced, or metastatic cancer of the head and neck.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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. [ Time Frame: Treatment continues weekly in the absence of disease progression or unacceptable toxicity. ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2000|
|Study Completion Date:||October 2003|
|Primary Completion Date:||December 2002 (Final data collection date for primary outcome measure)|
- 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 combination.
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 toxicity.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005647
|United States, Ohio|
|Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|Study Chair:||Scot C. Remick, MD||Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center|