A Phase 1 interventional study of paclitaxel and semaxanib in Head and Neck Cancer, sponsored by Case Comprehensive Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-06-10.
Sponsored by Case Comprehensive Cancer Center · Phase 1, Interventional, and Treatment
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.
OBJECTIVES:
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.
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.
This study's enrollment of 12 is below the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →Case Comprehensive Cancer Center is the lead sponsor of 484 studies on the registry; 59 are open to participants now.
Of its 74 completed or terminated interventional studies of FDA-regulated products, 45 (61%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Patients receive paclitaxel IV over one hour on day 1. Treatment continues weekly in the absence of disease progression or unacceptable toxicity.
Patients receive SU5416 IV over one hour on days 1 and 4. Treatment continues weekly in the absence of disease progression or unacceptable toxicity.
Also known as: SU5416
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.
This study is completed, as verified in Jun 2010. You cannot join it, but the record below documents what was studied.
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Case Comprehensive Cancer Center