Head and Neck Cancer Clinical Trial
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
Verified date | June 2010 |
Source | Case Comprehensive Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 12 |
Est. completion date | October 2003 |
Est. primary completion date | December 2002 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
DISEASE CHARACTERISTICS: - Metastatic or loco-regionally recurrent malignancy of the head and neck (including salivary gland and thyroid) that is incurable by surgery or radiotherapy - At least two distinct tumor masses OR - One tumor mass at least 3 cm in diameter - No brain metastases - No pulmonary metastases as only site of disease PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - At least 12 weeks Hematopoietic: - WBC at least 3,500/mm3 - Granulocyte count at least 1,500/mm3 - Platelet count at least 100,000/mm3 - Hemoglobin greater than 9.0 g/dL Hepatic: - PT and PTT normal OR - INR ratio less than 1.1 - Bilirubin less than 1.5 mg/dL - AST and ALT less than 2 times upper limit of normal Renal: - Creatinine less than 1.5 mg/dL - Creatinine clearance greater than 60 mL/min Cardiovascular: - No New York Heart Association class III or IV heart disease - No uncompensated coronary artery disease - No history of myocardial infarction or severe or unstable angina within the past 6 months - No severe peripheral vascular disease - No deep venous thrombosis or arterial thrombosis within the past 6 months - No known hypercoagulable syndrome with predisposition to venous or arterial clots Pulmonary: - No pulmonary embolism within the past 6 months Other: - No prior cerebral hemorrhage - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - At least 3 weeks since palliative chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered - At least 4 weeks since combined chemoradiotherapy and recovered - Must be recovered from prior taxanes Endocrine therapy: - Not specified Radiotherapy: - See Disease Characteristics - At least 4 weeks since prior large field radiotherapy and recovered Surgery: - Not specified |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
Case Comprehensive Cancer Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determine the maximum tolerated dose and safety of SU5416 and paclitaxel. | Treatment continues weekly in the absence of disease progression or unacceptable toxicity. | Yes |
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