Expired Study
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New York, New York 10021


Purpose:

RATIONALE: SU5416 may stop the growth of cancer cells by stopping blood flow to the tumor. PURPOSE: Phase II trial to study the effectiveness of SU5416 in treating patients who have advanced or recurrent cancer of the head and neck.


Study summary:

OBJECTIVES: - Determine the effect of SU5416 on survival and tumor response in patients with advanced or recurrent squamous cell carcinoma of the head and neck. - Determine the safety and toxicity of SU5416 in these patients. OUTLINE: Patients receive SU5416 IV over 1 hour twice weekly. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed for 1 year. PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study within 1.4 years.


Criteria:

DISEASE CHARACTERISTICS: - Histologically proven epidermoid/squamous cell carcinoma of the oral cavity, lip, hypopharynx, oropharynx, nasopharynx, sinonasal tract, or larynx; undifferentiated carcinoma of the nasopharynx (WHO type III); sinonasal undifferentiated carcinoma; or squamous cell carcinoma of unknown primary or the skin with initial presentation in the head and neck region - Advanced or recurrent disease that is incurable with surgery or radiotherapy - No more than 2 prior cytotoxic chemotherapy regimens for recurrent, persistent, or metastatic disease - Prior exposure to chemopreventive agents (e.g., tretinoin or other vitamin analogues) is not considered to be a prior cytotoxic chemotherapy exposure - At least 1 measurable indicator lesion - Bone metastases, elevated enzyme levels, or lesions on radionuclide scans are not acceptable as the sole parameters of measurable disease - No history of brain metastases PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 60-100% Life expectancy: - Not specified Hematopoietic: - WBC greater than 3,000/mm3 - Hemoglobin greater than 8 g/dL - Platelet count greater than 100,000/mm3 - No history of coagulation disorder Hepatic: - Bilirubin normal - SGOT less than 2.5 times upper limit of normal - PT no greater than 14 seconds - aPTT no greater than 40 seconds Renal: - Creatinine less than 1.5 mg/dL OR - Creatinine clearance at least 60 mL/min Cardiovascular: - No uncompensated coronary artery disease - No myocardial infarction or severe/unstable angina within the past 6 months - No severe peripheral vascular disease associated with diabetes mellitus - No deep venous or arterial thrombosis within the past 3 months - No unstable cardiac rhythm - No cerebrovascular accident within the past 6 months Pulmonary: - No pulmonary embolism within the past 3 months Other: - No history of allergic reaction to paclitaxel - No other active malignancy except: - Basal cell or squamous cell skin cancer - Carcinoma in situ of the cervix - Synchronous epidermoid/squamous cell carcinoma of the head and neck (oral cavity, lip, hypopharynx, oropharynx, nasopharynx, sinonasal tract, or larynx) - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No active bacterial infection requiring antibiotics - No other concurrent medical condition that would increase risk PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - See Disease Characteristics Endocrine therapy: - Not specified Radiotherapy: - See Disease Characteristics - More than 4 weeks since prior radiotherapy Surgery: - See Disease Characteristics


NCT ID:

NCT00006361


Primary Contact:

Study Chair
David G. Pfister, MD
Memorial Sloan-Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 19, 2017

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