SU5416 in Treating Patients With Advanced or Recurrent Cancer of the Head and Neck

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase II Trial of SU5416 (NSC #696819) in Patients With Advanced or Recurrent Squamous Cell Carcinoma of the Head and Neck

Conditions
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Carcinoma of Unknown Primary, Head and Neck Cancer, Non-melanomatous Skin Cancer

Intervention / Treatment
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* Drug: semaxanib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: semaxanib|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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squamous cell carcinoma of the skin, recurrent skin cancer, stage IV nasopharyngeal cancer, recurrent metastatic squamous neck cancer with occult primary, metastatic squamous neck cancer with occult primary squamous cell carcinoma, squamous cell carcinoma of unknown primary, stage IV squamous cell carcinoma of the lip and oral cavity, recurrent squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the oropharynx, recurrent squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the nasopharynx, recurrent squamous cell carcinoma of the nasopharynx, stage IV squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the larynx, recurrent squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity, recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity, recurrent carcinoma of unknown primary