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.

Condition	Treatment or Intervention	Phase
lip and oral cavity cancer Skin Cancer Head and Neck Cancer Oropharyngeal Cancer	Procedure: biological response modifier therapy  Procedure: growth factor antagonist therapy  Procedure: anti-cytokine therapy  Procedure: antiangiogenesis therapy  Drug: SU5416	Phase II

Further Study Details: 

OBJECTIVES: I. Determine the effect of SU5416 on survival and tumor response in patients with advanced or recurrent squamous cell carcinoma of the head and neck. II. Determine the safety and toxicity of SU5416 in these patients.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY 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

--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

--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, or 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

New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States

Study chairs or principal investigators

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

Study ID Numbers:  CDR0000068232; MSKCC-00049; NCI-79
Record last reviewed:  May 2003
Last Updated:  October 13, 2004
Record first received:  October 4, 2000
ClinicalTrials.gov Identifier:  NCT00006361
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08