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

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.

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.

Eligibility 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