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

A Phase II Trial of SU5416 (NSC #696819) in Patients With Advanced or Recurrent Squamous Cell Carcinoma 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.

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