SU5416 and Paclitaxel in Treating Patients With Recurrent, Locally Advanced or Metastatic Cancer of the Head and Neck

• Status: Completed
• Trial end date: 2003-10-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: SU5416 may stop the growth of head and neck cancer by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining SU5416 with chemotherapy may kill more cancer cells.

PURPOSE: Phase I trial to study the effectiveness of SU5416 and paclitaxel in treating patients who have recurrent, locally advanced, or metastatic cancer of the head and neck.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Case Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Angiogenesis Inhibitors; Paclitaxel; Semaxinib

Criteria

DISEASE CHARACTERISTICS:

• Metastatic or loco-regionally recurrent malignancy of the head and neck (including salivary gland and thyroid) that is incurable by surgery or radiotherapy

• At least two distinct tumor masses OR

• One tumor mass at least 3 cm in diameter

• No brain metastases

• No pulmonary metastases as only site of disease

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• At least 12 weeks

Hematopoietic:

• WBC at least 3,500/mm3

• Granulocyte count at least 1,500/mm3

• Platelet count at least 100,000/mm3

• Hemoglobin greater than 9.0 g/dL

Hepatic:

• PT and PTT normal OR

• INR ratio less than 1.1

• Bilirubin less than 1.5 mg/dL

• AST and ALT less than 2 times upper limit of normal

Renal:

• Creatinine less than 1.5 mg/dL

• Creatinine clearance greater than 60 mL/min

Cardiovascular:

• No New York Heart Association class III or IV heart disease

• No uncompensated coronary artery disease

• No history of myocardial infarction or severe or unstable angina within the past 6 months

• No severe peripheral vascular disease

• No deep venous thrombosis or arterial thrombosis within the past 6 months

• No known hypercoagulable syndrome with predisposition to venous or arterial clots

Pulmonary:

• No pulmonary embolism within the past 6 months

Other:

• No prior cerebral hemorrhage

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• At least 3 weeks since palliative chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered

• At least 4 weeks since combined chemoradiotherapy and recovered

• Must be recovered from prior taxanes

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics

• At least 4 weeks since prior large field radiotherapy and recovered

Surgery:

• Not specified