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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase

Completed

Phase 2

Conditions

Carcinoma of Unknown Primary

Head and Neck Cancer

Non-melanomatous Skin Cancer

Treatments

Drug: semaxanib

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00006361

CDR0000068232

MSKCC-00049

NCI-79

Details and patient eligibility

About

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.

Full description

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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