Clinical trial NCT00006361: SU5416 in Treating Patients With Advanced or Recurrent Cancer of the Head and Neck
Official title: A Phase II Trial of SU5416 (NSC #696819) in Patients With Advanced or Recurrent Squamous Cell Carcinoma of the Head and Neck
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma of Unknown Primary
Head and Neck Cancer
Non-melanomatous Skin Cancer
Keywords: squamous cell carcinoma of the skin
recurrent skin cancer
stage IV nasopharyngeal cancer
recurrent metastatic squamous neck cancer with occult primary
metastatic squamous neck cancer with occult primary squamous cell carcinoma
squamous cell carcinoma of unknown primary
stage IV squamous cell carcinoma of the lip and oral cavity
recurrent squamous cell carcinoma of the lip and oral cavity
stage IV squamous cell carcinoma of the oropharynx
recurrent squamous cell carcinoma of the oropharynx
stage IV squamous cell carcinoma of the nasopharynx
recurrent squamous cell carcinoma of the nasopharynx
stage IV squamous cell carcinoma of the hypopharynx
recurrent squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the larynx
recurrent squamous cell carcinoma of the larynx
stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
recurrent carcinoma of unknown primary
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-05-30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: David G. Pfister, MD
role: STUDY_CHAIR
References:
citation: Zahalsky AJ, Wong RJ, Lis E, et al.: Phase II trial of SU5416 in patients with advanced incurable head and neck cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-902, 2002.