Clinical trial NCT00005647: SU5416 and Paclitaxel in Treating Patients With Recurrent, Locally Advanced or Metastatic Cancer of the Head and Neck
Official title: A Phase I Pharmacokinetic, Pharmacodynamic, and Clinical Study of the Combination of the Angiogenesis Inhibitor SU5416 and Paclitaxel in Recurrent or Metastatic Carcinoma of the Head and Neck
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Head and Neck Cancer
Keywords: thyroid gland medullary carcinoma
anaplastic thyroid cancer
recurrent thyroid cancer
recurrent salivary gland cancer
recurrent metastatic squamous neck cancer with occult primary
stage III follicular thyroid cancer
metastatic squamous neck cancer with occult primary squamous cell carcinoma
recurrent hypopharyngeal cancer
stage III adenoid cystic carcinoma of the oral cavity
recurrent squamous cell carcinoma of the lip and oral cavity
recurrent verrucous carcinoma of the oral cavity
recurrent mucoepidermoid carcinoma of the oral cavity
recurrent adenoid cystic carcinoma of the oral cavity
recurrent squamous cell carcinoma of the oropharynx
recurrent lymphoepithelioma of the oropharynx
recurrent squamous cell carcinoma of the nasopharynx
recurrent lymphoepithelioma of the nasopharynx
recurrent squamous cell carcinoma of the hypopharynx
recurrent squamous cell carcinoma of the larynx
recurrent verrucous carcinoma of the larynx
recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
recurrent inverted papilloma of the paranasal sinus and nasal cavity
recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: OBJECTIVES:

* Determine the maximum tolerated dose and safety of SU5416 and paclitaxel in patients with recurrent or metastatic head and neck cancer.
* Determine the antiangiogenesis effect of this combination regimen in these patients.
* Determine the toxicity, pharmacodynamic effects, and pharmacokinetic parameters of this combination.

OUTLINE: This is a dose escalation study.

Patients receive paclitaxel IV over one hour on day 1 and SU5416 IV over one hour on days 1 and 4. Treatment continues weekly in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of paclitaxel and SU5416 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose limiting toxicities.

PROJECTED ACCRUAL: A total of 34 patients will be accrued for this study within 9-15 months.

Eligibility 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

Primary outcomes:
measure: Determine the maximum tolerated dose and safety of SU5416 and paclitaxel.
timeFrame: Treatment continues weekly in the absence of disease progression or unacceptable toxicity.
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
name: Scot C. Remick, MD
role: STUDY_CHAIR
References: