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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the maximum tolerated dose and safety of SU5416 and paclitaxel.

Outcome Time Frame:

Treatment continues weekly in the absence of disease progression or unacceptable toxicity.

Safety Issue:

Yes

Principal Investigator

Scot C. Remick, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CWRU1399

NCT ID:

NCT00005647

Start Date:

May 2000

Completion Date:

October 2003

Related Keywords:

  • Head and Neck Cancer
  • 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
  • Head and Neck Neoplasms

Name

Location

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065