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SU5416 and Paclitaxel in Treating Patients With Recurrent, Locally Advanced or Metastatic Cancer of the Head and Neck
This study has been completed.
First Received: May 2, 2000   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: Ireland Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005647
  Purpose

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.


Condition Intervention Phase
Head and Neck Cancer
Drug: paclitaxel
Drug: semaxanib
Phase I

MedlinePlus related topics: Cancer Head and Neck Cancer Tonsils and Adenoids
Drug Information available for: Paclitaxel Semaxanib SU 5416
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Phase IB 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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: May 2000
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005647

Locations
United States, Ohio
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5065
Sponsors and Collaborators
Ireland Cancer Center
Investigators
Study Chair: Scot C. Remick, MD Case Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000067834, CWRU-1399, NCI-T99-0084
Study First Received: May 2, 2000
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00005647     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Laryngeal Carcinoma
Thyroid Cancer, Medullary
Squamous Cell Carcinoma
Hypopharyngeal Cancer
Carcinoma, Adenoid Cystic
Thyroid Cancer, Follicular
Neoplasm Metastasis
Thyroid Cancer, Anaplastic
Papilloma
Salivary Gland Diseases
Adenocarcinoma, Follicular
Carcinoma, Medullary
Nasopharyngeal Carcinoma
Thyroid Neoplasms
Antimitotic Agents
Angiogenesis Inhibitors
Recurrence
SU 5416
Carcinoma
Metastatic Squamous Neck Cancer With Occult Primary
Paclitaxel
Head and Neck Neoplasms
Epidermoid Carcinoma
Tubulin Modulators
Adenoid Cystic Carcinoma
Carcinoma, Squamous Cell
Antineoplastic Agents, Phytogenic

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Paclitaxel
Therapeutic Uses
Head and Neck Neoplasms
Mitosis Modulators
Tubulin Modulators
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009