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Sponsors and Collaborators: |
Ireland Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005647 |
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 |
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Head and Neck Cancer |
Drug: paclitaxel Drug: semaxanib |
Phase I |
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 |
Study Start Date: | May 2000 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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 |
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 |
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 |
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 |