SU5416 in Treating Patients With Advanced or Recurrent Cancer of the Head and Neck
December 3, 2009 updated by: Memorial Sloan Kettering Cancer Center
A Phase II Trial of SU5416 (NSC #696819) in Patients With Advanced or Recurrent Squamous Cell Carcinoma of the Head and Neck
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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New York, New York, United States, 10021
- Memorial Sloan-Kettering Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2000
Primary Completion (Actual)
January 1, 2003
Study Registration Dates
First Submitted
October 4, 2000
First Submitted That Met QC Criteria
May 29, 2003
First Posted (Estimate)
May 30, 2003
Study Record Updates
Last Update Posted (Estimate)
December 4, 2009
Last Update Submitted That Met QC Criteria
December 3, 2009
Last Verified
December 1, 2002
More Information
Terms related to this study
Keywords
- recurrent metastatic squamous neck cancer with occult primary
- metastatic squamous neck cancer with occult primary squamous cell carcinoma
- 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
- stage IV nasopharyngeal cancer
- squamous cell carcinoma of the skin
- recurrent skin cancer
- squamous cell carcinoma of unknown primary
Additional Relevant MeSH Terms
- Pathologic Processes
- Skin Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Neoplastic Processes
- Neoplasm Metastasis
- Head and Neck Neoplasms
- Carcinoma
- Skin Neoplasms
- Neoplasms, Unknown Primary
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Protein Kinase Inhibitors
- Semaxinib
Other Study ID Numbers
- CDR0000068232
- MSKCC-00049
- NCI-79
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