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SU5416 in Treating Patients With Advanced or Recurrent Cancer of the Head and Neck

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00006361
First received: October 4, 2000
Last updated: December 3, 2009
Last verified: December 2002

October 4, 2000
December 3, 2009
December 2000
January 2003   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00006361 on ClinicalTrials.gov Archive Site
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SU5416 in Treating Patients With Advanced or Recurrent Cancer of the Head and Neck
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.

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.

Interventional
Phase 2
Primary Purpose: Treatment
  • Carcinoma of Unknown Primary
  • Head and Neck Cancer
  • Non-melanomatous Skin Cancer
Drug: semaxanib
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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Not Provided
January 2003   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00006361
CDR0000068232, MSKCC-00049, NCI-79
Not Provided
Not Provided
Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: David G. Pfister, MD Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
December 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP