Full Text View
Tabular View
No Study Results Posted
Related Studies
SU5416 in Treating Patients With Advanced or Recurrent Cancer of the Head and Neck
This study is ongoing, but not recruiting participants.
Study NCT00006361   Information provided by National Cancer Institute (NCI)
First Received: October 4, 2000   Last Updated: July 23, 2008   History of Changes

October 4, 2000
July 23, 2008
December 2000
 
 
 
Complete list of historical versions of study NCT00006361 on ClinicalTrials.gov Archive Site
 
 
 
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.

Phase II
Interventional
Treatment
  • Carcinoma of Unknown Primary
  • Head and Neck Cancer
  • Non-Melanomatous Skin Cancer
Drug: semaxanib
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

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
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