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

Head and Neck Cancer Clinical Trial

Official title:

A Phase II Trial of SU5416 (NSC #696819) in Patients With Advanced or Recurrent Squamous Cell Carcinoma of the Head and Neck

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006361
• Other study ID #: CDR0000068232
• Secondary ID: MSKCC-00049NCI-7
• Status: Completed
• Phase: Phase 2
• First received: October 4, 2000
• Last updated: December 3, 2009
• Start date: December 2000

Study information

• Verified date: December 2002
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: January 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma of Unknown Primary
• Carcinoma, Squamous Cell
• Head and Neck Cancer
• Head and Neck Neoplasms
• Neoplasms, Unknown Primary
• Non-melanomatous Skin Cancer
• Skin Neoplasms

Intervention

Drug:
• semaxanib

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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.