Expired Study
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New York, New York 10021


Purpose:

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 summary:

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.


Criteria:

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 is Available At:


Original ID:

CDR0000068232


NCT ID:

NCT00006361


Secondary ID:

MSKCC-00049


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Cancer Institute (NCI)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Primary Purpose: Treatment


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:


Overall Contact Information

Official Name:David G. Pfister, MD
Study Chair
Memorial Sloan-Kettering Cancer Center

Study Dates

Start Date:December 2000
Primary Completion Date:January 2003
Primary Completion Type:Actual
Verification Date:December 2002
Last Changed Date:December 3, 2009
First Received Date:October 4, 2000

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:semaxanib

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Memorial Sloan-Kettering Cancer Center
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation: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.

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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