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

NCT00006361 | Completed Phase 2

• 3 other identifiers: CDR0000068232MSKCC-00049NCI-79
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Carcinoma of Unknown Primary; Head and Neck Cancer; Non-melanomatous Skin Cancer

Keywords

squamous cell carcinoma of the skin; recurrent skin cancer; stage IV nasopharyngeal cancer; recurrent metastatic squamous neck cancer with occult primary; metastatic squamous neck cancer with occult primary squamous cell carcinoma; squamous cell carcinoma of unknown primary; 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

Interventions

semaxanib DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Related 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.

  RESULT

MeSH Terms

Conditions

Neoplasms, Unknown Primary; Head and Neck Neoplasms; Skin Neoplasms; Nasopharyngeal Neoplasms; Squamous Cell Carcinoma of Head and Neck

Interventions

Semaxinib

Condition Hierarchy (Ancestors)

Neoplasm Metastasis; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• David G. Pfister, MD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 4, 2000
• First Posted: May 30, 2003
• Study Start: December 1, 2000
• Primary Completion: January 1, 2003
• Last Updated: December 4, 2009

Record last verified: 2002-12

Locations

US (1)