Clinical trial · Interventional
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
NCT00006361CI-TRIAL-00002846completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma of Unknown Primary | Carcinoma of Unknown Primary | ONTOLOGY_EXACT | 0.98 |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Non-melanomatous Skin Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| semaxanib | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTZahalsky 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.