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

Sponsoren

Hauptsponsor: Memorial Sloan Kettering Cancer Center

Mitarbeiter: National Cancer Institute (NCI)

Quelle National Cancer Institute (NCI)
Kurze Zusammenfassung

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.

detaillierte Beschreibung

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.

Gesamtstatus Completed
Anfangsdatum December 2000
Primäres Abschlussdatum January 2003
Phase Phase 2
Studientyp Interventional
Bedingung
Intervention

Interventionsart: Drug

Interventionsname: semaxanib

Teilnahmeberechtigung

Kriterien:

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

Geschlecht: All

Mindestalter: 18 Years

Maximales Alter: N/A

Gesunde Freiwillige: No

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
David G. Pfister, MD Study Chair Memorial Sloan Kettering Cancer Center
Ort
Einrichtung: Memorial Sloan-Kettering Cancer Center
Standort Länder

United States

Überprüfungsdatum

December 2002

Schlüsselwörter
Hat den Zugriff erweitert No
Bedingung Durchsuchen
Studiendesign Info

Hauptzweck: Treatment

Quelle: ClinicalTrials.gov