SU5416 and Paclitaxel in Treating Patients With Recurrent, Locally Advanced or Metastatic Cancer … (NCT00005647) | Clinical Trial Compass
CompletedPhase 1
SU5416 and Paclitaxel in Treating Patients With Recurrent, Locally Advanced or Metastatic Cancer of the Head and Neck
United States12 participantsStarted 2000-05
Plain-language summary
RATIONALE: SU5416 may stop the growth of head and neck cancer by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining SU5416 with chemotherapy may kill more cancer cells.
PURPOSE: Phase I trial to study the effectiveness of SU5416 and paclitaxel in treating patients who have recurrent, locally advanced, or metastatic cancer of the head and neck.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Metastatic or loco-regionally recurrent malignancy of the head and neck (including salivary gland and thyroid) that is incurable by surgery or radiotherapy
* At least two distinct tumor masses OR
* One tumor mass at least 3 cm in diameter
* No brain metastases
* No pulmonary metastases as only site of disease
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-2
Life expectancy:
* At least 12 weeks
Hematopoietic:
* WBC at least 3,500/mm3
* Granulocyte count at least 1,500/mm3
* Platelet count at least 100,000/mm3
* Hemoglobin greater than 9.0 g/dL
Hepatic:
* PT and PTT normal OR
* INR ratio less than 1.1
* Bilirubin less than 1.5 mg/dL
* AST and ALT less than 2 times upper limit of normal
Renal:
* Creatinine less than 1.5 mg/dL
* Creatinine clearance greater than 60 mL/min
Cardiovascular:
* No New York Heart Association class III or IV heart disease
* No uncompensated coronary artery disease
* No history of myocardial infarction or severe or unstable angina within the past 6 months
* No severe peripheral vascular disease
* No deep venous thrombosis or arterial thrombosis within the past 6 months
* No known hypercoagulable syndrome with predisposition to venous or arterial clots
Pulmonary:
* No pulmonary embolism within the past 6 months
Other:
* No prior cerebral hemorrhage
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biolo…
What they're measuring
1
Determine the maximum tolerated dose and safety of SU5416 and paclitaxel.
Timeframe: Treatment continues weekly in the absence of disease progression or unacceptable toxicity.