Sorafenib in Treating Patients With Advanced Solid Tumors

Stopped early · Phase 1

Conditions studied: Unspecified Adult Solid Tumor, Protocol Specific

In brief

This randomized phase I trial is studying the side effects, such as high blood pressure, and best dose of sorafenib in treating patients with advanced solid tumors. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Key facts

Study ID

NCT00436579

Run by

National Cancer Institute (NCI)

People needed

110

Starts

2007-01-01

Last updated by the study team

2014-02-24

Who can join

Age: 14 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed malignant solid tumor
• Refractory disease for which curative or palliative measures have failed or for which there is no known superior treatment
• No colorectal cancer or melanoma
• Measurable OR nonmeasurable disease
• Normotensive (blood pressure [BP] ≤ 140/90 mm Hg) meeting 1 of the following criteria:
• No more than 2 attempted measurement sessions for which the documented mean systolic BP is ≤ 140 mm Hg and the diastolic BP is ≤ 90 mm Hg
• At least 30 attempted measurement sessions for which the documented mean systolic BP is ≤ 135 mm HG and the diastolic BP is ≤ 85 mm Hg
• Brain metastases allowed provided the following criteria are met:
• Stable neurologic status for ≥ 2 weeks after completion of definitive local therapy (surgery or radiotherapy)
• No neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
• ECOG performance status 0-1
• Life expectancy > 12 weeks
• Age ≥ 14 years OR weight ≥ 45 kilograms (pediatric patients)
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Hemoglobin ≥ 8.5 g/dL
• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• AST and ALT ≤ 2.5 times ULN (5 times ULN if there is liver involvement)
• Creatinine ≤ 1.5 times ULN
• No New York Heart Association class II-IV congestive heart failure
• No unstable angina (anginal symptoms at rest) or new-onset angina (began within the past 3 months)
• No myocardial infarction within the past 6 months

Where it is running

• University of Chicago — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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