Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
A Phase I Study of the Raf Kinase/VEGFR Inhibitor BAY 43-9006 in Combination With the Proteasome Inhibitor PS-341 in Patients With Advanced Malignancies
This phase I trial is studying the side effects and best dose of sorafenib and bortezomib in treating patients with advanced cancer. Sorafenib and bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Sorafenib may also stop the growth of cancer cells by blocking blood flow to the cancer
OBJECTIVES:
I. To determine the maximum tolerated dose (MTD) of sorafenib and bortezomib in patients
with advanced malignancies.
II. To describe the toxicities associated with the combination of sorafenib and bortezomib.
III. To evaluate the therapeutic antitumor activity of the combination of sorafenib and
bortezomib.
IV. To evaluate the effects of sorafenib on the disposition of bortezomib.
OUTLINE: This is a dose-escalation study. Patients are assigned to 1 of 2 groups according
to disease type.
GROUP I (solid tumors-dose-escalation group): Patients receive oral sorafenib twice daily on
days 1-21 and bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every
21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6
patients receive escalating doses of sorafenib and bortezomib until the MTD is determined.
The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience
dose-limiting toxicity.
GROUP II (multiple myeloma or chronic lymphocytic leukemia-maximum tolerated dose [MTD]
group): Patients receive oral sorafenib at the MTD twice daily on days 3-21 of course 1 and
on days 1-21 of each subsequent course. Patients also receive bortezomib IV over 3-5 seconds
at the MTD on days 1, 4, 8, and 11.
Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for 3 months.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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