Sorafenib and Bortezomib in Treating Patients With Advanced Cancer

Completed · Phase 1

Conditions studied: Refractory Chronic Lymphocytic Leukemia, Refractory Multiple Myeloma, Stage III Multiple Myeloma, Stage IV Chronic Lymphocytic Leukemia, Unspecified Adult Solid Tumor, Protocol Specific

In brief

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

Key facts

Study ID

NCT00303797

Run by

National Cancer Institute (NCI)

People needed

50

Starts

2005-12-01

Last updated by the study team

2013-03-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of 1 of the following:
• Cytologically or histologically proven unresectable solid tumor for which no curative treatment options exist (group I - dose-escalation phase)
• Multiple myeloma or chronic lymphocytic leukemia requiring treatment (group II - maximum tolerated dose phase)
• Failed ≥ 1 prior regimen
• Non-secretory myeloma allowed
• No known standard therapy that is potentially curative or definitely capable of extending life expectancy exists
• Tumor amenable to serial sampling (group II)
• ECOG performance status 0-2
• Absolute neutrophil count ≥ 1,500/mm\^3
• Hemoglobin ≥ 9 g/dL
• Platelet count ≥ 100,000/mm\^3 (75,000/mm\^3 for patients with multiple myeloma [group II])
• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• AST ≤ 3 times ULN (5 times ULN if liver involvement)
• Creatinine ≤ 1.5 times ULN (2.5 times ULN for patients with multiple myeloma [group II])
• Life expectancy ≥ 12 weeks
• No uncontrolled infection
• No New York Heart Association class III or IV heart disease
• No uncontrolled hypertension, labile hypertension, or history of poor compliance with antihypertensive medication
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No sensory peripheral neuropathy of any etiology > grade 1 or neuropathic pain of any etiology
• No active HIV infection requiring therapy
• No inability to swallow that would preclude use of oral medications
• No evidence of bleeding diathesis

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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