Sorafenib and Bortezomib in Treating Patients With Advanced Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Bortezomib; Niacinamide; Proteasome Inhibitors; Sorafenib

Criteria

Inclusion Criteria:

• 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

• Medically capable and willing to provide biologic specimens as required (mandatory for patients in group II)

• Priorbortezomib allowed

• More than 3 weeks since prior chemotherapy (6 weeks for mitomycin C or nitrosoureas) and recovered

• More than 4 weeks since prior immunotherapy or biologic therapy

• More than 2 weeks since prior steroid therapy (group II only)

• No prior anti-vascular endothelial growth factor therapy

• More than 4 weeks since prior full-field radiotherapy (2 weeks for limited-field radiotherapy)

• No prior radiation to > 25% of bone marrow

• More than 4 weeks since major surgery (e.g., laparotomy) (2 weeks for minor surgery)

• Insertion of a vascular access device is not considered major or minor surgery

• No concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary other therapy considered investigational

• No concurrent prophylactic colony-stimulating factors

• No concurrent therapeutic anticoagulation

• Concurrent prophylactic anticoagulation (i.e., low-dose warfarin) of venous or arterial access devices allowed provided requirements for PT, INR, or PTT are met

• No concurrent cytochrome P450 enzyme-inducing antiepileptic drugs (e.g., phenytoin, carbamazepine, and phenobarbital), rifampin, or Hypericum perforatum (St. John's Wort)

• No concurrent participation in any other study involving a pharmacologic agent (e.g., drugs, biologics, immunotherapy, or gene therapy), either for symptom control, or therapeutic intent