Bortezomib and Celecoxib in Treating Patients With Advanced Solid Tumors

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Bortezomib and celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving bortezomib together with celecoxib may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib and celecoxib in treating patients with advanced solid tumors.

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

Details

• Lead Sponsor: Medical University of South Carolina
• Treatments: Bortezomib; Celecoxib

Criteria

DISEASE CHARACTERISTICS:

• Histologic or cytologic diagnosis of a malignant neoplasm (solid tumor) arising from any primary site with the exception of bone marrow or lymphoid tissue

• Recurrent or progressive disease after chemotherapy or radiotherapy

• Chemotherapy or radiotherapy-naive disease allowed if patient is not a candidate for standard treatment either due to comorbidities or lack of willingness to undergo standard treatment

• Measurable disease

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• Absolute neutrophil count ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

• Creatinine ≤ 2.0 mg/dL OR creatinine clearance ≥ 30 mL/min

• Bilirubin ≤ 2 mg/dL

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No active concurrent invasive malignancy

• No peripheral neuropathy ≥ grade 2 within the past 14 days

• No hypersensitivity to bortezomib, boron, mannitol, any of the cyclooxygenase (COX-2) inhibitors, sulfa drugs, or other nonsteroidal anti-inflammatory drugs (NSAIDs)

• No active gastrointestinal (GI) ulcers OR history of GI bleeding resulting from prior therapy with NSAIDs

PRIOR CONCURRENT THERAPY:

• At least 2 weeks since completion of prior radiotherapy

• No prior bortezomib

• No other concurrent investigational agents

• No concurrent chemotherapy, radiotherapy, or anticancer surgery

• No concurrent immune-enhancing therapy