Status:
COMPLETED
Bortezomib and Celecoxib in Treating Patients With Advanced Solid Tumors
Lead Sponsor:
Medical University of South Carolina
Conditions:
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18-120 years
Phase:
PHASE1
Brief 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. PUR...
Detailed Description
OBJECTIVES: Primary * Determine the maximum tolerated dose (MTD) of bortezomib and celecoxib in patients with advanced solid tumors. Secondary * Determine the overall pattern of toxicities associa...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2009
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00290680
Start Date
March 1 2005
End Date
January 1 2009
Last Update
April 10 2018
Active Locations (1)
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1
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States, 29425