Bortezomib and Celecoxib in Treating Patients With Advanced Solid Tumors
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Unspecified Adult Solid Tumor, Protocol Specific |
Drug: bortezomib Drug: celecoxib |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Phase I Trial of Bortezomib (VELCADE™) and Celecoxib in Patients With Advanced Solid Tumors |
- Maximum tolerated dose [ Designated as safety issue: Yes ]
- Response and disease progression by RECIST criteria before each course [ Designated as safety issue: No ]
| Estimated Enrollment: | 36 |
| Study Start Date: | March 2005 |
| Study Completion Date: | January 2009 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
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 associated with this combination, including the emergence of any cumulative toxicities, during multiple courses of this regimen.
- Describe the response rate and duration of response or disease stability during therapy in the subset of patients with measurable disease.
- Assess changes in plasma/serum sphingosine-1-phosphate, ceramide, and other markers of the apoptotic pathway before and during therapy.
OUTLINE: This is a dose-escalation study.
Patients receive bortezomib IV on days 1, 4, 8, and 11 or days 1, 8, 15, 22, and 29 and oral celecoxib twice daily on days 1-21 or 1-42. Courses repeat every 21 or 42 days in the absence of disease progression or unacceptable toxicity. Patients are evaluated every 2 courses. Patients achieving complete response (CR) receive 2 additional courses of therapy beyond CR.
Cohorts of 3-6 patients receive escalating doses of bortezomib and celecoxib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
After completion of study treatment, patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, South Carolina | |
| Hollings Cancer Center at Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
| Study Chair: | Andrew S. Kraft, MD | Medical University of South Carolina |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00290680 History of Changes |
| Other Study ID Numbers: | CDR0000454922, MUSC-I065-341-03, MILLENNIUM-100825 |
| Study First Received: | February 9, 2006 |
| Last Updated: | April 26, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Medical University of South Carolina:
|
unspecified adult solid tumor, protocol specific |
Additional relevant MeSH terms:
|
Neoplasms Celecoxib Bortezomib Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Therapeutic Uses Central Nervous System Agents Antirheumatic Agents Antineoplastic Agents Protease Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013