Clinical trial · Interventional
Bortezomib and Celecoxib in Treating Patients With Advanced Solid Tumors
Phase I Trial of Bortezomib (VELCADE™) and Celecoxib in Patients With Advanced Solid Tumors
NCT00290680CI-TRIAL-00032452completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bortezomib | Drug | Bortezomib | ALIAS |
| celecoxib | Drug | Celecoxib | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Maximum tolerated dose
Secondary outcomes (1)
- measure
- Response and disease progression by RECIST criteria before each course
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTHayslip J, Chaudhary U, Green M, Meyer M, Dunder S, Sherman C, Salzer S, Kraft A, Montero AJ. Bortezomib in combination with celecoxib in patients with advanced solid tumors: a phase I trial. BMC Cancer. 2007 Dec 3;7:221. doi: 10.1186/1471-2407-7-221. PMID 18053191