Bortezomib and Celecoxib in Treating Patients With Advanced Solid Tumors (NCT00290680)

Study 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.

Read the 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 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.

Conditions studied

Unspecified Adult Solid Tumor, Protocol Specific

Browse trials for

Neoplasms 9,365

Keywords

unspecified adult solid tumor, protocol specific

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 36 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Medical University of South Carolina is the lead sponsor of 852 studies on the registry; 165 are open to participants now.

Of its 128 completed or terminated interventional studies of FDA-regulated products, 101 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 120 Years
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility 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

Study design

Phase: Phase 1
Primary purpose: Treatment
Enrollment: 36 participants (estimated)

Interventions

Drugbortezomib
Drugcelecoxib

What researchers measure

Primary outcomes

Maximum tolerated dose

Secondary outcomes

Response and disease progression by RECIST criteria before each course

Study locations

1 site

Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina 29425, United States

References and documents

Publications

Hayslip 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. PubMed 18053191 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 10, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00290680
Lead sponsor: Medical University of South Carolina
Responsible party: Sponsor
First posted: Feb 13, 2006
Start date: Mar 2005
Primary completion: Jan 2009
Completion: Jan 2009
Last update: Apr 10, 2018

Study contacts

Andrew S. Kraft, MD

study chair · Medical University of South Carolina

Gustavo Leone

study chair · Medical University of South Carolina, Hollings Cancer Center

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Bortezomib and Celecoxib in Treating Patients With Advanced Solid Tumors