Bortezomib and Celecoxib in Treating Patients With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00290680
Recruitment Status : Completed
First Posted : February 13, 2006
Last Update Posted : April 10, 2018
Information provided by (Responsible Party):
Medical University of South Carolina

February 9, 2006
February 13, 2006
April 10, 2018
March 2005
January 2009   (Final data collection date for primary outcome measure)
Maximum tolerated dose
Not Provided
Complete list of historical versions of study NCT00290680 on Archive Site
Response and disease progression by RECIST criteria before each course
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Bortezomib and Celecoxib in Treating Patients With Advanced Solid Tumors
Phase I Trial of Bortezomib (VELCADE™) and Celecoxib in Patients With Advanced Solid Tumors

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.



  • Determine the maximum tolerated dose (MTD) of bortezomib and celecoxib in patients with advanced solid tumors.


  • 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.

Phase 1
Primary Purpose: Treatment
Unspecified Adult Solid Tumor, Protocol Specific
  • Drug: bortezomib
  • Drug: celecoxib
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Not Provided
January 2009
January 2009   (Final data collection date for primary outcome measure)


  • 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


  • 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


  • 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
Sexes Eligible for Study: All
18 Years to 120 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Medical University of South Carolina
Medical University of South Carolina
Not Provided
Study Chair: Andrew S. Kraft, MD Medical University of South Carolina
Study Chair: Gustavo Leone Medical University of South Carolina, Hollings Cancer Center
Medical University of South Carolina
April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP