Bortezomib and Celecoxib in Treating Patients With Advanced Solid Tumors

This study has been completed.
Sponsor:
Information provided by:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00290680
First received: February 9, 2006
Last updated: April 26, 2012
Last verified: April 2012

February 9, 2006
April 26, 2012
March 2005
January 2009   (final data collection date for primary outcome measure)
Maximum tolerated dose [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00290680 on ClinicalTrials.gov Archive Site
Response and disease progression by RECIST criteria before each course [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
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.

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.

Interventional
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
January 2009
January 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00290680
CDR0000454922, MUSC-I065-341-03, MILLENNIUM-100825
Yes
Not Provided
Medical University of South Carolina
Not Provided
Study Chair: Andrew S. Kraft, MD Medical University of South Carolina
Medical University of South Carolina
April 2012

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