Bortezomib and Celecoxib in Treating Patients With Advanced Solid Tumors - Full Text View

Sponsored by:	Medical University of South Carolina
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00290680

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 I

MedlinePlus related topics: Cancer

Drug Information available for: Celecoxib 4-(5-(4-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl)benzenesulfonamide Bortezomib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment
Official Title:	Phase I Trial of Bortezomib (VELCADE™) and Celecoxib in Patients With Advanced Solid Tumors

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Maximum tolerated dose [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Response and disease progression by RECIST criteria before each course [ Designated as safety issue: No ]

Estimated Enrollment:	36
Study Start Date:	March 2005
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00290680

Locations

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

Sponsors and Collaborators

Medical University of South Carolina

Investigators

Study Chair:

Andrew S. Kraft, MD

Medical University of South Carolina

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications of Results:

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.

Study ID Numbers:	CDR0000454922, MUSC-I065-341-03, MILLENNIUM-100825
Study First Received:	February 9, 2006
Last Updated:	November 8, 2008
ClinicalTrials.gov Identifier:	NCT00290680
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

unspecified adult solid tumor, protocol specific

Study placed in the following topic categories:

Celecoxib
Bortezomib

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Enzyme Inhibitors
Pharmacologic Actions
Protease Inhibitors

Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009