Bortezomib and Celecoxib in Treating Patients With Advanced Solid Tumors

NCT00290680 | Completed Phase 1 DMC

• 3 other identifiers: CDR0000454922MUSC-I065-341-03MILLENNIUM-100825
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose

Secondary Outcomes (1)

• Response and disease progression by RECIST criteria before each course

Interventions

bortezomib DRUG

celecoxib DRUG

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (1)

• 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.

  PMID: 18053191 RESULT

MeSH Terms

Interventions

Bortezomib; Celecoxib

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzenesulfonamides; Sulfonamides; Amides; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles

Study Officials

• Andrew S. Kraft, MD

  Medical University of South Carolina

  STUDY CHAIR

• Gustavo Leone

  Medical University of South Carolina, Hollings Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2006
• First Posted: February 13, 2006
• Study Start: March 1, 2005
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: April 10, 2018

Record last verified: 2018-04

Locations

US (1)