Etoposide and Celecoxib in Patients With Advanced Cancer

NCT00551005 | Completed Phase 1

• 4 other identifiers: 01036P30CA033572CHNMC-01036CDR0000570381
• Study Type: interventional
• Target: 58
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Etoposide and celecoxib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving more than 1 drug may be an effective treatment for advanced cancer. PURPOSE: This phase I trial is studying the side effects and best dose of celecoxib when given together with etoposide in treating patients with advanced cancer.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (4)

• Toxicity

• Maximum tolerated dose

• Survival

• Time to failure

Interventions

celecoxib DRUG

etoposide DRUG

immunoenzyme technique OTHER

laboratory biomarker analysis OTHER

Eligibility Criteria

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

You may qualify if:

• WHO performance status 0-2
• Life expectancy ≥ 3 months
• ANC \> 1.5 x 10\^9/L
• Platelet count \> 100 x 10\^9/L
• Creatinine clearance \> 50 mL/min
• Serum bilirubin \< 1.5 mg/dL
• AST and ALT \< 2.0 times upper limit of normal (unless clearly due to the presence of tumor)
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Patient must be capable of understanding the nature of the trial and must give written informed consent

You may not qualify if:

• Unstable or severe intercurrent medical conditions or active, uncontrolled infection
• History of allergic reactions to non-steroidal anti-inflammatory drugs (NSAIDs)
• History of bleeding peptic ulcer within the past 3 months
• PRIOR CONCURRENT THERAPY:
• Recovered from all prior chemotherapy or radiotherapy
• Concurrent aspirin for cardiovascular indications allowed
• More than 2 weeks since prior and no other concurrent NSAIDs
• Had radiotherapy or chemotherapy within 3 weeks (nitrosoureas or mitomycin C within 6 weeks) prior to anticipated first day of dosing
• Undergoing concurrent therapy with other investigational agents or antineoplastic therapy

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Interventions

Celecoxib; Etoposide; Immunoenzyme Techniques

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Immunoassay; Immunologic Techniques; Investigative Techniques; Immunohistochemistry; Molecular Probe Techniques

Study Officials

• Przemyslaw W. Twardowski, MD

  City of Hope Comprehensive 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: October 25, 2007
• First Posted: October 30, 2007
• Study Start: December 1, 2001
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: November 22, 2012

Record last verified: 2012-11