NCT00072072

Brief Summary

RATIONALE: Celecoxib may stop the growth of cancer by stopping blood flow to the tumor. Erlotinib and celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining celecoxib with erlotinib may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of celecoxib when given together with erlotinib in treating patients with stage IIIB or stage IV non-small cell lung cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Aug 2003

Shorter than P25 for phase_1 lung-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 6, 2003

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
Last Updated

September 20, 2013

Status Verified

January 1, 2006

First QC Date

November 4, 2003

Last Update Submit

September 19, 2013

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancerstage IIIB non-small cell lung cancerstage IV non-small cell lung cancer

Interventions

celecoxibDRUG
erlotinib hydrochlorideDRUG

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed non-small cell lung cancer (NSCLC) * Stage IIIB or IV * Measurable disease * Progressive disease after at least 2 prior standard chemotherapy regimens OR refused standard chemotherapy * No active CNS metastases PATIENT CHARACTERISTICS: Age * 21 and over Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic * Bilirubin no greater than 1.5 mg/dL * Transaminases no greater than 2.5 times upper limit of normal (ULN) * PT and/or PTT no greater than 1.5 times ULN Renal * Creatinine no greater than 2 mg/dL Cardiovascular * No New York Heart Association class III or IV cardiac disease * No myocardial infarction within the past year * No symptomatic ventricular arrhythmia * No symptomatic conduction abnormality Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No prior gastrointestinal ulceration, bleeding, or perforation * No hypersensitivity to celecoxib, sulfonamides, aspirin, other NSAIDs, or other reagents used in this study * No concurrent disease or medical condition that would preclude study treatment or compliance PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics * More than 4 weeks since prior chemotherapy Endocrine therapy * More than 4 weeks since prior corticosteroids * No concurrent steroids (including chronic use) * Concurrent topical steroids allowed Radiotherapy * More than 4 weeks since prior radiotherapy Surgery * Not specified Other * More than 4 weeks since prior non-cytotoxic investigational agents * More than 3 days since prior nonsteroidal anti-inflammatory drugs (NSAIDs) * No prior cyclooxygenase-2 (COX-2) inhibitors for metastatic NSCLC * No prior epidermal growth factor receptor inhibitor for metastatic NSCLC * No concurrent COX-2 inhibitors * No concurrent NSAIDs * No concurrent fluconazole or lithium

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

Sponsors & Collaborators

Study Sites (1)

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1781, United States

Location

Related Publications (1)

  • Reckamp KL, Krysan K, Morrow JD, Milne GL, Newman RA, Tucker C, Elashoff RM, Dubinett SM, Figlin RA. A phase I trial to determine the optimal biological dose of celecoxib when combined with erlotinib in advanced non-small cell lung cancer. Clin Cancer Res. 2006 Jun 1;12(11 Pt 1):3381-8. doi: 10.1158/1078-0432.CCR-06-0112.

    PMID: 16740761RESULT

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

CelecoxibErlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Robert A. Figlin, MD, FACP

    Jonsson Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

  • Karen Rickard

    City of Hope Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 4, 2003

First Posted

November 6, 2003

Study Start

August 1, 2003

Study Completion

January 1, 2006

Last Updated

September 20, 2013

Record last verified: 2006-01

Locations

US(1)