Celecoxib and Erlotinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on August 03, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lung Cancer
Intervention: celecoxib (Drug); erlotinib hydrochloride (Drug); anti-cytokine therapy (Procedure); antiangiogenesis therapy (Procedure); biological therapy (Procedure); enzyme inhibitor therapy (Procedure); growth factor antagonist therapy (Procedure); protein tyrosine kinase inhibitor therapy (Procedure)
Phase: Phase 1
Status: No longer recruiting
Sponsored by: Jonsson Comprehensive Cancer Center Official(s) and/or principal investigator(s):
Robert A. Figlin, MD, FACP, Principal Investigator, Affiliation: Jonsson Comprehensive Cancer Center
Karen Reckamp, MD, Principal Investigator, Affiliation: Jonsson Comprehensive Cancer Center
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.
Clinical Details
Official title:
A Phase I Trial Of A COX-2 Inhibitor (Celecoxib) In Combination With An EGFR Inhibitor (OSI-774) In Metastatic Non-Small Cell Lung Cancer
Study design: Interventional, Treatment
Detailed description:
OBJECTIVES:
Primary
* Determine the biologically active dose of celecoxib administered with erlotinib in patients with stage IIIB or IV non-small cell lung cancer.
* Determine the toxicity profile of this regimen in these patients.
Secondary
* Determine the clinical activity of this regimen, in terms of reduction in tumor burden, in these patients.
* Correlate biological endpoints with cyclooxygenase-2 and epidermal growth factor receptor inhibition in patients treated with this regimen.
OUTLINE: This is a nonrandomized, dose-escalation study of celecoxib.
Patients receive oral erlotinib once daily and oral celecoxib twice daily on days 1-28. Treatment repeats every 4 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may continue treatment beyond 2 courses at the investigator's discretion.
Cohorts of 3-6 patients receive escalating doses of celecoxib until the maximum tolerated dose (MTD) and biologically active dose (BAD) are determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity (DLT). The BAD is defined as the maximum decrease in the level of PGE_2 where no DLT occurs.
Patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 21-27 patients will be accrued for this study.
Eligibility
Minimum age: 21 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Jonsson Comprehensive Cancer Center at UCLA, Los Angeles, California 90095-1781, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Related publications: 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.
Starting date:
August 2003
Last updated: February 8, 2007
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