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Celecoxib and Erlotinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
celecoxib
erlotinib hydrochloride
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jonsson Comprehensive Cancer Center at UCLA

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 4, 2003
Last Updated
September 19, 2013
Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00072072
Brief Title
Celecoxib and Erlotinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
January 2006
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
celecoxib
Intervention Type
Drug
Intervention Name(s)
erlotinib hydrochloride

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert A. Figlin, MD, FACP
Organizational Affiliation
Jonsson Comprehensive Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karen Rickard
Organizational Affiliation
City of Hope Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jonsson Comprehensive Cancer Center at UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16740761
Citation
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.
Results Reference
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Celecoxib and Erlotinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

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