A Phase II Study of OSI 774 (IND Number 63383) in Combination With Celecoxib (Celebrex, Pharmacia) as Second-Line Therapy in Advanced Non-Small Cell Lung Cancer
Overview
- Phase
- Phase 2
- Intervention
- erlotinib hydrochloride
- Conditions
- Recurrent Non-small Cell Lung Cancer
- Sponsor
- National Cancer Institute (NCI)
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Response rate according to the Response Evaluation Criteria in Solid Tumors (RECIST)
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
This phase II trial is studying how well giving erlotinib together with celecoxib works in treating patients with recurrent stage IIIB or stage IV non-small cell lung cancer. Erlotinib and celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Celecoxib may slow the growth of a tumor by stopping blood flow to the tumor. Combining erlotinib with celecoxib may kill more tumor cells.
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Detailed Description
PRIMARY OBJECTIVES: I. Determine the response rate of patients with stage IIIB or IV recurrent non-small cell lung cancer treated with erlotinib and celecoxib as second-line therapy. SECONDARY OBJECTIVES: I. Determine the time to progression in patients treated with this regimen. II. Determine the survival duration of patients treated with this regimen. III. Determine the toxicity of this regimen in these patients. IV. Correlate the expression of epidermal growth factor receptor and cyclooxygenase-2 in tumor specimens with response, time to progression, and survival in patients treated with this regimen. OUTLINE: Patients are assigned to 1 of 2 treatment groups. Group 1: Patients receive oral erlotinib once daily and oral celecoxib twice daily. Group 2: Patients receive erlotinib as in group 1. Treatment in both groups continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months. PROJECTED ACCRUAL: A total of 40-80 patients will be accrued for this study within 10 months.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically or cytologically confirmed non-small cell lung cancer
- •Stage IIIB (malignant pleural effusion only) or IV
- •Recurrent disease that has progressed after 1 or 2 prior chemotherapy regimens (platinum- or nonplatinum-based)
- •At least 1 unidimensionally measurable lesion\*
- •At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
- •Must have tissue specimen available for assays
- •No brain metastases
- •Performance status - ECOG 0-2
- •Performance status - Karnofsky 60-100%
- •More than 3 months
Exclusion Criteria
- Not provided
Arms & Interventions
Group I (erlotinib hydrochloride, celecoxib)
Patients receive oral erlotinib once daily and oral celecoxib twice daily.
Intervention: erlotinib hydrochloride
Group I (erlotinib hydrochloride, celecoxib)
Patients receive oral erlotinib once daily and oral celecoxib twice daily.
Intervention: celecoxib
Group I (erlotinib hydrochloride, celecoxib)
Patients receive oral erlotinib once daily and oral celecoxib twice daily.
Intervention: laboratory biomarker analysis
Group II (erlotinib hydrochloride)
Patients receive erlotinib as in group 1.
Intervention: erlotinib hydrochloride
Group II (erlotinib hydrochloride)
Patients receive erlotinib as in group 1.
Intervention: laboratory biomarker analysis
Outcomes
Primary Outcomes
Response rate according to the Response Evaluation Criteria in Solid Tumors (RECIST)
Time Frame: From the start of treatment until disease progression/recurrence, assessed up to 5 years
Secondary Outcomes
- Overall survival(Up to 5 years)
- Toxicity as assessed by NCI Common Toxicity Criteria (CTC) version 2.0(Up to 5 years)
- Time to progression(Interval between start of treatment with erlotinib hydrochloride and celecoxib and the date on which progressive disease, assessed up to 5 years)
- Relationship between measures of treatment efficacy and EGFR and COX-2 levels(Up to 5 years)