Phase II Trial of OSI-774 (NSC-718781) in Patients With Advanced Non-Small Cell Lung Cancer and a Performance Status of 2
Overview
- Phase
- Phase 2
- Intervention
- erlotinib hydrochloride
- Conditions
- Adenocarcinoma of the Lung
- Sponsor
- National Cancer Institute (NCI)
- Enrollment
- 65
- Locations
- 1
- Primary Endpoint
- Median survival
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
This phase II trial is studying how well erlotinib works in treating patients with advanced primary non-small cell lung cancer. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth
Detailed Description
PRIMARY OBJECTIVES: I. To assess survival in patients with advanced non-small cell lung carcinoma with a Zubrod Performance Status of 2 treated with OSI-774. II. To evaluate the objective tumor response rates (confirmed plus unconfirmed, complete and partial), in patients with advanced non-small cell lung carcinoma with a Zubrod Performance Status of 2 treated with OSI-774. III. To investigate in a preliminary manner possible correlations of EGFR expression, mutations, and/or EGFR polymorphisms with response and/or survival. IV. To investigate in a preliminary manner possible correlations of activated signal pathway molecules, including basal p27 expression levels with response and/or survival. OUTLINE: This is a multicenter study. Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients must have histologically or cytologically proven newly diagnosed selected stage IIIB (T4 lesion due to malignant pleural effusion) or stage IV, advanced primary non-small cell lung cancer (adenocarcinoma, large cell carcinoma, squamous cell carcinoma or unspecified) or recurrent disease after previous surgery and/or irradiation
- •Patients with brain metastases are ineligible; all patients with neurological abnormalities on physical exam or symptoms must have a negative pretreatment CT or MRI scan of the brain within 28 days prior to registration
- •Patients must have measurable disease documented by CT, MRI, X-ray, physical exam or nuclear exam within 28 days prior to registration; non-measurable disease must be assessed within 42 days prior to registration
- •Patients must have a Zubrod performance status of 2
- •Patients may have received prior radiation therapy provided that at least three weeks have elapsed since the completion of prior radiation therapy and patients have recovered from all associated toxicities; measurable disease must be present outside the previous radiation field or a new lesion must be present
- •Patients may have received prior surgery provided that at least three weeks have elapsed since surgery (thoracic or other major surgeries) and patients have recovered from all associated toxicities; patients must have measurable residual disease present outside the area of surgical resection
- •Patients must not have received prior hormonal, systemic (chemotherapy) or biologic therapy for non-small cell lung cancer; patients must not have received prior therapy with EGFR inhibitors
- •Patients must not be currently receiving or planning to receive concurrent hormonal, biologic or radiation therapy to measurable or non-measurable lesions except patients may receive concurrent palliative radiation therapy to small field non-measurable sites of disease (painful bony metastases) as long as there are other sites of measurable disease outside of the radiation treatment field
- •ANC of \>= 1,500/ul
- •Platelet count of \>= 100,000/ul
Exclusion Criteria
- Not provided
Arms & Interventions
Treatment
Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Intervention: erlotinib hydrochloride
Treatment
Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Intervention: laboratory biomarker analysis
Outcomes
Primary Outcomes
Median survival
Time Frame: Up to 3 years
Secondary Outcomes
- Response rates (confirmed plus unconfirmed, complete plus partial)(Up to 3 years)
- Toxicity rates graded according to the NCI CTCAE version 3.0(Up to 3 years)