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About
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving erlotinib together with carboplatin and paclitaxel may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying how well erlotinib works when given alone or together with carboplatin and paclitaxel in treating patients with stage IIIB or stage IV non-small cell lung cancer.
Full description
OBJECTIVES:
Primary
To select a regimen (erlotinib hydrochloride with or without carboplatin and paclitaxel) for further testing against standard treatment, based on median progression-free survival for ≥ 3 months, in patients with stage IIIB or IV non-small cell lung cancer with a Zubrod performance status of 2.
Secondary
To assess the feasibility of selecting patients for a trial based on central EGFR testing of serum in a cooperative group setting. To evaluate the objective tumor response rates (confirmed and unconfirmed, complete and partial response), in a subset of patients with measurable disease.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for 4 courses. Beginning in course 5 and for all subsequent courses, patients receive oral erlotinib hydrochloride alone on days 1-21. Courses with erlotinib hydrochloride repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 2 years.
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Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), including any of the following subtypes:
Newly diagnosed primary disease OR recurrent disease after prior surgery and/or radiotherapy, meeting 1 of the following staging criteria:
Measurable or nonmeasurable disease by CT scan, MRI, x-ray, physical exam, or nuclear scan
Shows evidence of EGFR tyrosine kinase inhibitor therapy benefit (i.e., "proteomics positive") prior to study registration
No untreated brain metastases
PATIENT CHARACTERISTICS:
Zubrod performance status 2
ANC ≥ 1,500/mm³
Platelet count ≥ 1,000/mm³
Serum bilirubin normal
SGOT or SGPT normal
Serum creatinine ≤ 2 times upper limit of normal OR creatinine clearance ≥ 50 mL/min
Willing to provide prior smoking history as requested on the prestudy form
No gastrointestinal (GI) tract disease resulting in an inability to take enteral medication
No malabsorption syndrome or requirement for IV alimentation
No uncontrolled inflammatory GI disease (e.g., Crohn's disease or ulcerative colitis)
No significant history of cardiac disease, including any of the following:
No other prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years
Not pregnant or nursing
Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Primary purpose
Allocation
Interventional model
Masking
59 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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