A Two-Stage Phase 1 Dose Escalation Pharmacokinetic Study of Tarceva in Patients With Stage IIIB/IV Non-small Cell Lung Cancer Who Continue to Smoke After Failure of One or Two Prior Chemotherapy Regimens
NSCLC
About this trial
This is an interventional treatment trial for NSCLC focused on measuring lung cancer, erlotinib, NSCLC, smokers
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed diagnosis of stage IIIB/IV NSCLC; Must have received 1 or 2 prior chemotherapy regimens for advanced NSCLC and now have progressive disease; Must have recovered from any treatment-related toxicities prior to registration, except for alopecia, grade 1 fatigue, or grade 1 neurotoxicity; A current cigarette smoker (minimum of 10 cigarettes per day for >= 1 year and have a positive test for cotinine) despite advice and support to quit; Age >= 18 years; ECOG PS 0-1 and predicted life expectancy >= 12 weeks; Previous surgery is permitted provided that wound healing has occurred prior to registration; Adequate hematopoietic, hepatic and renal function defined as follows: ANC >= 1.5 x 10^9/L, platelets >= 100 x 10^9/L, bilirubin <= 1.5 x ULN, ALT <= 2.5 x ULN (or 5 x ULN in case of liver metastases), creatinine <= 1.5 x ULN; No prior treatment with Tarceva or gefitinib (or other drug with significant activity against EGFR (eg, cetuximab and/or ZD6474)); Patients with reproductive potential must practice effective contraceptive measures throughout the study. Women of child-bearing potential must provide a negative pregnancy test within 14 days prior to registration; Accessible for repeat dosing and follow-up. Exclusion Criteria: Any concurrent anticancer cytostatic or cytotoxic chemotherapy; Concomitant CYP3A4 or CYP1A2 inducers/inhibitors (or during 14 days prior to study) with the exception of tobacco; Other active malignancies, unless disease-free and without cancer-specific therapy for at least the last 5 years. Basal or squamous cell skin cancers are not excluded; Significant history of cardiac disease unless the disease is well-controlled; Active or uncontrolled infections or serious illnesses or medical conditions that could interfere with the patient's ongoing participation in the study; History of any psychiatric condition that might impair the patient's ability to understand or comply with the requirements; of the study or to provide informed consent. Gastrointestinal abnormalities, including inability to take oral medication, requirement for IV alimentation, active peptic ulcer or prior surgical procedures affecting absorption; Clinically significant ophthalmologic abnormalities; Pregnant or breast-feeding females. Males or females not practicing effective birth control; Symptomatic brain metastases which are not stable, require steroids, or that have required radiation within the last 28 days; History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study drug;
Sites / Locations
- Comprehensive Blood and Cancer Center
- Wake Forest University Comprehensive Cancer Center
- University of Edinburgh,Division of Oncology,
- Aberdeen Royal Infirmary
- Ninewells Hospital
- Beatson West of Scotland Cancer Centre
- Sir Bobby Robson Cancer Trials Research Centre
- Department of Oncology
- Royal Marsden Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Arm A
Arm B
Arm A (Tarceva MTD established in Part I)
Arm B (150 mg Tarceva daily).