NSCLC
Conditions
Keywords
lung cancer, erlotinib, NSCLC, smokers
Brief summary
This is a multicenter, open-label, randomized phase 1 study of escalating doses of Tarceva in patients with advanced NSCLC who currently smoke. Part I will establish the maximum tolerated dose (MTD) of Tarceva in current smokers. In Part II, patients will be randomized 1:1 to two treatment groups: Arm A (Tarceva MTD established in Part I) and Arm B (150 mg Tarceva daily). Patients in both arms will be treated for two weeks and then have pharmacokinetic samples collected on day 14. Part II is open as of Nov-2006.
Interventions
DRUGTarceva
Dose Escalation: 150-350+ mg/day
Sponsors
OSI Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To establish the MTD of Tarceva in currently smoking patients with stage IIIB/IV NSCLC. | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the survival of currently smoking patients with stage IIIB/IV NSCLC when given Tarceva at the MTD and 150 mg. | 2 years |
Countries
United Kingdom, United States
Outcome results
None listed