NCT00294736CompletedPhase 1
A Two-Stage Phase 1 Dose Escalation Pharmacokinetic Study of Tarceva® (Erlotinib) in Patients With Stage IIIB/IV Non-small Cell Lung Cancer Who Continue To Smoke After Failure of One or Two Prior Chemotherapy Regimens
OSI Pharmaceuticals9 sites in 2 countries57 target enrollmentStarted: November 2005Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 57
- Locations
- 9
- Primary Endpoint
- To establish the MTD of Tarceva in currently smoking patients with stage IIIB/IV NSCLC.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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;
Arms & Interventions
Arm A
Experimental
Arm A (Tarceva MTD established in Part I)
Intervention: Tarceva (Drug)
Arm B
Experimental
Arm B (150 mg Tarceva daily).
Intervention: Tarceva (Drug)
Outcomes
Primary Outcomes
To establish the MTD of Tarceva in currently smoking patients with stage IIIB/IV NSCLC.
Time Frame: 2 years
Secondary Outcomes
- To evaluate the survival of currently smoking patients with stage IIIB/IV NSCLC when given Tarceva at the MTD and 150 mg.(2 years)
Investigators
Study Sites (9)
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