Status:
COMPLETED
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
Lead Sponsor:
OSI Pharmaceuticals
Conditions:
NSCLC
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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) ...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT00294736
Start Date
November 1 2005
End Date
September 1 2007
Last Update
August 8 2012
Active Locations (9)
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1
Comprehensive Blood and Cancer Center
Bakersfield, California, United States, 93309
2
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157
3
University of Edinburgh,Division of Oncology,
Edinburgh, Scotland, United Kingdom, EH4 2XU
4
Aberdeen Royal Infirmary
Aberdeen, United Kingdom, AB25 2ZN