- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00294736
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
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
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 Overview
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Aberdeen, United Kingdom, AB25 2ZN
- Aberdeen Royal Infirmary
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Dundee, United Kingdom, DD1 9SY
- Ninewells Hospital
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Glasgow, United Kingdom, G12 0YN
- Beatson West of Scotland Cancer Centre
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Newcastle upon Tyne, United Kingdom, NE7 7DH
- Sir Bobby Robson Cancer Trials Research Centre
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Sheffield, United Kingdom, S10 2SJ
- Department of Oncology
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Sutton, United Kingdom, SM2 5PT
- Royal Marsden Hospital
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Scotland
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Edinburgh, Scotland, United Kingdom, EH4 2XU
- University of Edinburgh,Division of Oncology,
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California
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Bakersfield, California, United States, 93309
- Comprehensive Blood And Cancer Center
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North Carolina
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Winston-Salem, North Carolina, United States, 27157
- Wake Forest University Comprehensive Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Arm A
Arm A (Tarceva MTD established in Part I)
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Dose Escalation: 150-350+ mg/day
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Experimental: Arm B
Arm B (150 mg Tarceva daily).
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Dose Escalation: 150-350+ mg/day
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To establish the MTD of Tarceva in currently smoking patients with stage IIIB/IV NSCLC.
Time Frame: 2 years
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2 years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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To evaluate the survival of currently smoking patients with stage IIIB/IV NSCLC when given Tarceva at the MTD and 150 mg.
Time Frame: 2 years
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2 years
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Medical Monitor, OSI Pharmaceuticals
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OSI-774-107
- 2005-003883-46 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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