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
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ClinicalTrials.gov Identifier: NCT00294736 |
Recruitment Status :
Completed
First Posted : February 22, 2006
Last Update Posted : August 8, 2012
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
NSCLC | Drug: Tarceva | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 57 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | November 2005 |
Actual Primary Completion Date : | September 2007 |
Actual Study Completion Date : | September 2007 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm A
Arm A (Tarceva MTD established in Part I)
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Drug: Tarceva
Dose Escalation: 150-350+ mg/day |
Experimental: Arm B
Arm B (150 mg Tarceva daily).
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Drug: Tarceva
Dose Escalation: 150-350+ mg/day |
- To establish the MTD of Tarceva in currently smoking patients with stage IIIB/IV NSCLC. [ Time Frame: 2 years ]
- 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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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | 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;

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00294736
United States, California | |
Comprehensive Blood and Cancer Center | |
Bakersfield, California, United States, 93309 | |
United States, North Carolina | |
Wake Forest University Comprehensive Cancer Center | |
Winston-Salem, North Carolina, United States, 27157 | |
United Kingdom | |
University of Edinburgh,Division of Oncology, | |
Edinburgh, Scotland, United Kingdom, EH4 2XU | |
Aberdeen Royal Infirmary | |
Aberdeen, United Kingdom, AB25 2ZN | |
Ninewells Hospital | |
Dundee, United Kingdom, DD1 9SY | |
Beatson West of Scotland Cancer Centre | |
Glasgow, United Kingdom, G12 0YN | |
Sir Bobby Robson Cancer Trials Research Centre | |
Newcastle upon Tyne, United Kingdom, NE7 7DH | |
Department of Oncology | |
Sheffield, United Kingdom, S10 2SJ | |
Royal Marsden Hospital | |
Sutton, United Kingdom, SM2 5PT |
Study Director: | Medical Monitor | OSI Pharmaceuticals |
Responsible Party: | OSI Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00294736 History of Changes |
Other Study ID Numbers: |
OSI-774-107 2005-003883-46 ( EudraCT Number ) |
First Posted: | February 22, 2006 Key Record Dates |
Last Update Posted: | August 8, 2012 |
Last Verified: | August 2012 |
Keywords provided by Astellas Pharma Inc ( OSI Pharmaceuticals ):
lung cancer erlotinib NSCLC smokers |
Additional relevant MeSH terms:
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
Carcinoma, Bronchogenic Bronchial Neoplasms Erlotinib Hydrochloride Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |