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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
NSCLC	Drug: Tarceva	Phase 1

Study Design

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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

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Arm A; Arm A (Tarceva MTD established in Part I)	Drug: Tarceva; Dose Escalation: 150-350+ mg/day
Experimental: Arm B; Arm B (150 mg Tarceva daily).	Drug: Tarceva; Dose Escalation: 150-350+ mg/day

Outcome Measures

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Primary Outcome Measures :

1. To establish the MTD of Tarceva in currently smoking patients with stage IIIB/IV NSCLC. [ Time Frame: 2 years ]

Secondary Outcome Measures :

1. 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 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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;

Contacts and Locations

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Locations

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

Sponsors and Collaborators

OSI Pharmaceuticals

Investigators

Study Director:	Medical Monitor	OSI Pharmaceuticals

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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