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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00294736
Recruitment Status : Completed
First Posted : February 22, 2006
Last Update Posted : August 8, 2012
Information provided by (Responsible Party):
Astellas Pharma Inc ( OSI Pharmaceuticals )

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

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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

Resource links provided by the National Library of Medicine

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

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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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;

Information from the National Library of Medicine

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 identifier (NCT number): NCT00294736

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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
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Study Director: Medical Monitor OSI Pharmaceuticals

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Responsible Party: OSI Pharmaceuticals 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

Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action