A Study With Tarceva and Chemotherapy vs. Chemotherapy Alone in Patients With Advanced Lung Cancer

NCT ID: NCT00047736

Last Updated: 2013-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-07-31
• Study Completion Date: 2003-07-31

Brief Summary

The purpose of this study is to determine if Tarceva plus standard chemotherapy is more effective than standard chemotherapy alone in the treatment of lung cancer.

Conditions

Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Tarceva (erlotinib HCl)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Signed informed consent
• Age >=18 years
• Histologically documented, unresectable, inoperable, locally advanced, recurrent or metastatic Stage IIIB or Stage IV Non-Small Cell Lung Cancer (NSCLC)
• A cytologic diagnosis is acceptable (i.e., FNA or pleural fluid cytology)
• Measurable or non-measurable disease
• ECOG performance status of 0 or 1
• Life expectancy of >=3 months
• >= 3 weeks since any prior surgery or radiotherapy (>=2 weeks for patients who receive <=30 Gy of radiotherapy involving <25% of the marrow reserve)
• Use of an effective means of contraception (women of childbearing potential)
• Able to comply with study and follow-up procedures

Exclusion Criteria

• Evidence of small cell, carcinoid, or mixed small cell/non-small cell histology
• Malignancies within 3 years except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer
• Symptomatic or untreated brain metastases
• Prior systemic chemotherapy for NSCLC
• Prior exposure to agents directed at the HER axis (e.g., ZD1839 [Iressa], C225 [Cetuximab], Trastuzumab [Herceptin])
• Unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months prior to Day 1, or serious cardiac arrhythmia requiring medication (patients with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia, are eligible)
• History of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the patient at high risk from treatment complications
• Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous (IV) alimentation, or prior surgical procedures affecting absorption
• Pregnancy or lactation

Any of the following abnormal baseline hematologic values:

• Granulocytes count <=1500/uL
• Platelet count <100,000/uL

Any of the following abnormal baseline liver function tests:

• Serum bilirubin >1.5× upper limit of normal (ULN)
• Serum ALT and AST >=2.5× ULN (>5× ULN if due to liver metastases)
• Alkaline phosphatase >=2.5× ULN

Other baseline laboratory values:

• Serum creatinine >1.5× ULN or creatinine clearance <60 mL/min
• Uncontrolled hypercalcemia (>11.5 mg/dL)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Multinational Sites

Denver, Colorado, United States

Trial Information Center

Denver, Colorado, United States

Countries

United States

References

Hirsch FR, Varella-Garcia M, Dziadziuszko R, Xiao Y, Gajapathy S, Skokan M, Lin M, O'Neill V, Bunn PA Jr. Fluorescence in situ hybridization subgroup analysis of TRIBUTE, a phase III trial of erlotinib plus carboplatin and paclitaxel in non-small cell lung cancer. Clin Cancer Res. 2008 Oct 1;14(19):6317-23. doi: 10.1158/1078-0432.CCR-08-0539.

Reference Type: RESULT

PMID: 18829515 (View on PubMed)

Other Identifiers

OSI2298g

Identifier Type: -

Identifier Source: org_study_id

NCT00029016

Identifier Type: -

Identifier Source: nct_alias