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

Lung Cancer Clinical Trial

Official title:

A Phase III, Randomized, Double Blind, Multicenter Trial of Tarceva (Erlotinib) Plus Chemotherapy (Carboplatin and Paclitaxel) Versus Chemotherapy Alone in Patients With Advanced (Stage IIIb or IV) Non-Small Cell Lung Cancer Who Have Not Received Prior Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00047736
• Other study ID #: OSI2298g
• Status: Completed
• Phase: Phase 3
• First received: October 16, 2002
• Last updated: June 19, 2013
• Start date: July 2001
• Est. completion date: July 2003

Study information

• Verified date: June 2013
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT00029016

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: July 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• Tarceva (erlotinib HCl)

Locations

Country	Name	City	State
United States	Multinational Sites	Denver	Colorado
United States	Trial Information Center	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 lun — View Citation