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Erlotinib vs. Standard Chemotherapy in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) and Eastern Cooperative Oncology Group (ECOG)Performance Status (PS) 2

Primary Purpose

Non-Small Cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tarceva (Trademark) (erlotinib HCl, OSI-774)
Combination carboplatin and paclitaxel
Sponsored by
OSI Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring Tarceva, NSCLC, EGFR, ECOG Performance Status 2, erlotinib, Non-Small Cell Lung Cancer, OSI-774

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Stage IIIB or IV Nonsmall cell lung cancer (NSCLC) No prior chemotherapy Eastern Cooperative Oncology Group (ECOG) Performance Status 2 Clinically or radiologically measurable disease per RECIST criteria Exclusion Criteria: Gastro-intestinal abnormalities Any concurrent anticancer therapy Prior treatment with epidermal growth factor receptor (EGFR) inhibitors of any kind Other active malignancies Uncontrolled brain metastases Severe abnormalities of the cornea Significant cardiac disease

Sites / Locations

  • California Cancer Care, Inc.
  • Sharp Clinical Oncology Research
  • Holy Cross Hospital
  • Mount Sinai Cancer Center
  • University of Miami
  • Evanston Northwestern Healthcare
  • Oncology/Hematology Associates of Central Illinois
  • Norton Healthcare, Inc.
  • Maryland Hematology/Oncology Associates
  • VA Sierra Nevada Health Care System
  • Weill Medical College of Cornell University
  • FEK Addo, PC
  • Gabrail Cancer Center
  • University Hospitals of Cleveland
  • Ohio State University
  • Thomas Jefferson University Hospital
  • Charleston Hematology Oncology
  • East Tennessee Oncology/Hematology, PC
  • Sarah Cannon Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Erlotinib

Standard Chemotherapy

Arm Description

Erlotinib tablets administered orally, 150 mg/day (starting dose) or 100 mg/day (reduced dose), continuous therapy

Paclitaxel 200 mg/m^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 - 30 minutes, both given on Day 1 every 21 days for 4 cycles

Outcomes

Primary Outcome Measures

Progression-free Survival
Median time until disease progression. Disease progression defined as radiological and/or symptomatic disease progression or death in absence of progression.

Secondary Outcome Measures

Overall Survival
Median number of months from first study treatment until time of death
Best Tumor Response
Change in size of tumor: Complete Response (CR) = no measurable tumor; Partial Response (PR) = 30% decrease in size of measurable tumor; Stable Disease (SD) = measurable tumor size has not changed; Progressive Disease (PD) = measurable tumor 20% larger than at baseline.

Full Information

First Posted
June 15, 2004
Last Updated
August 6, 2012
Sponsor
OSI Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00085839
Brief Title
Erlotinib vs. Standard Chemotherapy in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) and Eastern Cooperative Oncology Group (ECOG)Performance Status (PS) 2
Official Title
A Randomized Phase II Study of Single Agent Erlotinib [Tarceva (TM), OSI-774] Versus Standard Chemotherapy in Patients With Previously Untreated Advanced NSCLC and a Poor Performance Status
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OSI Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this noncomparative study is to obtain preliminary estimates of the efficacy of erlotinib and standard chemotherapy in patients with advanced, previously untreated nonsmall cell lung cancer (NSCLC) and an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 2. The study will also evaluate the safety of single-agent erlotinib in this patient population.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
Keywords
Tarceva, NSCLC, EGFR, ECOG Performance Status 2, erlotinib, Non-Small Cell Lung Cancer, OSI-774

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Erlotinib
Arm Type
Experimental
Arm Description
Erlotinib tablets administered orally, 150 mg/day (starting dose) or 100 mg/day (reduced dose), continuous therapy
Arm Title
Standard Chemotherapy
Arm Type
Active Comparator
Arm Description
Paclitaxel 200 mg/m^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 - 30 minutes, both given on Day 1 every 21 days for 4 cycles
Intervention Type
Drug
Intervention Name(s)
Tarceva (Trademark) (erlotinib HCl, OSI-774)
Intervention Description
Erlotinib tablets administered orally, 150 mg/day (starting dose) or 100 mg/day (reduced dose), continuous therapy
Intervention Type
Drug
Intervention Name(s)
Combination carboplatin and paclitaxel
Intervention Description
Paclitaxel 200 mg/m^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 - 30 minutes, both given on Day 1 every 21 days for 4 cycles
Primary Outcome Measure Information:
Title
Progression-free Survival
Description
Median time until disease progression. Disease progression defined as radiological and/or symptomatic disease progression or death in absence of progression.
Time Frame
Until time of disease progression (maximum 5 months)
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Median number of months from first study treatment until time of death
Time Frame
From first study treatment until time of death (maximum 26.8 months)
Title
Best Tumor Response
Description
Change in size of tumor: Complete Response (CR) = no measurable tumor; Partial Response (PR) = 30% decrease in size of measurable tumor; Stable Disease (SD) = measurable tumor size has not changed; Progressive Disease (PD) = measurable tumor 20% larger than at baseline.
Time Frame
While receiving study treatment (maximum 60 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Stage IIIB or IV Nonsmall cell lung cancer (NSCLC) No prior chemotherapy Eastern Cooperative Oncology Group (ECOG) Performance Status 2 Clinically or radiologically measurable disease per RECIST criteria Exclusion Criteria: Gastro-intestinal abnormalities Any concurrent anticancer therapy Prior treatment with epidermal growth factor receptor (EGFR) inhibitors of any kind Other active malignancies Uncontrolled brain metastases Severe abnormalities of the cornea Significant cardiac disease
Facility Information:
Facility Name
California Cancer Care, Inc.
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
Sharp Clinical Oncology Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Holy Cross Hospital
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Mount Sinai Cancer Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Evanston Northwestern Healthcare
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Oncology/Hematology Associates of Central Illinois
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
Norton Healthcare, Inc.
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Maryland Hematology/Oncology Associates
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
VA Sierra Nevada Health Care System
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Weill Medical College of Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
FEK Addo, PC
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58503
Country
United States
Facility Name
Gabrail Cancer Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
University Hospitals of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1240
Country
United States
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Charleston Hematology Oncology
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29403
Country
United States
Facility Name
East Tennessee Oncology/Hematology, PC
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Sarah Cannon Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18281658
Citation
Lilenbaum R, Axelrod R, Thomas S, Dowlati A, Seigel L, Albert D, Witt K, Botkin D. Randomized phase II trial of erlotinib or standard chemotherapy in patients with advanced non-small-cell lung cancer and a performance status of 2. J Clin Oncol. 2008 Feb 20;26(6):863-9. doi: 10.1200/JCO.2007.13.2720.
Results Reference
result
Links:
URL
http://www.osip.com
Description
OSI Pharmaceuticals website
URL
http://www.gene.com/gene/products/information/pdf/tarceva-prescribing.pdf
Description
Link to Prescribing Information

Learn more about this trial

Erlotinib vs. Standard Chemotherapy in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) and Eastern Cooperative Oncology Group (ECOG)Performance Status (PS) 2

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