Trastuzumab Plus Chemotherapy in Treating Patients With Advanced Non-small Cell Lung Cancer

June 20, 2013 updated by: Eastern Cooperative Oncology Group

Phase II Pilot Trial of Carboplatin, Paclitaxel, and Herceptin in HER2/Neu (+) Advanced NSCLC

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of the monoclonal antibody trastuzumab plus carboplatin and paclitaxel in treating patients who have advanced non-small cell lung cancer.

Study Overview

Status

Completed

Conditions

Lung Cancer

Intervention / Treatment

Detailed Description

OBJECTIVES: I. Assess the toxicity of monoclonal antibody HER2 with carboplatin and paclitaxel in patients with HER2 positive non-small cell lung cancer. II. Determine median time to progression and one year freedom from progression in this patient population. III. Evaluate one year survival rate and overall objective response rate in this patient population.

OUTLINE: Patients receive paclitaxel IV over 3 hours immediately followed by carboplatin IV over 30 minutes immediately followed by monoclonal antibody HER2 IV over 30-90 minutes on day 1. Patients also receive monoclonal antibody HER2 on days 8 and 15. Treatment is repeated every 3 weeks for 6 courses. After 6 courses of treatment, patients may receive monoclonal antibody HER2 weekly for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years and once a year thereafter until disease progression or death.

PROJECTED ACCRUAL: A total of 22-44 patients will be accrued for this study.

Study Type

Interventional

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Puerto Rico
- - San Juan, Puerto Rico, 00927-5800
    - MBCCOP - San Juan
  - San Juan, Puerto Rico, 00927-5800
    - Veterans Affairs Medical Center - San Juan
South Africa
- - Pretoria, South Africa, 0001
    - Pretoria Academic Hospital
United States
- Arizona
  - Scottsdale, Arizona, United States, 85259-5404
    - CCOP - Scottsdale Oncology Program
- California
  - Los Angeles, California, United States, 91010
    - Beckman Research Institute, City of Hope
  - Palo Alto, California, United States, 94304
    - Veterans Affairs Medical Center - Palo Alto
  - Stanford, California, United States, 94305-5408
    - Stanford University Medical Center
- Colorado
  - Denver, Colorado, United States, 80209-5031
    - CCOP - Colorado Cancer Research Program, Inc.
- Delaware
  - Wilmington, Delaware, United States, 19899
    - CCOP - Christiana Care Health Services
- District of Columbia
  - Washington, District of Columbia, United States, 20307-5000
    - Walter Reed Army Medical Center
- Florida
  - Gainesville, Florida, United States, 32608-1197
    - Veterans Affairs Medical Center - Gainsville
  - Miami, Florida, United States, 33136
    - Sylvester Cancer Center, University of Miami
  - Tampa, Florida, United States, 33612
    - H. Lee Moffitt Cancer Center and Research Institute
  - Tampa, Florida, United States, 33612
    - Veterans Affairs Medical Center - Tampa (Haley)
- Georgia
  - Atlanta, Georgia, United States, 30322
    - Emory University Hospital - Atlanta
  - Decatur, Georgia, United States, 30033
    - Veterans Affairs Medical Center - Atlanta (Decatur)
- Illinois
  - Chicago, Illinois, United States, 60611
    - Robert H. Lurie Comprehensive Cancer Center, Northwestern University
  - Chicago, Illinois, United States, 60611
    - Veterans Affairs Medical Center - Chicago (Lakeside)
  - Decatur, Illinois, United States, 62526
    - CCOP - Central Illinois
  - Evanston, Illinois, United States, 60201
    - CCOP - Evanston
  - Peoria, Illinois, United States, 61602
    - CCOP - Illinois Oncology Research Association
  - Urbana, Illinois, United States, 61801
    - CCOP - Carle Cancer Center
- Indiana
  - Indianapolis, Indiana, United States, 46202-5265
    - Indiana University Cancer Center
  - Indianapolis, Indiana, United States, 46202
    - Veterans Affairs Medical Center - Indianapolis (Roudebush)
- Iowa
  - Cedar Rapids, Iowa, United States, 52403-1206
    - CCOP - Cedar Rapids Oncology Project
  - Des Moines, Iowa, United States, 50309-1016
    - CCOP - Iowa Oncology Research Association
- Kansas
  - Wichita, Kansas, United States, 67214-3882
    - CCOP - Wichita
- Louisiana
  - New Orleans, Louisiana, United States, 70112
    - MBCCOP - LSU Medical Center
  - New Orleans, Louisiana, United States, 70121
    - CCOP - Ochsner
- Maryland
  - Baltimore, Maryland, United States, 21287
    - Johns Hopkins Oncology Center
- Massachusetts
  - Boston, Massachusetts, United States, 02215
    - Beth Israel Deaconess Medical Center
  - Boston, Massachusetts, United States, 02111
    - New England Medical Center Hospital
- Michigan
  - Ann Arbor, Michigan, United States, 48106
    - CCOP - Ann Arbor Regional
  - Kalamazoo, Michigan, United States, 49007-3731
    - CCOP - Kalamazoo
- Minnesota
  - Duluth, Minnesota, United States, 55805
    - CCOP - Duluth
  - Minneapolis, Minnesota, United States, 55417
    - Veterans Affairs Medical Center - Minneapolis
  - Rochester, Minnesota, United States, 55905
    - Mayo Clinic Cancer Center
  - Saint Louis Park, Minnesota, United States, 55416
    - CCOP - Metro-Minnesota
- Nebraska
  - Omaha, Nebraska, United States, 68131
    - CCOP - Missouri Valley Cancer Consortium
- Nevada
  - Las Vegas, Nevada, United States, 89106
    - CCOP - Southern Nevada Cancer Research Foundation
- New Jersey
  - East Orange, New Jersey, United States, 07018-1095
    - Veterans Affairs Medical Center - East Orange
  - Hackensack, New Jersey, United States, 07601
    - CCOP - Northern New Jersey
  - New Brunswick, New Jersey, United States, 08901
    - Cancer Institute Of New Jersey
- New York
  - Albany, New York, United States, 12208
    - Veterans Affairs Medical Center - Albany
  - Bronx, New York, United States, 10461
    - Albert Einstein Comprehensive Cancer Center
  - Brooklyn, New York, United States, 11209
    - Veterans Affairs Medical Center - Brooklyn
  - New York, New York, United States, 10016
    - Kaplan Cancer Center
  - New York, New York, United States, 10010
    - Veterans Affairs Medical Center - New York
  - Rochester, New York, United States, 14642
    - University of Rochester Cancer Center
- North Dakota
  - Fargo, North Dakota, United States, 58122
    - CCOP - Merit Care Hospital
- Ohio
  - Cleveland, Ohio, United States, 44106-5065
    - Ireland Cancer Center
  - Cleveland, Ohio, United States, 44106
    - Veterans Affairs Medical Center - Cleveland
  - Columbus, Ohio, United States, 43206
    - CCOP - Columbus
  - Toledo, Ohio, United States, 43623-3456
    - CCOP - Toledo Community Hospital Oncology Program
- Oklahoma
  - Tulsa, Oklahoma, United States, 74136
    - CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center
- Pennsylvania
  - Danville, Pennsylvania, United States, 17822-2001
    - CCOP - Geisinger Clinical and Medical Center
  - Philadelphia, Pennsylvania, United States, 19111
    - Fox Chase Cancer Center
  - Philadelphia, Pennsylvania, United States, 19102-1192
    - Allegheny University Hospitals- Hahnemann
  - Philadelphia, Pennsylvania, United States, 19104
    - University of Pennsylvania Cancer Center
  - Philadelphia, Pennsylvania, United States, 19107
    - Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
  - Pittsburgh, Pennsylvania, United States, 15213
    - University of Pittsburgh Cancer Institute
  - Pittsburgh, Pennsylvania, United States, 15240
    - Veterans Affairs Medical Center - Pittsburgh
  - Wynnewood, Pennsylvania, United States, 19096
    - CCOP - MainLine Health
- South Dakota
  - Sioux Falls, South Dakota, United States, 57105-1080
    - CCOP - Sioux Community Cancer Consortium
- Tennessee
  - Nashville, Tennessee, United States, 37232-6838
    - Vanderbilt Cancer Center
  - Nashville, Tennessee, United States, 37212
    - Veterans Affairs Medical Center - Nashville
- Wisconsin
  - Madison, Wisconsin, United States, 53705
    - Veterans Affairs Medical Center - Madison
  - Madison, Wisconsin, United States, 53792
    - University of Wisconsin Comprehensive Cancer Center
  - Marshfield, Wisconsin, United States, 54449
    - CCOP - Marshfield Medical Research and Education Foundation
  - Milwaukee, Wisconsin, United States, 53226
    - Medical College of Wisconsin
  - Milwaukee, Wisconsin, United States, 53295
    - Veterans Affairs Medical Center - Milwaukee (Zablocki)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS: Histologically confirmed non-small cell lung cancer (NSCLC) Recurrent AND/OR Stage IIIB with pleural or pericardial effusion OR Stage IV Must have at least one bidimensionally measurable lesion Must be HER2 positive (1-3+) Brain metastases allowed, if symptoms controlled and not requiring steroids Prior/Concurrent Therapy-- Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for NSCLC Endocrine therapy: No concurrent steroids Radiotherapy: At least 2 weeks since prior radiotherapy Surgery: Not specified

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Transaminases no greater than 5 times upper limit of normal Renal: Creatinine no greater than 2 mg/dL Cardiovascular: No uncontrolled angina pectoris and arrhythmias No myocardial infarction within past 3 months No uncompensated congestive heart failure Ejection fraction at least 45% Other: No active infections Not pregnant or nursing Fertile patients must use effective contraception HIV negative No other active malignancies No evidence of peripheral sensory neuropathy of at least grade 2

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eastern Cooperative Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair: Corey J. Langer, MD, Fox Chase Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Langer CJ, Stephenson P, Thor A, Vangel M, Johnson DH; Eastern Cooperative Oncology Group Study 2598. Trastuzumab in the treatment of advanced non-small-cell lung cancer: is there a role? Focus on Eastern Cooperative Oncology Group study 2598. J Clin Oncol. 2004 Apr 1;22(7):1180-7. doi: 10.1200/JCO.2004.04.105. Epub 2004 Feb 23.
Huang C, Stephenson P, Langer CJ, et al.: Trastuzumab in combination with paclitaxel/carboplatin in advanced non-small cell lung cancer: final report of ECOG 2598. [Abstract] Lung Cancer 41 (Suppl 2): A-P628, S251, 2003.
Schiller J, Langer CJ, Thor A, et al.: Trastuzumab in combination with paclitaxel/carboplatin advanced non-small cell lung cancer: final report of ECOG 2598. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-2606, 2003.
Langer CJ, Adak S, Thor A, et al.: Phase II Eastern Cooperative Oncology Group (ECOG) pilot study of paclitaxel (P), carboplatin (C), and trastuzumab (T) in HER-2/neu (+) advanced non-small cell lung cancer (NSCLC): early analysis of E2598. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-1257, 2001.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 1999

Study Completion (Actual)

July 1, 2004

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

July 16, 2004

First Posted (Estimate)

July 19, 2004

Study Record Updates

Last Update Posted (Estimate)

June 21, 2013

Last Update Submitted That Met QC Criteria

June 20, 2013

Last Verified

March 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

CDR0000067048
ECOG-2598

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.