Lung CancerPhase 2NCT00003881
Trastuzumab Plus Chemotherapy in Treating Patients With Advanced Non-small Cell Lung Cancer
A Phase 2 study testing trastuzumab, carboplatin and paclitaxel in people with Lung Cancer, run by Eastern Cooperative Oncology Group at 71 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- trastuzumab, carboplatin and paclitaxel
- How many people
- Not given
- Where
- 71 sitesin 3 countries
- Study dates
- May 1999to Jul 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
71 sites in 3 countries.
71 sites in 3 countries
United States68 sites
Veterans Affairs Medical Center - Albany
Albany, New York, 12208
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, 48106
Emory University Hospital - Atlanta
Atlanta, Georgia, 30322
Johns Hopkins Oncology Center
Baltimore, Maryland, 21287
New England Medical Center Hospital
Boston, Massachusetts, 02111
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Veterans Affairs Medical Center - Brooklyn
Brooklyn, New York, 11209
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611
Veterans Affairs Medical Center - Chicago (Lakeside)
Chicago, Illinois, 60611
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
Veterans Affairs Medical Center - Cleveland
Cleveland, Ohio, 44106
CCOP - Columbus
Columbus, Ohio, 43206
CCOP - Geisinger Clinical and Medical Center
Danville, Pennsylvania, 17822-2001
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur, Georgia, 30033
CCOP - Central Illinois
Decatur, Illinois, 62526
CCOP - Colorado Cancer Research Program, Inc.
Denver, Colorado, 80209-5031
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
CCOP - Duluth
Duluth, Minnesota, 55805
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, 07018-1095
CCOP - Evanston
Evanston, Illinois, 60201
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122
Veterans Affairs Medical Center - Gainsville
Gainesville, Florida, 32608-1197
CCOP - Northern New Jersey
Hackensack, New Jersey, 07601
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5265
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis, Indiana, 46202
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
Beckman Research Institute, City of Hope
Los Angeles, California, 91010
Veterans Affairs Medical Center - Madison
Madison, Wisconsin, 53705
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792
CCOP - Marshfield Medical Research and Education Foundation
Marshfield, Wisconsin, 54449
Sylvester Cancer Center, University of Miami
Miami, Florida, 33136
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, 53295
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, 55417
Veterans Affairs Medical Center - Nashville
Nashville, Tennessee, 37212
Vanderbilt Cancer Center
Nashville, Tennessee, 37232-6838
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
MBCCOP - LSU Medical Center
New Orleans, Louisiana, 70112
CCOP - Ochsner
New Orleans, Louisiana, 70121
Veterans Affairs Medical Center - New York
New York, New York, 10010
Kaplan Cancer Center
New York, New York, 10016
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68131
Veterans Affairs Medical Center - Palo Alto
Palo Alto, California, 94304
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61602
Allegheny University Hospitals- Hahnemann
Philadelphia, Pennsylvania, 19102-1192
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15213
Veterans Affairs Medical Center - Pittsburgh
Pittsburgh, Pennsylvania, 15240
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
University of Rochester Cancer Center
Rochester, New York, 14642
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, 55416
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, 85259-5404
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57105-1080
Stanford University Medical Center
Stanford, California, 94305-5408
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
Veterans Affairs Medical Center - Tampa (Haley)
Tampa, Florida, 33612
Albert Einstein Comprehensive Cancer Center
The Bronx, New York, 10461
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, 43623-3456
CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center
Tulsa, Oklahoma, 74136
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
CCOP - Wichita
Wichita, Kansas, 67214-3882
CCOP - Christiana Care Health Services
Wilmington, Delaware, 19899
CCOP - MainLine Health
Wynnewood, Pennsylvania, 19096
Puerto Rico2 sites
MBCCOP - San Juan
San Juan, 00927-5800
Veterans Affairs Medical Center - San Juan
San Juan, 00927-5800
About this study
Official title: 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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- trastuzumab, carboplatin, paclitaxel
- Keywords
- recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trastuzumabBiological
carboplatinDrug
paclitaxelDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2004 (estimated)
- Study startMay 1999
- Study completionJul 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Eastern Cooperative Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Corey J. Langer, MD, Study chair, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003881
- Sponsor's protocol ID
- CDR0000067048
- Other IDs
- ECOG-2598
- Status last verified
- Mar 2004
- First submitted
- 1 Nov 1999
- Last updated
- 21 Jun 2013
- Results posted
- No
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.
PubMed 14981103Huang 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 at a glance
From the registry record, last updated by the sponsor on 21 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Pilot Trial of Carboplatin, Paclitaxel, and Herceptin in HER2/Neu (+) Advanced NSCLC
- ClinicalTrials.gov ID
- NCT00003881
- Acronym / sponsor ID
- CDR0000067048
- Conditions
- Lung Cancer
- Keywords
- recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Eastern Cooperative Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 1999
- Study completion
- Jul 2004 (actual)
- First posted
- 19 Jul 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| trastuzumab | Biological | – |
| carboplatin | Drug | – |
| paclitaxel | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2013.
- Results publication: PubMed 14981103Langer 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.
- Results publicationHuang 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.
- Results publicationSchiller 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.
- Results publicationLanger 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Corey J. Langer, MD study chair
Fox Chase Cancer Center
71 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing trastuzumab, carboplatin and paclitaxel in people with Lung Cancer, run by Eastern Cooperative Oncology Group at 71 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 71 sites in United States, Puerto Rico, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00003881, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2013.