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| ID | Type | Description | Link |
|---|---|---|---|
| ECOG-2598 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| trastuzumab | Biological | |||
| carboplatin | Drug | |||
| paclitaxel | Drug |
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
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| Name | Affiliation | Role |
|---|---|---|
| Corey J. Langer, MD | Fox Chase Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CCOP - Scottsdale Oncology Program | Scottsdale | Arizona | 85259-5404 | United States | ||
| Beckman Research Institute, City of Hope |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14981103 | Result | 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. | |
| Result | 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. | ||
| Result | 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. | ||
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| Los Angeles |
| California |
| 91010 |
| United States |
| Veterans Affairs Medical Center - Palo Alto | Palo Alto | California | 94304 | United States |
| Stanford University Medical Center | Stanford | California | 94305-5408 | United States |
| CCOP - Colorado Cancer Research Program, Inc. | Denver | Colorado | 80209-5031 | United States |
| CCOP - Christiana Care Health Services | Wilmington | Delaware | 19899 | United States |
| Walter Reed Army Medical Center | Washington D.C. | District of Columbia | 20307-5000 | United States |
| Veterans Affairs Medical Center - Gainsville | Gainesville | Florida | 32608-1197 | United States |
| Sylvester Cancer Center, University of Miami | Miami | Florida | 33136 | United States |
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612 | United States |
| Veterans Affairs Medical Center - Tampa (Haley) | Tampa | Florida | 33612 | United States |
| Emory University Hospital - Atlanta | Atlanta | Georgia | 30322 | United States |
| Veterans Affairs Medical Center - Atlanta (Decatur) | Decatur | Georgia | 30033 | United States |
| Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago | Illinois | 60611 | United States |
| Veterans Affairs Medical Center - Chicago (Lakeside) | Chicago | Illinois | 60611 | United States |
| CCOP - Central Illinois | Decatur | Illinois | 62526 | United States |
| CCOP - Evanston | Evanston | Illinois | 60201 | United States |
| CCOP - Illinois Oncology Research Association | Peoria | Illinois | 61602 | United States |
| CCOP - Carle Cancer Center | Urbana | Illinois | 61801 | United States |
| Indiana University Cancer Center | Indianapolis | Indiana | 46202-5265 | United States |
| Veterans Affairs Medical Center - Indianapolis (Roudebush) | Indianapolis | Indiana | 46202 | United States |
| CCOP - Cedar Rapids Oncology Project | Cedar Rapids | Iowa | 52403-1206 | United States |
| CCOP - Iowa Oncology Research Association | Des Moines | Iowa | 50309-1016 | United States |
| CCOP - Wichita | Wichita | Kansas | 67214-3882 | United States |
| MBCCOP - LSU Medical Center | New Orleans | Louisiana | 70112 | United States |
| CCOP - Ochsner | New Orleans | Louisiana | 70121 | United States |
| Johns Hopkins Oncology Center | Baltimore | Maryland | 21287 | United States |
| New England Medical Center Hospital | Boston | Massachusetts | 02111 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| CCOP - Ann Arbor Regional | Ann Arbor | Michigan | 48106 | United States |
| CCOP - Kalamazoo | Kalamazoo | Michigan | 49007-3731 | United States |
| CCOP - Duluth | Duluth | Minnesota | 55805 | United States |
| Veterans Affairs Medical Center - Minneapolis | Minneapolis | Minnesota | 55417 | United States |
| Mayo Clinic Cancer Center | Rochester | Minnesota | 55905 | United States |
| CCOP - Metro-Minnesota | Saint Louis Park | Minnesota | 55416 | United States |
| CCOP - Missouri Valley Cancer Consortium | Omaha | Nebraska | 68131 | United States |
| CCOP - Southern Nevada Cancer Research Foundation | Las Vegas | Nevada | 89106 | United States |
| Veterans Affairs Medical Center - East Orange | East Orange | New Jersey | 07018-1095 | United States |
| CCOP - Northern New Jersey | Hackensack | New Jersey | 07601 | United States |
| Cancer Institute of New Jersey | New Brunswick | New Jersey | 08901 | United States |
| Veterans Affairs Medical Center - Albany | Albany | New York | 12208 | United States |
| Veterans Affairs Medical Center - Brooklyn | Brooklyn | New York | 11209 | United States |
| Veterans Affairs Medical Center - New York | New York | New York | 10010 | United States |
| Kaplan Cancer Center | New York | New York | 10016 | United States |
| University of Rochester Cancer Center | Rochester | New York | 14642 | United States |
| Albert Einstein Comprehensive Cancer Center | The Bronx | New York | 10461 | United States |
| CCOP - Merit Care Hospital | Fargo | North Dakota | 58122 | United States |
| Ireland Cancer Center | Cleveland | Ohio | 44106-5065 | United States |
| Veterans Affairs Medical Center - Cleveland | Cleveland | Ohio | 44106 | United States |
| CCOP - Columbus | Columbus | Ohio | 43206 | United States |
| CCOP - Toledo Community Hospital Oncology Program | Toledo | Ohio | 43623-3456 | United States |
| CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center | Tulsa | Oklahoma | 74136 | United States |
| CCOP - Geisinger Clinical and Medical Center | Danville | Pennsylvania | 17822-2001 | United States |
| Allegheny University Hospitals- Hahnemann | Philadelphia | Pennsylvania | 19102-1192 | United States |
| University of Pennsylvania Cancer Center | Philadelphia | Pennsylvania | 19104 | United States |
| Kimmel Cancer Center of Thomas Jefferson University - Philadelphia | Philadelphia | Pennsylvania | 19107 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| University of Pittsburgh Cancer Institute | Pittsburgh | Pennsylvania | 15213 | United States |
| Veterans Affairs Medical Center - Pittsburgh | Pittsburgh | Pennsylvania | 15240 | United States |
| CCOP - MainLine Health | Wynnewood | Pennsylvania | 19096 | United States |
| CCOP - Sioux Community Cancer Consortium | Sioux Falls | South Dakota | 57105-1080 | United States |
| Veterans Affairs Medical Center - Nashville | Nashville | Tennessee | 37212 | United States |
| Vanderbilt Cancer Center | Nashville | Tennessee | 37232-6838 | United States |
| Veterans Affairs Medical Center - Madison | Madison | Wisconsin | 53705 | United States |
| University of Wisconsin Comprehensive Cancer Center | Madison | Wisconsin | 53792 | United States |
| CCOP - Marshfield Medical Research and Education Foundation | Marshfield | Wisconsin | 54449 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Veterans Affairs Medical Center - Milwaukee (Zablocki) | Milwaukee | Wisconsin | 53295 | United States |
| MBCCOP - San Juan | San Juan | 00927-5800 | Puerto Rico |
| Veterans Affairs Medical Center - San Juan | San Juan | 00927-5800 | Puerto Rico |
| Pretoria Academic Hospital | Pretoria | 0001 | South Africa |
| 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. |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
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| ID | Term |
|---|---|
| D000068878 | Trastuzumab |
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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