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

Phase 2
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

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

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

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.

Inclusion Criteria

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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Corey J. Langer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center


United States: Federal Government

Study ID:




Start Date:

May 1999

Completion Date:

July 2004

Related Keywords:

  • Lung Cancer
  • recurrent non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



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