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


Phase 2
18 Years
N/A
Not Enrolling
Both
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
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.

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:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Corey J. Langer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000067048

NCT ID:

NCT00003881

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

Name

Location

Albert Einstein Comprehensive Cancer CenterBronx, New York  10461
Kaplan Cancer CenterNew York, New York  10016
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Stanford University Medical CenterStanford, California  94305-5408
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Emory University Hospital - AtlantaAtlanta, Georgia  30322
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Johns Hopkins Oncology CenterBaltimore, Maryland  21287
CCOP - Ann Arbor RegionalAnn Arbor, Michigan  48106
University of Rochester Cancer CenterRochester, New York  14642
Ireland Cancer CenterCleveland, Ohio  44106-5065
Kimmel Cancer Center of Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania  19104
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicago, Illinois  60611
Sylvester Cancer Center, University of MiamiMiami, Florida  33136
CCOP - WichitaWichita, Kansas  67214-3882
MBCCOP - LSU Medical CenterNew Orleans, Louisiana  70112
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
CCOP - Christiana Care Health ServicesWilmington, 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 AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
Veterans Affairs Medical Center - Indianapolis (Roudebush)Indianapolis, Indiana  46202
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
New England Medical Center HospitalBoston, Massachusetts  02111
CCOP - KalamazooKalamazoo, Michigan  49007-3731
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Veterans Affairs Medical Center - East OrangeEast Orange, New Jersey  07018-1095
CCOP - Northern New JerseyHackensack, New Jersey  07601
University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15213
CCOP - DuluthDuluth, Minnesota  55805
Vanderbilt Cancer CenterNashville, Tennessee  37232-6838
CCOP - Scottsdale Oncology ProgramScottsdale, Arizona  85259-5404
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
CCOP - OchsnerNew Orleans, Louisiana  70121
CCOP - Merit Care HospitalFargo, North Dakota  58122
CCOP - Toledo Community Hospital Oncology ProgramToledo, Ohio  43623-3456
CCOP - Geisinger Clinical and Medical CenterDanville, Pennsylvania  17822-2001
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080
Medical College of WisconsinMilwaukee, Wisconsin  53226
Beckman Research Institute, City of HopeLos Angeles, California  91010
CCOP - Central IllinoisSpringfield, Illinois  62526
Veterans Affairs Medical Center - AlbanyAlbany, New York  12208
CCOP - ColumbusColumbus, Ohio  43206
Allegheny University Hospitals- HahnemannPhiladelphia, Pennsylvania  19102-1192
CCOP - MainLine HealthWynnewood, Pennsylvania  19096
Veterans Affairs Medical Center - MadisonMadison, Wisconsin  53705
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Veterans Affairs Medical Center - Milwaukee (Zablocki)Milwaukee, Wisconsin  53295
CCOP - EvanstonEvanston, Illinois  60201
Veterans Affairs Medical Center - New YorkNew York, New York  10010
CCOP - Marshfield Medical Research and Education FoundationMarshfield, Wisconsin  54449
Veterans Affairs Medical Center - Chicago (Lakeside)Chicago, Illinois  60611
Veterans Affairs Medical Center - PittsburghPittsburgh, Pennsylvania  15240
Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
Veterans Affairs Medical Center - MinneapolisMinneapolis, Minnesota  55417
Veterans Affairs Medical Center - Palo AltoPalo Alto, California  94304
Veterans Affairs Medical Center - ClevelandCleveland, Ohio  44106
Veterans Affairs Medical Center - NashvilleNashville, Tennessee  37212
Veterans Affairs Medical Center - BrooklynBrooklyn, New York  11209
Veterans Affairs Medical Center - Tampa (Haley)Tampa, Florida  33612
CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer CenterTulsa, Oklahoma  74136
Veterans Affairs Medical Center - GainsvilleGainesville, Florida  32608-1197