Cisplatin and Gemcitabine Plus Trastuzumab in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
| Status: | Completed |
|---|---|
| Conditions: | Lung Cancer, Lung Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/28/2018 |
| Start Date: | May 13, 1999 |
| End Date: | December 14, 2004 |
Phase II Multidose, Single Arm, Multicenter Clinical Trial of Cisplatin and Gemcitabine in Combination With Recombinant Humanized Anti-p185HER2 Monoclonal Antibody (Herceptin) in Patients Who Have Untreated p185HER2 Overexpressing Advanced Local Stage (Stage IIIb Pleural Effusion Only) and Metastatic (Stage IV) Non-Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells
and either kill them or deliver tumor-killing substances to them without harming normal
cells. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells.
PURPOSE: Phase II trial to study effectiveness of combining cisplatin, gemcitabine, and
trastuzumab in treating patients who have stage IIIB or stage IV non-small cell lung cancer.
they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells
and either kill them or deliver tumor-killing substances to them without harming normal
cells. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells.
PURPOSE: Phase II trial to study effectiveness of combining cisplatin, gemcitabine, and
trastuzumab in treating patients who have stage IIIB or stage IV non-small cell lung cancer.
OBJECTIVES: I. Determine the therapeutic efficacy and toxicity of cisplatin, gemcitabine, and
trastuzumab (Herceptin) in patients with untreated p185-HER2 overexpressing stage IIIB or IV
non-small cell lung cancer. II. Determine the pharmacokinetic interactions among these drugs
in these patients. III. Assess the pharmacodynamics of these drugs in these patients.
OUTLINE: This is a multicenter study. Regimen A: Patients receive gemcitabine IV over 30
minutes followed by cisplatin IV over 2 hours on day 1 and trastuzumab (Herceptin) IV over 90
minutes on day 2. Patients receive trastuzumab IV over 90 minutes followed by gemcitabine IV
over 30 minutes on day 8 and trastuzumab IV over 90 minutes on day 15. Patients proceed to
regimen B on day 22 of regimen A. Regimen B: Patients receive trastuzumab IV over 30-90
minutes, gemcitabine IV over 30 minutes, and cisplatin IV over 2 hours on day 1. Patients
receive trastuzumab IV over 30-90 minutes followed by gemcitabine IV over 30 minutes on day 8
and trastuzumab IV over 30-90 minutes on day 15. Treatment repeats every 21 days for up to 5
courses in the absence of disease progression or unacceptable toxicity. Maintenance: After
completion of 6 courses, patients with stable disease or partial response receive trastuzumab
IV over 30-90 minutes weekly until tumor progression.
PROJECTED ACCRUAL: A total of 20-48 patients will be accrued for this study.
trastuzumab (Herceptin) in patients with untreated p185-HER2 overexpressing stage IIIB or IV
non-small cell lung cancer. II. Determine the pharmacokinetic interactions among these drugs
in these patients. III. Assess the pharmacodynamics of these drugs in these patients.
OUTLINE: This is a multicenter study. Regimen A: Patients receive gemcitabine IV over 30
minutes followed by cisplatin IV over 2 hours on day 1 and trastuzumab (Herceptin) IV over 90
minutes on day 2. Patients receive trastuzumab IV over 90 minutes followed by gemcitabine IV
over 30 minutes on day 8 and trastuzumab IV over 90 minutes on day 15. Patients proceed to
regimen B on day 22 of regimen A. Regimen B: Patients receive trastuzumab IV over 30-90
minutes, gemcitabine IV over 30 minutes, and cisplatin IV over 2 hours on day 1. Patients
receive trastuzumab IV over 30-90 minutes followed by gemcitabine IV over 30 minutes on day 8
and trastuzumab IV over 30-90 minutes on day 15. Treatment repeats every 21 days for up to 5
courses in the absence of disease progression or unacceptable toxicity. Maintenance: After
completion of 6 courses, patients with stable disease or partial response receive trastuzumab
IV over 30-90 minutes weekly until tumor progression.
PROJECTED ACCRUAL: A total of 20-48 patients will be accrued for this study.
DISEASE CHARACTERISTICS: Immunohistochemically confirmed p185-HER2 expressing stage IIIB
(pleural effusions only) or IV non-small cell lung cancer Confirmed overexpression at
least: 1+ p185-HER2 (by DAKO Hercep Test) OR 15 ng/mL serum HER2/neu shed antigen (by Human
HER2 Quantitative ELISA) At least 1 site of measurable disease outside of prior radiation
port Brain metastases allowed provided clinical neurologic status is stable and head CT
scan is stable to improved
PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Zubrod 0-2 Life expectancy: More
than 12 weeks Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least
1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL (transfusion
allowed) Hepatic: Bilirubin less than 1.5 mg/dL SGPT no greater than 1.5 times normal
Renal: Creatinine clearance at least 60 mL/min Cardiovascular: No myocardial infarction
within the past 6 months No unstable angina, uncontrolled congestive heart failure, or
uncontrolled arrhythmia Ejection fraction at least 40% Other: No other malignancy within
the past 5 years No concurrent serious infection, including post-obstructive pneumonia No
more than 10% weight loss in past 3 months Not pregnant or nursing Negative pregnancy test
Fertile patients must use adequate contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy No other concurrent chemotherapy Endocrine therapy: Not specified
Radiotherapy: See Disease Characteristics At least 3 weeks since prior radiotherapy
(including radiotherapy for brain metastases) No concurrent radiotherapy to only site of
measurable disease Surgery: At least 2 weeks since prior major surgery No concurrent
surgery on only site of measurable disease
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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