CompletedPhase 2

Cisplatin and Gemcitabine Plus Trastuzumab in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

United States22 participantsStarted 1999-05-13

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 Dis…

What they're measuring

Efficacy of Cisplatin, Gemcitabine, + Trastuzumab in Untreated p185-HER2 Overexpressing Stage IIIB or IV Non-small Cell Lung Cancer

Timeframe: 21 days cycles for 6 courses

Trial details

NCT IDNCT00016367

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2004-12-14