Status:
COMPLETED
Gemcitabine, Cisplatin, and Gefitinib in Treating Patients Who Are Undergoing Surgery for Stage III Non-Small Cell Lung Cancer
Lead Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Gefit...
Detailed Description
OBJECTIVES: Primary * Determine the therapeutic activity of neoadjuvant induction therapy comprising gemcitabine, cisplatin, and gefitinib in patients with stage IIIA non-small cell lung cancer unde...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed primary non-small cell lung cancer (NSCLC)
- Clinical stage IIIA by chest CT scan
- Unresectable N2 disease by mediastinoscopy, mediastinotomy, thoracotomy, or video-assisted thoracic surgery
- Measurable disease
- At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
- Planning to undergo lobectomy or pneumonectomy after induction therapy
- No N3 or metastatic disease by physical exam, thoracic CT scan, bone scan, and CT scan or ultrasound of the liver and adrenal glands
- No pleural or pericardial effusion
- No superior vena cava syndrome
- No diffuse interstitial pulmonary fibrosis
- No signs or symptoms of CNS involvement
- PATIENT CHARACTERISTICS:
- Age
- Over 18
- Performance status
- WHO 0-2
- Life expectancy
- Not specified
- Hematopoietic
- Absolute neutrophil count \> 1,500/mm\^3
- Platelet count \> 100,000/mm\^3
- Hepatic
- AST and ALT ≤ 1.5 times upper limit of normal (ULN)
- Bilirubin normal
- Alkaline phosphatase ≤ 2.5 times ULN
- Renal
- Creatinine ≤ 1.25 times ULN
- Creatinine clearance ≥ 60 mL/min
- Cardiovascular
- No medically uncontrolled congestive heart failure or angina pectoris
- No uncontrolled hypertension or arrhythmia
- No myocardial infarction within the past year
- Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- Physically and mentally fit to receive gemcitabine- and cisplatin-containing chemotherapy
- Physiologically fit to undergo surgery
- No uncontrolled, active infection requiring IV antibiotics
- No history of hypersensitivity to gefitinib or any of its excipients
- No motor or sensory neurotoxicity ≥ grade 2
- No other primary malignancy within the past 5 years except carcinoma in situ of the cervix or adequately treated basal cell skin cancer
- No prior melanoma, breast cancer, or renal cell cancer
- No psychological, familial, sociological, or geographical condition that would preclude study compliance
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- No concurrent immunotherapy
- Chemotherapy
- No prior chemotherapy for NSCLC
- No other concurrent chemotherapy
- Endocrine therapy
- No concurrent antiestrogen therapy
- Concurrent replacement steroids and antiemetic steroids allowed
- Radiotherapy
- No prior radiotherapy for NSCLC
- Surgery
- See Disease Characteristics
- No prior surgery for NSCLC
- Other
- More than 1 month since prior and no concurrent investigational agents
- No other prior therapy for NSCLC
- No concurrent CYP3A4 inducers, including any of the following:
- Phenytoin
- Carbamazepine
- Rifampin
- Barbiturates (e.g., phenobarbital)
- Hypericum perforatum (St. John's wort)
- No concurrent systemic retinoids
- No other concurrent antitumor therapy
Exclusion
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00103051
Start Date
December 1 2004
Last Update
July 16 2012
Active Locations (1)
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1
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Amsterdam, Netherlands