Gemcitabine, Cisplatin, and Gefitinib in Treating Patients Who Are Undergoing Surgery for Stage III Non-Small Cell Lung Cancer

NCT00103051 | Completed Phase 2

• 2 other identifiers: EORTC-080132004-001332-23
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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. Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine and cisplatin together with gefitinib before surgery may shrink the tumor so it can be removed. PURPOSE: This phase II trial is studying how well giving gemcitabine and cisplatin together with gefitinib works in treating patients who are undergoing surgery for stage III non-small cell lung cancer.

Conditions

Lung Cancer

Keywords

stage IIIA non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Complete response rate as measured by RECIST criteria prior to surgery

Secondary Outcomes (2)

• Overall response rate as measured by RECIST criteria prior to surgery

• Toxicity as assessed by CTC

Interventions

cisplatin DRUG

gefitinib DRUG

gemcitabine hydrochloride DRUG

conventional surgery PROCEDURE

neoadjuvant therapy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (1)

Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

Amsterdam, Netherlands

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Cisplatin; Gefitinib; Gemcitabine; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Combined Modality Therapy; Therapeutics

Study Officials

• Nico Van Zandwijk, MD, PhD

  The Netherlands Cancer Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2005
• First Posted: February 8, 2005
• Study Start: December 1, 2004
• Primary Completion: November 1, 2005
• Last Updated: July 16, 2012

Record last verified: 2012-07

Locations

NL (1)