Gefitinib as First-Line Therapy Followed by Gemcitabine and Cisplatin in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

NCT00217698 | Completed Phase 2 DMC

• 3 other identifiers: SAKK 19/03EU-20519ZENECA-AZ1839IL/0542
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 14

Brief Summary

RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving gefitinib as first-line therapy followed by gemcitabine and cisplatin after disease progression may be an effective treatment for non-small cell lung cancer. PURPOSE: This phase II trial is studying how well gefitinib works as first-line therapy followed by gemcitabine and cisplatin in treating patients with stage III or stage IV non-small cell lung cancer.

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; adenocarcinoma of the lung; large cell lung cancer; squamous cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Disease stabilization (complete response [CR], partial response [PR], or stable disease [SD]) after 12 weeks of study treatment

Secondary Outcomes (5)

• Disease stabilization (CR, PR, or SD) after 6 and 18 weeks of study treatment

• Objective response (CR and PR) to gefitinib treatment after weeks 6, 12, and 18

• Adverse reactions to gefitinib treatment measured after completion of study treatment

• Time to progression (TTP) with gefitinib treatment after completion of study treatment

• Event-free survival (EFS) with gefitinib treatment after completion of study treatment

Interventions

cisplatin DRUG

gefitinib DRUG

gemcitabine hydrochloride DRUG

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically\* or cytologically\* confirmed non-small cell lung cancer (NSCLC), including any of the following cellular subtypes: * Squamous cell carcinoma * Adenocarcinoma * Large cell carcinoma * Poorly differentiated NSCLC NOTE: \*New biopsies or cytologic specimens required for primary resection specimens older than 2 years * De novo or recurrent disease, meeting 1 of the following stage criteria: * Stage IIIB disease * Malignant pleural effusion OR supraclavicular node involvement (N3) * Not suitable for curative multimodal treatment or surgery * Stage IV disease * Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan or MRI * Measurable lesion must be outside previously irradiated areas * Immediate chemotherapy is not clinically mandatory * No small cell lung cancer (SCLC) or SCLC combined with NSCLC * No symptomatic and/or untreated brain metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * WHO 0-1 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 10.0 g/dL Hepatic * Bilirubin normal * AST or ALT ≤ 2.5 times upper limit of normal (ULN) * Alkaline phosphatase ≤ 2.5 times ULN (5 times ULN in the presence of bone metastases) * No unstable or uncompensated hepatic disease Renal * Creatinine clearance \> 60 mL/min * No unstable or uncompensated renal disease Cardiovascular * No unstable or uncompensated cardiac disease * No myocardial infarction within the past 3 months Pulmonary * No clinically active interstitial lung disease * Asymptomatic patients with chronic stable radiographic changes allowed * No unstable or uncompensated respiratory disease Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 12 months after completion of study treatment * Able to swallow and retain oral medication * No active infection * No uncontrolled diabetes mellitus * No history of allergic reactions or hypersensitivity attributed to compounds of similar chemical or biological composition to study drugs * No other severe or uncontrolled systemic disease * No other serious underlying medical condition that would preclude study participation * No psychiatric disability that would preclude study compliance or giving informed consent * No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Prior intrapleural or intrapericardial local chemotherapy allowed * No prior chemotherapy for advanced disease * More than 6 months since prior neoadjuvant or adjuvant systemic chemotherapy for NSCLC Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * Concurrent palliative radiotherapy allowed (except to brain metastases) Surgery * Not specified Other * No prior epidermal growth factor receptor-targeted therapy for NSCLC * No concurrent use of any of the following CYP3A4 inducers: * Phenytoin * Carbamazepine * Rifampin * Barbiturates * Hypericum perforatum (St. John's wort) * More than 30 days since prior participation in another clinical trial * No other concurrent investigational agent

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

Sponsors & Collaborators

• Swiss Cancer Institute: lead

Study Sites (14)

Saint Claraspital AG

Basel, CH-4016, Switzerland

Location

Universitaetsspital-Basel

Basel, CH-4031, Switzerland

Location

Inselspital Bern

Bern, CH-3010, Switzerland

Location

Kantonsspital Bruderholz

Bruderholz, CH-4101, Switzerland

Location

Spitaeler Chur AG

Chur, CH-7000, Switzerland

Location

Hopital Cantonal Universitaire de Geneve

Geneva, CH-1211, Switzerland

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, CH-1011, Switzerland

Location

Kantonsspital

Liestal, CH-4410, Switzerland

Location

Kantonsspital - St. Gallen

Sankt Gallen, CH-9007, Switzerland

Location

Regionalspital

Thun, 3600, Switzerland

Location

Kantonsspital Winterthur

Winterthur, CH-8400, Switzerland

Location

City Hospital Triemli

Zurich, 8063, Switzerland

Location

Klinik Hirslanden

Zurich, CH-8008, Switzerland

Location

UniversitaetsSpital Zuerich

Zurich, CH-8091, Switzerland

Location

Related Publications (1)

• D'Addario G, Rauch D, Stupp R, Pless M, Stahel R, Mach N, Jost L, Widmer L, Tapia C, Bihl M, Mayer M, Ribi K, Lerch S, Bubendorf L, Betticher DC. Multicenter phase II trial of gefitinib first-line therapy followed by chemotherapy in advanced non-small-cell lung cancer (NSCLC): SAKK protocol 19/03. Ann Oncol. 2008 Apr;19(4):739-45. doi: 10.1093/annonc/mdm564. Epub 2007 Dec 19.

  PMID: 18096565 RESULT

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma of Lung

Interventions

Cisplatin; Gefitinib; Gemcitabine

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

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

Study Officials

• Daniel C. Betticher, MD

  Insel Gruppe AG, University Hospital Bern

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2005
• First Posted: September 22, 2005
• Study Start: November 1, 2003
• Primary Completion: October 1, 2004
• Study Completion: October 1, 2004
• Last Updated: June 5, 2012

Record last verified: 2012-06

Locations

CH (14)