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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
cisplatin
gefitinib
gemcitabine hydrochloride
Sponsored by
Swiss Group for Clinical Cancer Research
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Saint Claraspital AG
  • Universitaetsspital-Basel
  • Inselspital Bern
  • Kantonsspital Bruderholz
  • Spitaeler Chur AG
  • Hopital Cantonal Universitaire de Geneve
  • Centre Hospitalier Universitaire Vaudois
  • Kantonsspital
  • Kantonsspital - St. Gallen
  • Regionalspital
  • Kantonsspital Winterthur
  • City Hospital Triemli
  • Klinik Hirslanden
  • UniversitaetsSpital Zuerich

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 20, 2005
Last Updated
June 2, 2012
Sponsor
Swiss Group for Clinical Cancer Research
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1. Study Identification

Unique Protocol Identification Number
NCT00217698
Brief Title
Gefitinib as First-Line Therapy Followed by Gemcitabine and Cisplatin in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
Official Title
Multicenter Phase II Trial of Gefitinib (Iressa™) First Line Therapy Followed by Chemotherapy in Advanced Non-Small Cell Lung Cancer (NSCLC)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
October 2004 (Actual)
Study Completion Date
October 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swiss Group for Clinical Cancer Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
OBJECTIVES: Primary Determine the efficacy of gefitinib as first-line therapy, in terms of response rate (complete and partial response) or stability of disease, in patients with de novo or recurrent stage IIIB or IV non-small cell lung cancer. Secondary Determine the safety of this drug in these patients. Determine the efficacy of gemcitabine combined with cisplatin when administered after first-line gefitinib in these patients. Determine quality of life of patients treated with this regimen. OUTLINE: This is an open-label, multicenter study. Patients receive oral gefitinib once daily until disease progression or unacceptable toxicity. Within 3 weeks after documented disease progression, patients receive gemcitabine IV over 30 minutes on days 1 and 8 followed by cisplatin IV over 1 hour on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, weeks 3, 6, 12, 18, and then every 12 weeks thereafter during gefitinib treatment. During chemotherapy, quality of life is assessed 1 week prior to starting chemotherapy treatment, day 1 of courses 3 and 5, and then every 12 weeks until disease progression. After completion of study therapy, patients are followed every 3 months. PROJECTED ACCRUAL: 'A total of 24-63 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
gefitinib
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Primary Outcome Measure Information:
Title
Disease stabilization (complete response [CR], partial response [PR], or stable disease [SD]) after 12 weeks of study treatment
Secondary Outcome Measure Information:
Title
Disease stabilization (CR, PR, or SD) after 6 and 18 weeks of study treatment
Title
Objective response (CR and PR) to gefitinib treatment after weeks 6, 12, and 18
Title
Adverse reactions to gefitinib treatment measured after completion of study treatment
Title
Time to progression (TTP) with gefitinib treatment after completion of study treatment
Title
Event-free survival (EFS) with gefitinib treatment after completion of study treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel C. Betticher, MD
Organizational Affiliation
Insel Gruppe AG, University Hospital Bern
Official's Role
Study Chair
Facility Information:
Facility Name
Saint Claraspital AG
City
Basel
ZIP/Postal Code
CH-4016
Country
Switzerland
Facility Name
Universitaetsspital-Basel
City
Basel
ZIP/Postal Code
CH-4031
Country
Switzerland
Facility Name
Inselspital Bern
City
Bern
ZIP/Postal Code
CH-3010
Country
Switzerland
Facility Name
Kantonsspital Bruderholz
City
Bruderholz
ZIP/Postal Code
CH-4101
Country
Switzerland
Facility Name
Spitaeler Chur AG
City
Chur
ZIP/Postal Code
CH-7000
Country
Switzerland
Facility Name
Hopital Cantonal Universitaire de Geneve
City
Geneva
ZIP/Postal Code
CH-1211
Country
Switzerland
Facility Name
Centre Hospitalier Universitaire Vaudois
City
Lausanne
ZIP/Postal Code
CH-1011
Country
Switzerland
Facility Name
Kantonsspital
City
Liestal
ZIP/Postal Code
CH-4410
Country
Switzerland
Facility Name
Kantonsspital - St. Gallen
City
St. Gallen
ZIP/Postal Code
CH-9007
Country
Switzerland
Facility Name
Regionalspital
City
Thun
ZIP/Postal Code
3600
Country
Switzerland
Facility Name
Kantonsspital Winterthur
City
Winterthur
ZIP/Postal Code
CH-8400
Country
Switzerland
Facility Name
City Hospital Triemli
City
Zurich
ZIP/Postal Code
8063
Country
Switzerland
Facility Name
Klinik Hirslanden
City
Zurich
ZIP/Postal Code
CH-8008
Country
Switzerland
Facility Name
UniversitaetsSpital Zuerich
City
Zurich
ZIP/Postal Code
CH-8091
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
18096565
Citation
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.
Results Reference
result

Learn more about this trial

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

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