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

June 2, 2012 updated by: Swiss Group for Clinical Cancer Research

Multicenter Phase II Trial of Gefitinib (Iressa™) First Line Therapy Followed by Chemotherapy in Advanced Non-Small Cell Lung Cancer (NSCLC)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
63

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, CH-4016
        • Saint Claraspital AG
      • Basel, Switzerland, CH-4031
        • Universitaetsspital-Basel
      • Bern, Switzerland, CH-3010
        • Inselspital Bern
      • Bruderholz, Switzerland, CH-4101
        • Kantonsspital Bruderholz
      • Chur, Switzerland, CH-7000
        • Spitaeler Chur AG
      • Geneva, Switzerland, CH-1211
        • Hôpital Cantonal Universitaire de Genève
      • Lausanne, Switzerland, CH-1011
        • Centre hospitalier universitaire vaudois
      • Liestal, Switzerland, CH-4410
        • Kantonsspital
      • St. Gallen, Switzerland, CH-9007
        • Kantonsspital - St. Gallen
      • Thun, Switzerland, 3600
        • Regionalspital
      • Winterthur, Switzerland, CH-8400
        • Kantonsspital Winterthur
      • Zurich, Switzerland, CH-8091
        • Universitaetsspital Zuerich
      • Zurich, Switzerland, 8063
        • City Hospital Triemli
      • Zurich, Switzerland, CH-8008
        • Klinik Hirslanden

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Disease stabilization (complete response [CR], partial response [PR], or stable disease [SD]) after 12 weeks of study treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Swiss Group for Clinical Cancer Research

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Daniel C. Betticher, MD, University Hospital Inselspital, Berne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2003

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2004

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2004

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 20, 2005

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2005

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 5, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SAKK 19/03
  • EU-20519
  • ZENECA-AZ1839IL/0542 (Other Identifier: Pharmaceutical company)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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