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Status:

COMPLETED

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

Lead Sponsor:

Swiss Cancer Institute

Conditions:

Lung Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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...

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 recurr...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    November 1 2003

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    October 1 2004

    Estimated Enrollment :

    63 Patients enrolled

    Trial Details

    Trial ID

    NCT00217698

    Start Date

    November 1 2003

    End Date

    October 1 2004

    Last Update

    June 5 2012

    Active Locations (14)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 4 (14 locations)

    1

    Saint Claraspital AG

    Basel, Switzerland, CH-4016

    2

    Universitaetsspital-Basel

    Basel, Switzerland, CH-4031

    3

    Inselspital Bern

    Bern, Switzerland, CH-3010

    4

    Kantonsspital Bruderholz

    Bruderholz, Switzerland, CH-4101