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Phase IV Study of Tarceva in Patients With Advanced Stage IIIB/ IV Non-small Cell Lung Cancer (NSCLC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01951755
Recruitment Status : Completed
First Posted : September 27, 2013
Last Update Posted : December 8, 2014
Sponsor:
Information provided by (Responsible Party):
Kostas N Syrigos, University of Athens

Brief Summary:
An open-label, non randomized clinical trial of Tarceva as single agent in progressed non-small cell lung cancer patients.

Condition or disease
Non-small Cell Lung Cancer

Detailed Description:
An observational non randomized clinical trial of Tarceva as single agent in progressed non-small cell lung cancer patients after chemotherapy.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 24 Months
Official Title: An Observational Study for Safety and Efficacy of Erlotinib Beyond 1st Line in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer
Study Start Date : January 2012
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer




Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 24 months ]
    Defined as the time period from the entry to the study until assessed disease progression or death


Secondary Outcome Measures :
  1. Safety [ Time Frame: Baseline, 4-6 months, 12 months, 24 months ]
    Adverse events and serious adverse events


Other Outcome Measures:
  1. Response Rate [ Time Frame: 4-6 months, 12 months, 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with advanced (inoperable stage IIIB or stage IV) NSCLC who had failed in platinum based chemotherapy
Criteria

Inclusion Criteria:

  • Histological or cytological documented diagnosis diagnosis of inoperable, locally advanced, recurrent or metastatic (Stage IIIB or IV) NSCLC.
  • Patients must have evidence of disease but measurable disease is not mandatory.
  • 18 years of age or older.
  • ECOG Performance Status of 0-2.
  • Life expectancy at least 12 weeks.
  • Patients with advanced stage IIIB/ IV NSCLC who have received at least one course of standard systemic chemotherapy or radiation therapy or who are in the investigator's opinion not medically suitable for chemotherapy or radiotherapy.
  • No more than 2 prior chemotherapy regimens are permissible. Patients must have recovered from any toxic effects and at least 3-4 weeks must have elapsed from the last dose and prior to registration (14 days for vinorelbine or other vinca alkaloids or gemcitabine). Patients who, in the opinion of the investigator, have fully recovered from surgery in less than 4 weeks may also be considered for the study. Patients must have recovered (CTC ≤ 1) from acute toxicities of any previous therapy.
  • Granulocyte count ≥ 1.5 x 109/L and platelet count > 100 x 109/L.
  • Serum bilirubin must be ≤ 1.5 upper limit of normal (ULN).
  • AST and/or ALT ≤ 2 x ULN (or ≤ 5 x ULN if clearly attributable to liver metastasis.
  • Serum creatinine ≤ 1.5 ULN or creatinine clearance ≥ 60 ml/min.
  • Able to comply with study and follow-up procedures.
  • For all females of childbearing potential a negative pregnancy test must be obtained within 72 hours before starting therapy.
  • Patients with reproductive potential must use effective contraception.
  • Written (signed) Informed Consent to participate in the study.

Exclusion Criteria:

  • Any unstable systemic disease (including active infection, grade 4 hypertension, unstable angina, congestive heart failure, hepatic, renal or metabolic disease).
  • Prior therapy with systemic anti-tumour therapy with HER1/EGFR inhibitors (as small molecule or monoclonal antibody therapy).
  • Any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer).
  • Patients are excluded if they have brain metastasis or spinal cord compression that is newly diagnosed and/ or has not yet been definitively treated with surgery and/ or radiation; previously diagnosed and treated CNS metastases or spinal cord compression with evidence of stable disease (clinically stable imaging) for at least 2 months is permitted.
  • Any significant ophthalmologic abnormality, especially severe dry eye syndrome, keratoconjunctivitis sicca, Sjogren syndrome, severe exposure keratitis or any other disorder likely to increase the risk of corneal epithelial lesions. The use of contact lenses is not recommended during the study. The decision to continue to wear contact lenses should be discussed with the patient's treating Oncologist and the ophthalmologist.
  • Patients who cannot take oral medication, who require intravenous alimentation, have had prior surgical procedures affecting absorption, or have active peptic ulcer disease.
  • Nursing mothers.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01951755


Locations
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Greece
Oncology Unit Sotiria Hospital of Chest Diseases
Athens, Greece, 115 27
Sponsors and Collaborators
University of Athens
Investigators
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Study Chair: KOSTAS N SYRIGOS, MD, PhD Oncology Unit University of Athens, Sotiria Hosp, 152 Mesogion Av

Additional Information:

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Responsible Party: Kostas N Syrigos, Professor in Medical Oncology, University of Athens
ClinicalTrials.gov Identifier: NCT01951755    
Other Study ID Numbers: ML27805
First Posted: September 27, 2013    Key Record Dates
Last Update Posted: December 8, 2014
Last Verified: December 2014
Keywords provided by Kostas N Syrigos, University of Athens:
Inoperable NSCLC
TKIs
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms