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MILES-02: Study of Chemotherapy Treatment and Toxicity in Elderly Patients With Advanced Non Small Cell Lung Cancer

Primary Purpose

Non Small Cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
gemcitabine prolonged continuous infusion
cisplatin
vinorelbine
Sponsored by
National Cancer Institute, Naples
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring elderly, chemotherapy, quality of life, ADL, toxicity

Eligibility Criteria

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

Inclusion Criteria:

  • Histologic or cytologic diagnosis of NSCLC
  • Stage IV or IIIB with pleural effusion or metastatic supraclavicular lymphoadenopathy
  • Age > o = 70 years.
  • Written informed consent.

Exclusion Criteria:

  • Performance status (ECOG) ³2
  • Previous chemotherapy.
  • Symptomatic brain metastases requiring synchronous radiotherapy
  • Previous radiotherapy (completed less than 4 weeks before enrollment)
  • Previous or synchronous malignant disease (except adequately treated non melanomatous skin cancer or carcinoma in situ of the cervix) if diagnosed in the last five years before enrollment.
  • Neutrophils < 2.000/mm³ or platelets < 100.000/mm³ or hemoglobin < 10 g/dl.
  • Serum creatinine > 1.5 times the UNL.
  • GOT and/or GPT >1.25 times the UNL or serum total bilirubin >1.25 times the UNL without hepatic metastases.
  • GOT and/or GPT >2.5 times the UNL or serum total bilirubin >1.5 times the UNL with hepatic metastases.
  • Other concomitant diseases contraindicating the study treatments.
  • Refusal of written informed consent.
  • Follow-up impossible.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Activity and toxicity of monochemotherapy with gemcitabine as prolonged infusion
    Toxicity and activity of 2 standard polychemotherapy cisplatin based treatments (cisplatin and vinorelbine , and cisplatin and gemcitabine

    Secondary Outcome Measures

    patient quality of life
    the prognostic significance of the ADL and IADL scales for time to progression and survival
    exploratory predictive clinical variables for chemotherapy related toxicity
    exploratory predictive clinical variables for response to chemotherapy

    Full Information

    First Posted
    November 17, 2006
    Last Updated
    July 12, 2012
    Sponsor
    National Cancer Institute, Naples
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00401492
    Brief Title
    MILES-02: Study of Chemotherapy Treatment and Toxicity in Elderly Patients With Advanced Non Small Cell Lung Cancer
    Official Title
    Phase II Study of Chemotherapy With Gemcitabine in Prolonged Infusion or With Schedules With Cisplatin in Non-small Cell Lung Cancer Elderly Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2002 (undefined)
    Primary Completion Date
    December 2006 (Actual)
    Study Completion Date
    April 2007 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    National Cancer Institute, Naples

    4. Oversight

    5. Study Description

    Brief Summary
    The main purpose of this study is to describe activity and toxicity of single-agent gemcitabine given as prolonged infusion, and of two 2-drug combinations containing cisplatin (cisplatin + vinorelbine, and cisplatin + gemcitabine) in the treatment of elderly patients with advanced non small cell lung cancer
    Detailed Description
    The study design includes three parallel phase II studies, all with the same rules for patient selection and outcome assessment. In the two studies of cisplatin-based doublets, a dose-finding phase is planned, with subsequent cohorts of 6 patients treated with increasing doses of cisplatin (50-60-70 mg/m²). Following this phase, patients will be assigned to the three studies through a randomization procedure, to reduce selection biases. Arm A: gemcitabine: Gemcitabine 1200 mg/m2 intravenously in 2 hours (10 mg/m²/minute) on days 1 & 8 of each cycle, every 21 days, for a maximum of 6 cycles. Arm B: cisplatin + vinorelbine: Vinorelbine 25 mg/m² on days 1 & 8, followed by Cisplatin (50 or 60 or 70 mg/m²) on day 1 of each cycle, every 21 days, for a maximum of 6 cycles. Arm C: cisplatin + gemcitabine: Gemcitabine 1000 mg/m2,, on days 1 & 8, followed by Cisplatin (50 or 60 or 70 mg/m²) on day 1 of each cycle, every 21 days, for a maximum of 6 cycles.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Non Small Cell Lung Cancer
    Keywords
    elderly, chemotherapy, quality of life, ADL, toxicity

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    159 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    gemcitabine prolonged continuous infusion
    Intervention Type
    Drug
    Intervention Name(s)
    cisplatin
    Intervention Type
    Drug
    Intervention Name(s)
    vinorelbine
    Primary Outcome Measure Information:
    Title
    Activity and toxicity of monochemotherapy with gemcitabine as prolonged infusion
    Title
    Toxicity and activity of 2 standard polychemotherapy cisplatin based treatments (cisplatin and vinorelbine , and cisplatin and gemcitabine
    Secondary Outcome Measure Information:
    Title
    patient quality of life
    Title
    the prognostic significance of the ADL and IADL scales for time to progression and survival
    Title
    exploratory predictive clinical variables for chemotherapy related toxicity
    Title
    exploratory predictive clinical variables for response to chemotherapy

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Histologic or cytologic diagnosis of NSCLC Stage IV or IIIB with pleural effusion or metastatic supraclavicular lymphoadenopathy Age > o = 70 years. Written informed consent. Exclusion Criteria: Performance status (ECOG) ³2 Previous chemotherapy. Symptomatic brain metastases requiring synchronous radiotherapy Previous radiotherapy (completed less than 4 weeks before enrollment) Previous or synchronous malignant disease (except adequately treated non melanomatous skin cancer or carcinoma in situ of the cervix) if diagnosed in the last five years before enrollment. Neutrophils < 2.000/mm³ or platelets < 100.000/mm³ or hemoglobin < 10 g/dl. Serum creatinine > 1.5 times the UNL. GOT and/or GPT >1.25 times the UNL or serum total bilirubin >1.25 times the UNL without hepatic metastases. GOT and/or GPT >2.5 times the UNL or serum total bilirubin >1.5 times the UNL with hepatic metastases. Other concomitant diseases contraindicating the study treatments. Refusal of written informed consent. Follow-up impossible.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Cesare Gridelli, M.D.
    Organizational Affiliation
    San Giuseppe Moscati Hospital
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Francesco Perrone, M.D.
    Organizational Affiliation
    National Cancer Institute, Naples Italy
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17925563
    Citation
    Gridelli C, Maione P, Illiano A, Piantedosi FV, Favaretto A, Bearz A, Robbiati SF, Filipazzi V, Lorusso V, Carrozza F, Iaffaioli RV, Manzione L, Gallo C, Morabito A, Perrone F. Cisplatin plus gemcitabine or vinorelbine for elderly patients with advanced non small-cell lung cancer: the MILES-2P studies. J Clin Oncol. 2007 Oct 10;25(29):4663-9. doi: 10.1200/JCO.2007.12.5708.
    Results Reference
    result
    PubMed Identifier
    18683299
    Citation
    Gridelli C, De Maio E, Barbera S, Sannicolo M, Piazza E, Piantedosi F, Brancaccio L, Morabito A, Maione P, Renda F, Signoriello G, Perrone F; MILES Investigators. The MILES-2G phase 2 study of single-agent gemcitabine with prolonged constant infusion in advanced non-small cell lung cancer elderly patients. Lung Cancer. 2008 Jul;61(1):67-72. doi: 10.1016/j.lungcan.2007.12.002.
    Results Reference
    result

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    MILES-02: Study of Chemotherapy Treatment and Toxicity in Elderly Patients With Advanced Non Small Cell Lung Cancer

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