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

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. Identifier: NCT00401492
Recruitment Status : Completed
First Posted : November 20, 2006
Last Update Posted : July 13, 2012
Information provided by (Responsible Party):
National Cancer Institute, Naples

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

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Drug: gemcitabine prolonged continuous infusion Drug: cisplatin Drug: vinorelbine Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 159 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2002
Actual Primary Completion Date : December 2006
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Primary Outcome Measures :
  1. Activity and toxicity of monochemotherapy with gemcitabine as prolonged infusion
  2. Toxicity and activity of 2 standard polychemotherapy cisplatin based treatments (cisplatin and vinorelbine , and cisplatin and gemcitabine

Secondary Outcome Measures :
  1. patient quality of life
  2. the prognostic significance of the ADL and IADL scales for time to progression and survival
  3. exploratory predictive clinical variables for chemotherapy related toxicity
  4. exploratory predictive clinical variables for response to chemotherapy

Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT00401492

Sponsors and Collaborators
National Cancer Institute, Naples
Principal Investigator: Cesare Gridelli, M.D. San Giuseppe Moscati Hospital
Principal Investigator: Francesco Perrone, M.D. National Cancer Institute, Naples Italy

Publications of Results:
Responsible Party: National Cancer Institute, Naples Identifier: NCT00401492     History of Changes
Other Study ID Numbers: MILES-02
First Posted: November 20, 2006    Key Record Dates
Last Update Posted: July 13, 2012
Last Verified: July 2012

Keywords provided by National Cancer Institute, Naples:
quality of life

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic