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

This study has been completed.
Information provided by (Responsible Party):
National Cancer Institute, Naples Identifier:
First received: November 17, 2006
Last updated: July 12, 2012
Last verified: July 2012
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 Intervention Phase
Non Small Cell Lung Cancer
Drug: gemcitabine prolonged continuous infusion
Drug: cisplatin
Drug: vinorelbine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by National Cancer Institute, Naples:

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

Enrollment: 159
Study Start Date: June 2002
Study Completion Date: April 2007
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information

Responsible Party: National Cancer Institute, Naples Identifier: NCT00401492     History of Changes
Other Study ID Numbers: MILES-02 
Study First Received: November 17, 2006
Last Updated: July 12, 2012
Health Authority: Italy: Ethics Committee

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

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Anti-Infective Agents
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on May 26, 2016