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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute, Naples
ClinicalTrials.gov Identifier:
NCT00401492
First received: November 17, 2006
Last updated: July 12, 2012
Last verified: July 2012
  Purpose

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.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00401492

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

Publications:
Responsible Party: National Cancer Institute, Naples
ClinicalTrials.gov 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:
elderly
chemotherapy
quality of life
ADL
toxicity

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

ClinicalTrials.gov processed this record on September 16, 2014