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

Sponsor
National Cancer Institute, Naples
Study ID
NCT00401492
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
70 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • gemcitabine prolonged continuous infusion — DRUG
  • cisplatin — DRUG
  • vinorelbine — DRUG

Study Details

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

Key Dates

Start date
Jun 30, 2002
Status verified
Jul 2012
Primary completion
Dec 31, 2006
Completion
Apr 30, 2007

Study Design

Enrollment
159 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Primary Outcome Measure

Activity and toxicity of monochemotherapy with gemcitabine as prolonged infusion

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