A Study of Pemetrexed and Bevacizumab for Participants With Advanced Non-Small Cell Cancer

Sponsor
Eli Lilly and Company
Study ID
NCT01004250
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Pemetrexed — DRUG
    500 milligram per square meter (mg/m²) given intravenously on Day 1 of each 21-day cycle for four cycles of Induction Therapy, and continued in Maintenance Therapy until progression or unacceptable toxicity.
  • Cisplatin — DRUG
    75 mg/m² given intravenously on Day 1 of 21-day cycle for a maximum of 4 cycles
  • Bevacizumab — DRUG
    7.5 milligram per kilogram (mg/kg) given intravenously on Day 1 of 21-day cycle for four cycles of Induction Therapy, and continued in Maintenance Therapy until progression or unacceptable toxicity

Study Details

Participants with advanced non-small cell lung cancer (NSCLC) will receive a first-line treatment of Pemetrexed, Cisplatin and Bevacizumab as induction therapy followed by a maintenance treatment of Pemetrexed and Bevacizumab. Treatment will continue until disease progression or unacceptable toxicity occurs. The primary objective of this study is to measure how long this treatment could prevent the disease progression.

Key Dates

First listed
Oct 29, 2009
Start date
Oct 31, 2009
Status verified
Apr 2014
Primary completion
Nov 30, 2012
Completion
Dec 31, 2013

Study Design

Enrollment
109 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Study Treatment

Primary Outcome Measure

Progression-Free Survival [ Time Frame: From enrollment to the first date of objectively determined Progressive Disease (PD) or death from any cause (every other cycle during study treatment and then every 6 weeks during follow-up period)(Baseline up to 36.1 Months) ]

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