A Study of Avastin (Bevacizumab) in Combination With Docetaxel and Cisplatin in Patients With Metastatic or Locally Advanced Non-small Cell Lung Cancer

Sponsor
Hoffmann-La Roche
Study ID
NCT00661778
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Bevacizumab — DRUG
    Bevacizumab was supplied as a sterile liquid in glass vials.
  • Cisplatin — DRUG
    Bevacizumab was supplied as a sterile liquid in glass vials.
  • Docetaxel — DRUG
    Bevacizumab was supplied as a sterile liquid in glass vials.

Study Details

This study assessed the efficacy and safety of Avastin in combination with docetaxel and cisplatin as first-line treatment of patients with metastatic or locally advanced non-small cell lung cancer. Patients received Avastin 15 mg/kg intravenously (IV), docetaxel 75 mg/m\^2, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle for a maximum of 6 cycles.

Key Dates

First listed
Apr 18, 2008
Start date
Jul 31, 2007
Status verified
Jul 2014
Primary completion
Jul 31, 2011
Completion
Jul 31, 2011

Study Design

Enrollment
50 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Bevacizumab + cisplatin + docetaxel
    Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m\^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent.

Primary Outcome Measure

Progression-free Survival [ Time Frame: Baseline to the end of the study (up to 4 years) ]

Related Studies