A Study of Avastin (Bevacizumab) in Combination With Platinum-Based Chemotherapy in Patients With Advanced or Recurrent Squamous Non-Small Cell Lung Cancer

Sponsor
Hoffmann-La Roche
Study ID
NCT00404703
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • bevacizumab [Avastin] — DRUG
    15mg iv on day 1 of each 3 week cycle
  • Platinum-based chemotherapy — DRUG
    As prescribed

Study Details

This single arm study will assess the feasibility of using Avastin plus platinum-based chemotherapy (cisplatin-gemcitabine or carboplatin-paclitaxel) in patients with advanced or recurrent squamous non-small cell lung cancer who have not received prior chemotherapy. Patients will receive preventive radiation, followed by one cycle of chemotherapy alone and 5 cycles of chemotherapy in combination with Avastin (15mg/kg iv on day 1 of each 3 weekly cycle), followed by Avastin alone for a maximum total treatment period with Avastin of 12 months. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

Key Dates

First listed
Nov 29, 2006
Start date
Aug 31, 2006
Status verified
Aug 2008
Primary completion
Feb 29, 2008
Completion
Feb 29, 2008

Study Design

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

Arms

  • Experimental: 1

Primary Outcome Measure

Rate of grade >=3 Avastin-related pulmonary hemorrhage [ Time Frame: After a maximum of 12 months treatment ]

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