A Study of Avastin (Bevacizumab) in Combination With Docetaxel and Cisplatin in Patients With Metastatic or Locally Advanced Non-small Cell Lung Cancer
An Open Label Study to Assess the Effect of First-line Treatment With Avastin in Combination With Docetaxel and Cisplatin on Progression-free Survival in Patients With Metastatic or Locally Advanced Non-small Cell Lung Cancer
2 other identifiers
interventional
50
1 country
14
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 nonsmall-cell-lung-cancer
Started Jul 2007
Typical duration for phase_2 nonsmall-cell-lung-cancer
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 17, 2008
CompletedFirst Posted
Study publicly available on registry
April 18, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedResults Posted
Study results publicly available
July 10, 2014
CompletedJuly 10, 2014
July 1, 2014
4 years
April 17, 2008
May 27, 2014
July 9, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-free Survival
Progression-free survival was defined as the time from enrollment in the study to the first documented disease progression using Response Evaluation Criteria In Solid Tumors (RECIST) or death from any cause, whichever occurred first.
Baseline to the end of the study (up to 4 years)
Secondary Outcomes (4)
Percentage of Participants With an Objective Response
Baseline to the end of the study (up to 4 years)
Duration of the Objective Response
Baseline to the end of the study (up to 4 years)
Overall Survival
Baseline to the end of the study (up to 4 years)
1-year Survival
Baseline to 1 year
Study Arms (1)
Bevacizumab + cisplatin + docetaxel
EXPERIMENTALParticipants 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.
Interventions
Bevacizumab was supplied as a sterile liquid in glass vials.
Bevacizumab was supplied as a sterile liquid in glass vials.
Bevacizumab was supplied as a sterile liquid in glass vials.
Eligibility Criteria
You may qualify if:
- Adult patients, ≥ 18 years of age.
- Stage IIIb or IV non-small cell lung cancer.
- Chemotherapy-naive.
You may not qualify if:
- Previous treatment for non-small cell lung cancer.
- Previous malignant tumor within last 5 years, except for basal cell skin cancer or preinvasive cervical cancer.
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to start of study.
- Recent or current chronic treatment with aspirin (\> 325 mg/day).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Unknown Facility
Palma de Mallorca, Balearic Islands, 07198, Spain
Unknown Facility
Cadiz, Cadiz, 11009, Spain
Unknown Facility
Castellon, Castellon, 12002, Spain
Unknown Facility
Donostia / San Sebastian, Guipuzcoa, 20080, Spain
Unknown Facility
Alcalá de Henares, Madrid, 28805, Spain
Unknown Facility
Madrid, Madrid, 28036, Spain
Unknown Facility
Madrid, Madrid, 28935, Spain
Unknown Facility
Málaga, Malaga, 29010, Spain
Unknown Facility
Palencia, Palencia, 34005, Spain
Unknown Facility
Sagunto, Valencia, 46520, Spain
Unknown Facility
Valencia, Valencia, 46017, Spain
Unknown Facility
Valladolid, Valladolid, 47005, Spain
Unknown Facility
Valladolid, Valladolid, 47010, Spain
Unknown Facility
Zamora, Zamora, 49021, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2008
First Posted
April 18, 2008
Study Start
July 1, 2007
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
July 10, 2014
Results First Posted
July 10, 2014
Record last verified: 2014-07