Back to resultsA Study of Avastin (Bevacizumab) in Combination With Docetaxel and Cisplatin in Patients With Metastatic or Locally Advanced Non-small Cell Lung Cancer
Primary Purpose
Non-small Cell Lung Cancer
Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Bevacizumab
Cisplatin
Docetaxel
Sponsored by
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- Adult patients, ≥ 18 years of age.
- Stage IIIb or IV non-small cell lung cancer.
- Chemotherapy-naive.
Exclusion Criteria:
- 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).
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Bevacizumab + cisplatin + docetaxel
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Percentage of Participants With an Objective Response
An objective response was defined as a complete or partial response determined on 2 consecutive occasions ≥ 4 weeks apart using Response Evaluation Criteria in Solid Tumors (RECIST). Complete response was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must be < 10 mm on the short axis. Partial response was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum.
Duration of the Objective Response
Duration of the objective response is defined as the time from a complete or partial response to disease progression or death due to disease.
Overall Survival
Overall survival is defined as the time from the first dose of study medication until death.
1-year Survival
The probability of surviving 1 year was estimated using the Kaplan-Meier method.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00661778
Brief Title
A Study of Avastin (Bevacizumab) in Combination With Docetaxel and Cisplatin in Patients With Metastatic or Locally Advanced Non-small Cell Lung Cancer
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bevacizumab + cisplatin + docetaxel
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
Bevacizumab was supplied as a sterile liquid in glass vials.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Bevacizumab was supplied as a sterile liquid in glass vials.
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Taxotere
Intervention Description
Bevacizumab was supplied as a sterile liquid in glass vials.
Primary Outcome Measure Information:
Title
Progression-free Survival
Description
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.
Time Frame
Baseline to the end of the study (up to 4 years)
Secondary Outcome Measure Information:
Title
Percentage of Participants With an Objective Response
Description
An objective response was defined as a complete or partial response determined on 2 consecutive occasions ≥ 4 weeks apart using Response Evaluation Criteria in Solid Tumors (RECIST). Complete response was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must be < 10 mm on the short axis. Partial response was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum.
Time Frame
Baseline to the end of the study (up to 4 years)
Title
Duration of the Objective Response
Description
Duration of the objective response is defined as the time from a complete or partial response to disease progression or death due to disease.
Time Frame
Baseline to the end of the study (up to 4 years)
Title
Overall Survival
Description
Overall survival is defined as the time from the first dose of study medication until death.
Time Frame
Baseline to the end of the study (up to 4 years)
Title
1-year Survival
Description
The probability of surviving 1 year was estimated using the Kaplan-Meier method.
Time Frame
Baseline to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients, ≥ 18 years of age.
Stage IIIb or IV non-small cell lung cancer.
Chemotherapy-naive.
Exclusion Criteria:
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Cádiz
State/Province
Cadiz
ZIP/Postal Code
11009
Country
Spain
City
San Sebastian
State/Province
Guipuzcoa
ZIP/Postal Code
20080
Country
Spain
City
Palma de Mallorca
State/Province
Islas Baleares
ZIP/Postal Code
07198
Country
Spain
City
Alcala de Henares
State/Province
Madrid
ZIP/Postal Code
28805
Country
Spain
City
Sagunto
State/Province
Valencia
ZIP/Postal Code
46520
Country
Spain
City
Castellon
ZIP/Postal Code
12002
Country
Spain
City
Madrid
ZIP/Postal Code
28036
Country
Spain
City
Madrid
ZIP/Postal Code
28935
Country
Spain
City
Malaga
ZIP/Postal Code
29010
Country
Spain
City
Palencia
ZIP/Postal Code
34005
Country
Spain
City
Valencia
ZIP/Postal Code
46017
Country
Spain
City
Valladolid
ZIP/Postal Code
47005
Country
Spain
City
Valladolid
ZIP/Postal Code
47010
Country
Spain
City
Zamora
ZIP/Postal Code
49021
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
A Study of Avastin (Bevacizumab) in Combination With Docetaxel and Cisplatin in Patients With Metastatic or Locally Advanced Non-small Cell Lung Cancer
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