A Study of Avastin (Bevacizumab) in Combination With Docetaxel and Cisplatin in Patients With Metastatic or Locally Advanced Non-small Cell Lung Cancer
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- Registration Number
- NCT00661778
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- Adult patients, ≥ 18 years of age.
- Stage IIIb or IV non-small cell lung cancer.
- Chemotherapy-naive.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Bevacizumab + cisplatin + docetaxel 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. Bevacizumab + cisplatin + docetaxel Bevacizumab 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. Bevacizumab + cisplatin + docetaxel Cisplatin 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 Measures
Name Time Method Progression-free Survival Baseline to the end of the study (up to 4 years) 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
Name Time Method Percentage of Participants With an Objective Response Baseline to the end of the study (up to 4 years) 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 Baseline to the end of the study (up to 4 years) 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 Baseline to the end of the study (up to 4 years) Overall survival is defined as the time from the first dose of study medication until death.
1-year Survival Baseline to 1 year The probability of surviving 1 year was estimated using the Kaplan-Meier method.