Docetaxel & Oxaliplatin in Combination With Bevacizumab as First-Line Treatment in Subjects With Non-Small Cell Lung Cancer (NSCLC)
The purpose of this study was to see how well three investigational drugs worked together in preventing progression of the disease. This study provided a new combination of chemotherapy drugs - docetaxel and oxaliplatin - as first line therapy in the treatment of lung cancer. The therapy included bevacizumab that may prevent or slow down the blood supply to the tumor and may also prevent tumor growth. The three investigational drugs are United States Food and Drug Administration (FDA) approved.
Non-Small Cell Lung Cancer
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Multicenter Study of Docetaxel and Oxaliplatin in Combination With Bevacizumab as First-Line Treatment in Chemotherapy-Naïve Subjects With Unresectable Locally Advanced and/or Recurrent (Stage IIIB) or Metastatic (Stage IV) Non-Squamous Cell Histology Non-Small Cell Lung Cancer (NSCLC)|
- Progression-free Survival (PFS) [ Time Frame: Baseline to PFS (up to 24 months after the first treatment) ] [ Designated as safety issue: No ]
PFS was defined as the interval from the date of registration to the earliest date of documented evidence of progressive disease, or the date of death due to any cause, whichever occurred first.
Progressive disease occurred when the participant had at least a 20% increase in the sum of the longest diameter (LD) of target lesions, compared to the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions.
- Objective Response Rate [ Time Frame: Baseline to CR or PR (up to 24 months after the first treatment) ] [ Designated as safety issue: No ]
Objective response rate is the percentage of participants with an objective response. Improvements in tumor measurements from baseline values were assigned a status of Complete Response (CR) or Partial response (PR) based on the Response Evaluation Criteria in Solid Tumors (RECIST). Overall objective response was the sum of CR and PR.
CR referred to the disappearance of all target lesions, and PR was at least 30% decrease in the sum of the longest diameter (LD) of target lesions, compared to the baseline sum LD. Responses were confirmed by repeat assessments within 4 to 6 weeks.
- Time-to-treatment Failure (TTF) [ Time Frame: Baseline to treatment failure (up to 24 months after the first treatment) ] [ Designated as safety issue: No ]
Treatment failure was defined as an event which lead to the participant's withdrawal from the study treatment due to lack of efficacy, disease progression, adverse events, or due to a participant's request as recorded in the Case Report Form (CRF), death, or use of other anticancer therapy.
TTF was assessed using Kaplan-Meier method, and the median TTF with 95% CIs was computed using the Brookmeyer and Crowley method.
- Overall Survival (OS) [ Time Frame: Baseline to OS (up to 24 months after the first treatment) ] [ Designated as safety issue: No ]OS was measured from the date of registration to the date of death due to any cause, or to the date of last contact (for censored observations). OS was assessed by the Kaplan-Meier method and the estimates of median survival time with 95% CI are reported.
- Number of Participants With Treatment-related Toxicities [ Time Frame: From baseline up to 30 days after treatment discontinuation ] [ Designated as safety issue: Yes ]
Treatment-related toxicities were serious and non-serious adverse events (AE) considered related to study treatment by the investigator.
AEs were any unfavorable and unintended signs, symptoms, syndromes, or illnesses that developed or worsened during the observation period, and included abnormal results from diagnostic procedures. Serious AEs resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability or incapacity, appeared as a congenital anomaly or were considered medically important by the investigator.
|Study Start Date:||July 2006|
|Study Completion Date:||August 2010|
|Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
Participants with advanced, recurrent, or metastatic Non Small Cell Lung Cancer (NSCLC), treated with the combination of docetaxel, followed by oxaliplatin, and then bevacizumab for Cycles 1-6 (every 3 weeks), and followed with maintenance therapy with bevacizumab every 3 weeks for a total of 52 weeks.
70 mg/m^2 administered intravenously (IV) on Day 1 for Cycles 1-6 (the treatment cycle is 3 weeks)Drug: Oxaliplatin
100 mg/m^2 administered IV on Day 1 for Cycles 1-6Drug: Bevacizumab
15 mg/kg administered IV on Day 1 for Cycles 1-6, and every 3 weeks during maintenance therapy for a total treatment of one year, until disease progression or death due to any cause, whichever occurs first.
The planned treatment duration for each participant is six 21-day treatment cycles of combination therapy; non-progressing participants will continue on bevacizumab monotherapy until progression. After discontinuation or after completion of all study treatments, all participants will be contacted every 3 months for a maximum of 2 years from first treatment to document overall survival and record new anticancer treatment (chemotherapy or biologic).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00356122
|United States, New Jersey|
|Sanofi-Aventis Administrative Office|
|Bridgewater, New Jersey, United States, 08807|
|Study Director:||Vicki Erickson, MSN||Sanofi|