Docetaxel & Oxaliplatin in Combination With Bevacizumab as First-Line Treatment in Subjects With Non-Small Cell Lung Cancer (NSCLC)

Phase 2

Completed

Conditions: Non-Small Cell Lung Cancer

Interventions: Drug: Docetaxel
Drug: Oxaliplatin
Drug: Bevacizumab

Registration Number: NCT00356122

Lead Sponsor: Sanofi

Brief Summary: 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.

Detailed Description: 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).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 53

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Docetaxel/Oxaliplatin/Bevacizumab	Oxaliplatin	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.
Docetaxel/Oxaliplatin/Bevacizumab	Docetaxel	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.
Docetaxel/Oxaliplatin/Bevacizumab	Bevacizumab	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.

Primary Outcome Measures

Name	Time	Method
Progression-free Survival (PFS)	Baseline to PFS (up to 24 months after the first treatment)	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.

Secondary Outcome Measures

Name	Time	Method
Time-to-treatment Failure (TTF)	Baseline to treatment failure (up to 24 months after the first treatment)	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.
Objective Response Rate	Baseline to CR or PR (up to 24 months after the first treatment)	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.
Overall Survival (OS)	Baseline to OS (up to 24 months after the first treatment)	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	From baseline up to 30 days after treatment discontinuation	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.