Statement: the primary trial measures the overall quality of life of its cohorts, while the secondary trial assesses the duration of stable disease
Primary_evidence: Outcome Measurement:    Percentage of Participants With Objective Response (OR; Using Response Evaluation Criteria in Solid Tumors [RECIST])   The participant had an OR if her best overall response (BOR) during the study was either a complete response (CR) or a partial response (PR) according to the RECIST as determined by the investigator. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (LD) of all target lesions. Confidence interval (CI) was Computed using Clopper-Pearson method.   Time frame: Assessed every 6 weeks for first 12 months from randomization thereafter every 3 months until disease progression (maximum participant objective response of 18.3 weeks) Results 1:    Arm/Group Title: Ixabepilone 40 mg/m^2   Arm/Group Description: ixabepilone 40 mg/m^2 every 3 weeks   Overall Number of Participants Analyzed: 40   Measure Type: Number   Unit of Measure: percentage of participants  30.0        (16.6 to 46.5) Results 2:    Arm/Group Title: Cetuximab 250 mg/m^2 + Ixabepilone 40 mg/m^2   Arm/Group Description: cetuximab 400 mg/m^2 loading dose then 250 mg/m^2 weekly + ixabepilone 40 mg/m^2 every 3 weeks   Overall Number of Participants Analyzed: 39   Measure Type: Number   Unit of Measure: percentage of participants  35.9        (21.2 to 52.8)
Secondary_evidence: Outcome Measurement:    Progression Free Survival   PFS is defined as the period from the day of randomization until the first observation of lesion progression or death from any cause. Disease progression is defined as PD according to RECIST Ver. 1.1.   Assessment period was from the day of randomisation until the first observation of lesion progression or death   Time frame: Baseline, every 6 weeks of study treatment period, and end of study, Results 1:    Arm/Group Title: NK105   Arm/Group Description: received NK105 (65 mg/m^2) on days 1, 8 and 15 of a 28-day cycle   Overall Number of Participants Analyzed: 211   Median (95% Confidence Interval)   Unit of Measure: months  8.4        (7.0 to 9.9) Results 2:    Arm/Group Title: Paclitaxel   Arm/Group Description: received Paclitaxel (80 mg/m^2) on days 1, 8 and 15 of a 28-day cycle   Overall Number of Participants Analyzed: 211   Median (95% Confidence Interval)   Unit of Measure: months  8.5        (6.9 to 11.5)