Trial Outcomes & Findings for Biweekly Schedule of Docetaxel and Cisplatin in High Risk Patients With Unresectable Non-small Cell Lung Cancer (NSCLC) (NCT NCT00995761)

Results Overview

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. During treatment, a limited history, physical examination, assessment of toxicity, CBC with differentials, and blood chemistry tests were repeated weekly. A chest X-ray was performed every 2 weeks before each cycle. Appropriate imaging studies, including CT scans of the chest and upper abdomen, were performed every two cycles to assess the treatment response, and sooner, if required, to document disease progression. Objective tumor responses were assessed according to the RECIST criteria V 1.0.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

48 participants

Primary outcome timeframe

after every 2 cycles of docetaxel and cisplatin

Results posted on

2014-03-03

Participant Flow

anticipated dates of final recruitment: September 2011 Type of location: University Hospital Clinic

not specific problems

Participant milestones

Participant milestones
Measure	Biweekly Schedule docetaxel 40mg/m2 on day 1,15 every 4weeks cisplatin 40mg/m2 on day 1,15 every 4weeks
Overall Study STARTED	48
Overall Study COMPLETED	48
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Biweekly Schedule of Docetaxel and Cisplatin in High Risk Patients With Unresectable Non-small Cell Lung Cancer (NSCLC)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Biweekly Schedule n=48 Participants docetaxel 40mg/m2 on day 1,15 every 4weeks cisplatin 40mg/m2 on day 1,15 every 4weeks
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=5 Participants
Age, Categorical >=65 years	25 Participants n=5 Participants
Age, Continuous	66 years INTER_QUARTILE_RANGE 1.5 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	43 Participants n=5 Participants
Region of Enrollment Korea, Republic of	48 participants n=5 Participants

PRIMARY outcome

Timeframe: after every 2 cycles of docetaxel and cisplatin

Population: The sample size was calculated according to Simon's two-stage optimal design.The statistical evaluation was performed based on an ITT analysis. Descriptive statistics are reported as proportions and medians. OS and TTP were assessed by the K-M method, and the 95% CI for the median time to events was computed.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. During treatment, a limited history, physical examination, assessment of toxicity, CBC with differentials, and blood chemistry tests were repeated weekly. A chest X-ray was performed every 2 weeks before each cycle. Appropriate imaging studies, including CT scans of the chest and upper abdomen, were performed every two cycles to assess the treatment response, and sooner, if required, to document disease progression. Objective tumor responses were assessed according to the RECIST criteria V 1.0.

Outcome measures

Outcome measures
Measure	Biweekly Schedule of Docetaxel and Cisplatin n=48 Participants we conducted the present phase II study to investigate the efficacy and safety of a biweekly schedule of docetaxel and cisplatin in patients with unresectable NSCLC.
Response Rates Confirmed With CT or MRI	64.6 percentage of participants Interval 52.1 to 77.1

PRIMARY outcome

Timeframe: after every 2 cycles of docetaxel and cisplatin

we conducted the present phase II study to investigate the efficacy and safety of a biweekly schedule of docetaxel and cisplatin in patients with unresectable NSCLC (OS, TTP, and Others)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From date of enrollment in this study until the date of first documented progression or date of death from any cause, whichever came first, after every 2 cycles of docetaxel and cisplatin

Outcome measures

Outcome data not reported

Adverse Events

Biweekly Schedule

Serious events: 7 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Biweekly Schedule n=48 participants at risk docetaxel 40mg/m2 on day 1,15 every 4weeks cisplatin 40mg/m2 on day 1,15 every 4weeks
Gastrointestinal disorders Diarrhea	10.4% 5/48 • Number of events 5
Blood and lymphatic system disorders neutropenia	6.2% 3/48 • Number of events 3
Blood and lymphatic system disorders leukopenia	8.3% 4/48 • Number of events 4
Infections and infestations Infection	10.4% 5/48 • Number of events 5
Musculoskeletal and connective tissue disorders Asthenia	6.2% 3/48 • Number of events 3
Blood and lymphatic system disorders anemia	14.6% 7/48 • Number of events 7

Other adverse events

Adverse event data not reported

Additional Information

Gyeong-Won Lee M.D.Ph.D.

Gyeongsang National University Hospital

Phone: 82-55-750-8066

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place