Trial Outcomes & Findings for A Phase II Study of Capecitabine and Docetaxel in Previously Untreated Advanced Non-Small Cell Lung Cancer Patients (NCT NCT00201825)

NCT ID: NCT00201825

Last Updated: 2014-10-06

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

29 participants

Primary outcome timeframe

Every 35 days

Results posted on

2014-10-06

Participant Flow

Patients were enrolled and received treatment between December 2004 and November 2007

Participant milestones

Participant milestones
Measure	Docetaxel and Capecitabine Capecitabine: 1250 mg/m2/day in 2 oral daily divided doses of 625 mg/m2 on day 5 of every cycle and continued for 14 days. Docetaxel: 36 mg/m2 IV weekly for 3 weeks every 4 weeks.
Overall Study STARTED	29
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Phase II Study of Capecitabine and Docetaxel in Previously Untreated Advanced Non-Small Cell Lung Cancer Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Docetaxel and Capecitabine n=29 Participants Capecitabine: 1250 mg/m2/day in 2 oral daily divided doses of 625 mg/m2 on day 5 of every cycle and continued for 14 days. Docetaxel: 36 mg/m2 IV weekly for 3 weeks every 4 weeks.
Age, Continuous	61 years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	25 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	29 patients n=5 Participants
Histology Adenocarcinoma	13 patients n=5 Participants
Histology Squamous cell carcinoma	6 patients n=5 Participants
Histology Large cell Carcinoma	2 patients n=5 Participants
Histology NSCLC not specified	8 patients n=5 Participants
ECOG (Eastern Cooperative Oncology Group) Performance status 0 (Fully active)	8 patients n=5 Participants
ECOG (Eastern Cooperative Oncology Group) Performance status 1 (Restricted activity)	21 patients n=5 Participants

PRIMARY outcome

Timeframe: Every 35 days

Population: One patient was not evaluable for response because the patient was removed from study afer an adverse event.

Outcome measures

Outcome measures
Measure	Docetaxel and Capecitabine n=28 Participants Capecitabine: 1250 mg/m2/day in 2 oral daily divided doses of 625 mg/m2 on day 5 of every cycle and continued for 14 days. Docetaxel: 36 mg/m2 IV weekly for 3 weeks every 4 weeks.
Determine Objective Response Rate Complete response (CR)	0 patients
Determine Objective Response Rate Partial response (PR)	5 patients
Determine Objective Response Rate Stable Disease	14 patients
Determine Objective Response Rate Disease Progression	9 patients
Determine Objective Response Rate Overall response (CR + PR)	5 patients

SECONDARY outcome

Timeframe: Every 35 days

Outcome measures

Outcome measures
Measure	Docetaxel and Capecitabine n=28 Participants Capecitabine: 1250 mg/m2/day in 2 oral daily divided doses of 625 mg/m2 on day 5 of every cycle and continued for 14 days. Docetaxel: 36 mg/m2 IV weekly for 3 weeks every 4 weeks.
Time to Tumor Progression	3.3 months Interval 1.5 to 4.6

SECONDARY outcome

Timeframe: one year

Outcome measures

Outcome measures
Measure	Docetaxel and Capecitabine n=28 Participants Capecitabine: 1250 mg/m2/day in 2 oral daily divided doses of 625 mg/m2 on day 5 of every cycle and continued for 14 days. Docetaxel: 36 mg/m2 IV weekly for 3 weeks every 4 weeks.
One Year Survival	10.5 months Interval 3.2 to 15.0

SECONDARY outcome

Timeframe: Cycle 2

Population: No Pharmacokinetics were conducted for this trial.

Outcome measures

Outcome data not reported

Adverse Events

Docetaxel and Capecitabine

Serious events: 1 serious events

Other events: 29 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Docetaxel and Capecitabine n=29 participants at risk Capecitabine: 1250 mg/m2/day in 2 oral daily divided doses of 625 mg/m2 on day 5 of every cycle and continued for 14 days. Docetaxel: 36 mg/m2 IV weekly for 3 weeks every 4 weeks.
Cardiac disorders Myocardial infarction	3.4% 1/29 • Number of events 1 • Adverse events were assessed using the NCI Common Toxicity Criteria version 3.0 from week 1 of the study until end of study. Adverse events will use the descriptions and grading scales found in the revised NCI Common Toxicity Criteria (CTC). This study will utilize the CTC version 3.0 for toxicity and Adverse Drug Experience reporting.

Other adverse events

Other adverse events
Measure	Docetaxel and Capecitabine n=29 participants at risk Capecitabine: 1250 mg/m2/day in 2 oral daily divided doses of 625 mg/m2 on day 5 of every cycle and continued for 14 days. Docetaxel: 36 mg/m2 IV weekly for 3 weeks every 4 weeks.
Blood and lymphatic system disorders Anemia	51.7% 15/29 • Number of events 15 • Adverse events were assessed using the NCI Common Toxicity Criteria version 3.0 from week 1 of the study until end of study. Adverse events will use the descriptions and grading scales found in the revised NCI Common Toxicity Criteria (CTC). This study will utilize the CTC version 3.0 for toxicity and Adverse Drug Experience reporting.
General disorders Neutropenia	34.5% 10/29 • Number of events 10 • Adverse events were assessed using the NCI Common Toxicity Criteria version 3.0 from week 1 of the study until end of study. Adverse events will use the descriptions and grading scales found in the revised NCI Common Toxicity Criteria (CTC). This study will utilize the CTC version 3.0 for toxicity and Adverse Drug Experience reporting.
Investigations Leukopenia	72.4% 21/29 • Number of events 21 • Adverse events were assessed using the NCI Common Toxicity Criteria version 3.0 from week 1 of the study until end of study. Adverse events will use the descriptions and grading scales found in the revised NCI Common Toxicity Criteria (CTC). This study will utilize the CTC version 3.0 for toxicity and Adverse Drug Experience reporting.

Additional Information

Tanios Bekaii-Saab, MD

The Ohio State University Comprehensive Cancer Center

Phone: 614-293-6529

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place