Trial Outcomes & Findings for Oxaliplatin and Docetaxel as First-line Therapy for Advanced Non-small Cell Lung Cancer (NCT NCT00145418)

Last Updated: 2014-06-30

Results Overview

Response rate by RECIST criteria to the combination of oxaliplatin and docetaxel in patients with previously untreated NSCLC. Per RECIST 1.0 defines a complete response (CR)as the disappearance of all disease. A partial response(PR) as a minimum of a 30% decrease in the sum of the longest dimension of target lesions. Progressive disease (PR) is defined as a minimum of a 20% increase in the sum of the longest dimension of target lesions. Stable disease is defined as neither sufficient shrinkage to qualify as a PR nor sufficient increase to qualify as PD.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

15 participants

Primary outcome timeframe

Response is measured every 2 cycles until disease progression

Results posted on

2014-06-30

Participant Flow

patients recruited from clinical practice.

patients were screened to see if they met eligibility criteria. If criteria met, enrolled into study. Otherwise listed as screen failures.

Participant milestones

Participant milestones
Measure	Oxaliplatin + Docetaxel Oxaliplatin + Docetaxel as first line therapy of Stage IV or IIIB unresectable non-small cell lung cancer. Oxaliplatin:85 mg/m2 on Days 1 and 15 every 28 days Docetaxel:30 mg/m2 on Days 1 and 8 every 28 days.Doses will be calculated using actual body weight unless in the investigators opinion it would be in the patient's best interest to use ideal body weight. Cycles will be repeated every 28 days for a maximum of 6 cycles.
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Oxaliplatin and Docetaxel as First-line Therapy for Advanced Non-small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oxaliplatin + Docetaxel n=15 Participants Oxaliplatin + Docetaxel as first line therapy of Stage IV or IIIB unresectable non-small cell lung cancer
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants

PRIMARY outcome

Timeframe: Response is measured every 2 cycles until disease progression

Outcome measures

Outcome measures
Measure	Oxaliplatin + Docetaxel n=15 Participants Oxaliplatin + Docetaxel as first line therapy of Stage IV or IIIB unresectable non-small cell lung cancer
Response Rate partial response	7 Participants
Response Rate complete response	0 Participants
Response Rate stable disease	1 Participants

SECONDARY outcome

Timeframe: <1 cycle to 6 cycles of treatment

Progression is measured from each participants start of study until removal from treatment.

Outcome measures

Outcome measures
Measure	Oxaliplatin + Docetaxel n=15 Participants Oxaliplatin + Docetaxel as first line therapy of Stage IV or IIIB unresectable non-small cell lung cancer
Time to Progression	2.4 months Interval 0.0 to 6.0

SECONDARY outcome

Timeframe: 0 -12 months

Duration of response is a measure of how long the participants response to therapy was maintained.

Outcome measures

Outcome measures
Measure	Oxaliplatin + Docetaxel n=15 Participants Oxaliplatin + Docetaxel as first line therapy of Stage IV or IIIB unresectable non-small cell lung cancer
Duration of Response	7.9 months Interval 0.0 to 12.0

SECONDARY outcome

Timeframe: day one of cycle one until participant removed from trial

Population: all participants had adverse events

Toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE V 3.0) and the incidence of any Grade 3 or 4 toxicities will be analyzed. Toxicity is assessed every cycle.

Outcome measures

Outcome measures
Measure	Oxaliplatin + Docetaxel n=15 Participants Oxaliplatin + Docetaxel as first line therapy of Stage IV or IIIB unresectable non-small cell lung cancer
Safety Objective is to Describe the Safety Profile of 1st Line Treatment by Recording Grade 3 and 4 Adverse Events Experienced by Participants in This Trial. Grade 3 or 4 anemia	1 participants
Safety Objective is to Describe the Safety Profile of 1st Line Treatment by Recording Grade 3 and 4 Adverse Events Experienced by Participants in This Trial. grade 3 or 4 thrombocytopenia	1 participants
Safety Objective is to Describe the Safety Profile of 1st Line Treatment by Recording Grade 3 and 4 Adverse Events Experienced by Participants in This Trial. Grade 3 or 4 fatigue	5 participants
Safety Objective is to Describe the Safety Profile of 1st Line Treatment by Recording Grade 3 and 4 Adverse Events Experienced by Participants in This Trial. Grade 3 or 4 dehydration	2 participants
Safety Objective is to Describe the Safety Profile of 1st Line Treatment by Recording Grade 3 and 4 Adverse Events Experienced by Participants in This Trial. Grade 3 or 4 nausea	1 participants
Safety Objective is to Describe the Safety Profile of 1st Line Treatment by Recording Grade 3 and 4 Adverse Events Experienced by Participants in This Trial. Grade 3 or 4 diarrhea	2 participants
Safety Objective is to Describe the Safety Profile of 1st Line Treatment by Recording Grade 3 and 4 Adverse Events Experienced by Participants in This Trial. Grade 3 or 4 anorexia	1 participants
Safety Objective is to Describe the Safety Profile of 1st Line Treatment by Recording Grade 3 and 4 Adverse Events Experienced by Participants in This Trial. Grade 3 or 4 neutropenia	3 participants
Safety Objective is to Describe the Safety Profile of 1st Line Treatment by Recording Grade 3 and 4 Adverse Events Experienced by Participants in This Trial. Grade 3 or 4 vomiting	2 participants

Adverse Events

Oxaliplatin + Docetaxel

Serious events: 9 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Oxaliplatin + Docetaxel n=15 participants at risk Oxaliplatin + Docetaxel as first line therapy of Stage IV or IIIB unresectable non-small cell lung cancer
Infections and infestations Catheter infection	6.7% 1/15 • Number of events 1
Gastrointestinal disorders Dehydration	13.3% 2/15 • Number of events 2
Gastrointestinal disorders nausea	6.7% 1/15 • Number of events 1
Gastrointestinal disorders clostridium difficile colitis	6.7% 1/15 • Number of events 1
Respiratory, thoracic and mediastinal disorders hemoptysis	6.7% 1/15 • Number of events 1
General disorders fatigue	6.7% 1/15 • Number of events 1
Nervous system disorders pain	6.7% 1/15 • Number of events 1
Respiratory, thoracic and mediastinal disorders chest pain	6.7% 1/15 • Number of events 1
Cardiac disorders pericardial effusion	6.7% 1/15 • Number of events 1
Gastrointestinal disorders diarrhea	6.7% 1/15 • Number of events 1
Respiratory, thoracic and mediastinal disorders dyspnea	6.7% 1/15 • Number of events 1
Blood and lymphatic system disorders DVT	6.7% 1/15 • Number of events 1
Injury, poisoning and procedural complications concussion	6.7% 1/15 • Number of events 1
Infections and infestations sepsis	6.7% 1/15 • Number of events 1

Other adverse events

Other adverse events
Measure	Oxaliplatin + Docetaxel n=15 participants at risk Oxaliplatin + Docetaxel as first line therapy of Stage IV or IIIB unresectable non-small cell lung cancer
Nervous system disorders Headache	40.0% 6/15 • Number of events 6
Gastrointestinal disorders Nausea	66.7% 10/15 • Number of events 10
Gastrointestinal disorders vomiting	13.3% 2/15 • Number of events 2
General disorders fatigue	46.7% 7/15 • Number of events 7
Metabolism and nutrition disorders anorexia	20.0% 3/15 • Number of events 3
Metabolism and nutrition disorders dehydration	20.0% 3/15 • Number of events 3
Nervous system disorders dysguesia	33.3% 5/15 • Number of events 5
Skin and subcutaneous tissue disorders alopecia	33.3% 5/15 • Number of events 5
Gastrointestinal disorders diarrhea	40.0% 6/15 • Number of events 6
Gastrointestinal disorders constipation	6.7% 1/15 • Number of events 1
Skin and subcutaneous tissue disorders rash	6.7% 1/15 • Number of events 1
Nervous system disorders neuropathy	80.0% 12/15 • Number of events 12
Blood and lymphatic system disorders anemia	80.0% 12/15 • Number of events 12
Vascular disorders thrombocytopenia	33.3% 5/15 • Number of events 5
Blood and lymphatic system disorders neutropenia	40.0% 6/15 • Number of events 6

Additional Information

Chadi Nabhan, MD

Oncology Specialists, S.C.

Phone: 847-268-8200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place