Trial Outcomes & Findings for Docetaxel and Cisplatin in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer (NCT NCT00118131)

Last Updated: 2023-08-15

Results Overview

Patients experiencing complete or partial response. 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.", or similar definition that is accurate and appropriate.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

49 participants

Primary outcome timeframe

7 years

Results posted on

2023-08-15

Participant Flow

Subjects were recruited from the Cancer Institute of New Jersey (a comprehensive cancer center) and 4 affiliate community hospitals part of the Cancer Institute of New Jersey Oncology Group from December 2003 through February 2008.

Participant milestones

Participant milestones
Measure	Docetaxel and Cisplatin A cycle is defined as an interval of 28 days. Docetaxel, 35 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 105 mg/m2). Cisplatin, 25 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 75 mg/m2). Docetaxel is always to be given prior to cisplatin on Days 1, 8 and 15.
Overall Study STARTED	49
Overall Study COMPLETED	49
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Docetaxel and Cisplatin in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Docetaxel and Cisplatin n=49 Participants A cycle is defined as an interval of 28 days. Docetaxel, 35 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 105 mg/m2). Cisplatin, 25 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 75 mg/m2). Docetaxel is always to be given prior to cisplatin on Days 1, 8 and 15.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	32 Participants n=5 Participants
Age, Categorical >=65 years	17 Participants n=5 Participants
Age, Continuous	63 years STANDARD_DEVIATION 9.9 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants
Region of Enrollment United States	49 participants n=5 Participants

PRIMARY outcome

Timeframe: 7 years

Population: Analysis was performed on the first 47 patients. Study was Terminated before 2 of the patients met the pre-specified time point.

Outcome measures

Outcome measures
Measure	Docetaxel and Cisplatin n=47 Participants A cycle is defined as an interval of 28 days. Docetaxel, 35 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 105 mg/m2). Cisplatin, 25 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 75 mg/m2). Docetaxel is always to be given prior to cisplatin on Days 1, 8 and 15.
Overall Tumor Response Rate	21 percentage of participants

SECONDARY outcome

Timeframe: 8 years

Population: Analysis was performed on the first 47 patients . Study was Terminated before 2 of the patients met the pre-specified time point.

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Outcome measures

Outcome measures
Measure	Docetaxel and Cisplatin n=47 Participants A cycle is defined as an interval of 28 days. Docetaxel, 35 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 105 mg/m2). Cisplatin, 25 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 75 mg/m2). Docetaxel is always to be given prior to cisplatin on Days 1, 8 and 15.
Time to Progressive Disease	3.38 months Interval 2.3 to 5.8

SECONDARY outcome

Timeframe: 1 year

Population: Analysis was performed on the first 47 patients . Study was Terminated before 2 of the patients met the pre-specified time point.

Outcome measures

Outcome measures
Measure	Docetaxel and Cisplatin n=47 Participants A cycle is defined as an interval of 28 days. Docetaxel, 35 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 105 mg/m2). Cisplatin, 25 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 75 mg/m2). Docetaxel is always to be given prior to cisplatin on Days 1, 8 and 15.
1-year Survival Rate	38 percentage of participants

SECONDARY outcome

Timeframe: 10 years

Population: Analysis was performed on the first 47 patients. Study was Terminated before 2 of the patients met the pre-specified time point.

Outcome measures

Outcome measures
Measure	Docetaxel and Cisplatin n=47 Participants A cycle is defined as an interval of 28 days. Docetaxel, 35 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 105 mg/m2). Cisplatin, 25 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 75 mg/m2). Docetaxel is always to be given prior to cisplatin on Days 1, 8 and 15.
Median Survival Time	9.1 months Interval 5.8 to 14.9

Adverse Events

Docetaxel and Cisplatin

Serious events: 18 serious events

Other events: 49 other events

Deaths: 45 deaths

Serious adverse events

Serious adverse events
Measure	Docetaxel and Cisplatin n=49 participants at risk A cycle is defined as an interval of 28 days. Docetaxel, 35 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 105 mg/m2). Cisplatin, 25 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 75 mg/m2). Docetaxel is always to be given prior to cisplatin on Days 1, 8 and 15.
Cardiac disorders Supraventricular arrhythmias (SVT/atrial fibrillation/flutter	4.1% 2/49 • Number of events 2 • From the start of baseline to the end of the study up to 5 years.
Cardiac disorders Hypotension	2.0% 1/49 • Number of events 1 • From the start of baseline to the end of the study up to 5 years.
General disorders Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L)	4.1% 2/49 • Number of events 2 • From the start of baseline to the end of the study up to 5 years.
Gastrointestinal disorders Diarrhea patients without colostomy	6.1% 3/49 • Number of events 3 • From the start of baseline to the end of the study up to 5 years.
Gastrointestinal disorders Nausea	4.1% 2/49 • Number of events 2 • From the start of baseline to the end of the study up to 5 years.
Blood and lymphatic system disorders Hemoptysis	2.0% 1/49 • Number of events 1 • From the start of baseline to the end of the study up to 5 years.
Infections and infestations Infection without neutropenia	4.1% 2/49 • Number of events 2 • From the start of baseline to the end of the study up to 5 years.
Investigations Hyperglycemia	2.0% 1/49 • Number of events 1 • From the start of baseline to the end of the study up to 5 years.
Investigations Hypokalemia	2.0% 1/49 • Number of events 1 • From the start of baseline to the end of the study up to 5 years.
Investigations Hypomagnesemia	2.0% 1/49 • Number of events 1 • From the start of baseline to the end of the study up to 5 years.
Investigations Hyponatremia	2.0% 1/49 • Number of events 1 • From the start of baseline to the end of the study up to 5 years.
Nervous system disorders Dizziness/lightheadedness	2.0% 1/49 • Number of events 1 • From the start of baseline to the end of the study up to 5 years.
Nervous system disorders Seizure(s)	2.0% 1/49 • Number of events 1 • From the start of baseline to the end of the study up to 5 years.
Respiratory, thoracic and mediastinal disorders Cough	2.0% 1/49 • Number of events 1 • From the start of baseline to the end of the study up to 5 years.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	10.2% 5/49 • Number of events 5 • From the start of baseline to the end of the study up to 5 years.
Respiratory, thoracic and mediastinal disorders Pneumonitis/pulmonary infiltrates	2.0% 1/49 • Number of events 1 • From the start of baseline to the end of the study up to 5 years.
Respiratory, thoracic and mediastinal disorders Pulmonary-Other (Specify, RLL pneumonia)	2.0% 1/49 • Number of events 1 • From the start of baseline to the end of the study up to 5 years.
Respiratory, thoracic and mediastinal disorders Pulmonary-Other (Specify, respiratory distress)	2.0% 1/49 • Number of events 1 • From the start of baseline to the end of the study up to 5 years.
Vascular disorders Thrombosis/embolism	2.0% 1/49 • Number of events 1 • From the start of baseline to the end of the study up to 5 years.
Vascular disorders Thrombosis/embolism - pulmonary embolism	2.0% 1/49 • Number of events 1 • From the start of baseline to the end of the study up to 5 years.
Nervous system disorders Confusion	2.0% 1/49 • Number of events 1 • From the start of baseline to the end of the study up to 5 years.
Blood and lymphatic system disorders Leukocytes	2.0% 1/49 • Number of events 1 • From the start of baseline to the end of the study up to 5 years.
Nervous system disorders Syncope	2.0% 1/49 • Number of events 1 • From the start of baseline to the end of the study up to 5 years.
General disorders Fatigue	2.0% 1/49 • Number of events 1 • From the start of baseline to the end of the study up to 5 years.

Other adverse events

Other adverse events
Measure	Docetaxel and Cisplatin n=49 participants at risk A cycle is defined as an interval of 28 days. Docetaxel, 35 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 105 mg/m2). Cisplatin, 25 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 75 mg/m2). Docetaxel is always to be given prior to cisplatin on Days 1, 8 and 15.
Gastrointestinal disorders Diarrhea patients without colostomy	46.9% 23/49 • Number of events 31 • From the start of baseline to the end of the study up to 5 years.
Gastrointestinal disorders Nausea	38.8% 19/49 • Number of events 26 • From the start of baseline to the end of the study up to 5 years.
Gastrointestinal disorders Constipation	32.7% 16/49 • Number of events 18 • From the start of baseline to the end of the study up to 5 years.
Gastrointestinal disorders Taste disturbance (dysgeusia)	30.6% 15/49 • Number of events 19 • From the start of baseline to the end of the study up to 5 years.
Gastrointestinal disorders Anorexia	28.6% 14/49 • Number of events 15 • From the start of baseline to the end of the study up to 5 years.
Gastrointestinal disorders Vomiting	18.4% 9/49 • Number of events 12 • From the start of baseline to the end of the study up to 5 years.
Gastrointestinal disorders Stomatitis/pharyngitis (oral/pharyngeal mucositis)	16.3% 8/49 • Number of events 8 • From the start of baseline to the end of the study up to 5 years.
Gastrointestinal disorders Dyspepsia/heartburn	10.2% 5/49 • Number of events 5 • From the start of baseline to the end of the study up to 5 years.
Gastrointestinal disorders Dehydration	10.2% 5/49 • Number of events 5 • From the start of baseline to the end of the study up to 5 years.
Gastrointestinal disorders Gastrointestinal	10.2% 5/49 • Number of events 5 • From the start of baseline to the end of the study up to 5 years.
Skin and subcutaneous tissue disorders Dermatology/Skin	14.3% 7/49 • Number of events 9 • From the start of baseline to the end of the study up to 5 years.
Skin and subcutaneous tissue disorders Alopecia	46.9% 23/49 • Number of events 27 • From the start of baseline to the end of the study up to 5 years.
Skin and subcutaneous tissue disorders Dry skin	6.1% 3/49 • Number of events 4 • From the start of baseline to the end of the study up to 5 years.
Skin and subcutaneous tissue disorders Nail changes	6.1% 3/49 • Number of events 4 • From the start of baseline to the end of the study up to 5 years.
Skin and subcutaneous tissue disorders Rash/desquamation	6.1% 3/49 • Number of events 3 • From the start of baseline to the end of the study up to 5 years.
General disorders Fatigue (lethargy, malaise, asthenia)	51.0% 25/49 • Number of events 29 • From the start of baseline to the end of the study up to 5 years.
General disorders Weight loss	10.2% 5/49 • Number of events 6 • From the start of baseline to the end of the study up to 5 years.
General disorders Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L)	6.1% 3/49 • Number of events 4 • From the start of baseline to the end of the study up to 5 years.
Nervous system disorders Neuropathy-sensory	24.5% 12/49 • Number of events 16 • From the start of baseline to the end of the study up to 5 years.
Psychiatric disorders Mood alteration-anxiety, agitation	14.3% 7/49 • Number of events 8 • From the start of baseline to the end of the study up to 5 years.
Nervous system disorders Insomnia	12.2% 6/49 • Number of events 9 • From the start of baseline to the end of the study up to 5 years.
Nervous system disorders Dizziness/lightheadedness	10.2% 5/49 • Number of events 5 • From the start of baseline to the end of the study up to 5 years.
Psychiatric disorders Mood alteration-depression	10.2% 5/49 • Number of events 5 • From the start of baseline to the end of the study up to 5 years.
Nervous system disorders Neuropathy - motor	8.2% 4/49 • Number of events 4 • From the start of baseline to the end of the study up to 5 years.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	38.8% 19/49 • Number of events 25 • From the start of baseline to the end of the study up to 5 years.
Respiratory, thoracic and mediastinal disorders Cough	32.7% 16/49 • Number of events 16 • From the start of baseline to the end of the study up to 5 years.
Respiratory, thoracic and mediastinal disorders Pulmonary	12.2% 6/49 • Number of events 6 • From the start of baseline to the end of the study up to 5 years.
General disorders Pain	20.4% 10/49 • Number of events 13 • From the start of baseline to the end of the study up to 5 years.
General disorders Bone pain	8.2% 4/49 • Number of events 4 • From the start of baseline to the end of the study up to 5 years.
Musculoskeletal and connective tissue disorders Myalgia (muscle pain)	6.1% 3/49 • Number of events 3 • From the start of baseline to the end of the study up to 5 years.
Blood and lymphatic system disorders Leukocytes (total WBC)	20.4% 10/49 • Number of events 12 • From the start of baseline to the end of the study up to 5 years.
Blood and lymphatic system disorders Blood/Bone Marrow	10.2% 5/49 • Number of events 7 • From the start of baseline to the end of the study up to 5 years.
Blood and lymphatic system disorders Neutrophils/granulocytes (ANC/AGC)	10.2% 5/49 • Number of events 7 • From the start of baseline to the end of the study up to 5 years.
Blood and lymphatic system disorders Hemoglobin	8.2% 4/49 • Number of events 6 • From the start of baseline to the end of the study up to 5 years.
Vascular disorders Thrombosis/embolism	8.2% 4/49 • Number of events 4 • From the start of baseline to the end of the study up to 5 years.
Vascular disorders Edema	18.4% 9/49 • Number of events 11 • From the start of baseline to the end of the study up to 5 years.
Renal and urinary disorders Creatinine	8.2% 4/49 • Number of events 7 • From the start of baseline to the end of the study up to 5 years.
Renal and urinary disorders Renal/Genitourinary	8.2% 4/49 • Number of events 5 • From the start of baseline to the end of the study up to 5 years.
Investigations Hypomagnesemia	12.2% 6/49 • Number of events 6 • From the start of baseline to the end of the study up to 5 years.
Investigations Hyponatremia	10.2% 5/49 • Number of events 5 • From the start of baseline to the end of the study up to 5 years.
Investigations Hypokalemia	8.2% 4/49 • Number of events 4 • From the start of baseline to the end of the study up to 5 years.
Investigations Hyperglycemia	6.1% 3/49 • Number of events 6 • From the start of baseline to the end of the study up to 5 years.
Eye disorders Ocular/Visual	8.2% 4/49 • Number of events 4 • From the start of baseline to the end of the study up to 5 years.
Eye disorders Tearing (watery eyes)	8.2% 4/49 • Number of events 5 • From the start of baseline to the end of the study up to 5 years.
Infections and infestations Infection without neutropenia	10.2% 5/49 • Number of events 6 • From the start of baseline to the end of the study up to 5 years.
Blood and lymphatic system disorders Hemoptysis	8.2% 4/49 • Number of events 4 • From the start of baseline to the end of the study up to 5 years.
Cardiac disorders Palpitations	6.1% 3/49 • Number of events 3 • From the start of baseline to the end of the study up to 5 years.
Immune system disorders Allergic reaction/hypersensitivity (including drug fever)	6.1% 3/49 • Number of events 3 • From the start of baseline to the end of the study up to 5 years.
Hepatobiliary disorders Hypoalbuminemia	8.2% 4/49 • Number of events 4 • From the start of baseline to the end of the study up to 5 years.

Additional Information

Dr. Joseph Aisner

Cancer Institute of New Jersey

Phone: 732-235-8675

Email: [email protected]; [email protected]; [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place