Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00118131
Recruitment Status : Terminated (Slow accrual)
First Posted : July 11, 2005
Results First Posted : November 25, 2013
Last Update Posted : November 25, 2013
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Aventis Pharmaceuticals
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lung Cancer
Interventions Drug: cisplatin
Drug: docetaxel
Enrollment 49
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Docetaxel and Cisplatin
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 49
Completed 49
Not Completed 0
Arm/Group Title Docetaxel and Cisplatin
Hide Arm/Group Description

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 Number of Baseline Participants 49
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants
<=18 years
0
   0.0%
Between 18 and 65 years
32
  65.3%
>=65 years
17
  34.7%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 49 participants
63  (9.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants
Female
22
  44.9%
Male
27
  55.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 49 participants
49
1.Primary Outcome
Title Overall Tumor Response Rate
Hide Description Patients experiencing complete or partial response
Time Frame 7 years
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the first 47 patients only as it was too early to collect data for the last 2 patients.
Arm/Group Title Docetaxel and Cisplatin
Hide Arm/Group Description:

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 Number of Participants Analyzed 47
Measure Type: Number
Unit of Measure: Response rate (percentage)
21
2.Secondary Outcome
Title Time to Progressive Disease
Hide Description [Not Specified]
Time Frame 8 years
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the first 47 patients only as it was too early to collect data for the last 2 patients.
Arm/Group Title Docetaxel and Cisplatin
Hide Arm/Group Description:

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 Number of Participants Analyzed 47
Median (95% Confidence Interval)
Unit of Measure: months
3.38
(2.3 to 5.8)
3.Secondary Outcome
Title 1-year Survival Rate
Hide Description [Not Specified]
Time Frame 8 years
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the first 47 patients only as it was too early to collect data for the last 2 patients.
Arm/Group Title Docetaxel and Cisplatin
Hide Arm/Group Description:

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 Number of Participants Analyzed 47
Measure Type: Number
Unit of Measure: 1-year survival rate (percentage)
38
4.Secondary Outcome
Title Median Survival Time
Hide Description [Not Specified]
Time Frame 10 years
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the first 47 patients only as it was too early to collect data for the last 2 patients.
Arm/Group Title Docetaxel and Cisplatin
Hide Arm/Group Description:

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 Number of Participants Analyzed 47
Median (95% Confidence Interval)
Unit of Measure: months
9.1
(5.8 to 14.9)
Time Frame 5 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Docetaxel and Cisplatin
Hide Arm/Group Description

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.

All-Cause Mortality
Docetaxel and Cisplatin
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Docetaxel and Cisplatin
Affected / at Risk (%) # Events
Total   18/49 (36.73%)    
Blood and lymphatic system disorders   
Hemoptysis * 1  1/49 (2.04%)  1
Leukocytes * 1  1/49 (2.04%)  1
Cardiac disorders   
Supraventricular arrhythmias (SVT/atrial fibrillation/flutter * 1  2/49 (4.08%)  2
Hypotension * 1  1/49 (2.04%)  1
Gastrointestinal disorders   
Diarrhea patients without colostomy * 1  3/49 (6.12%)  3
Nausea * 1  2/49 (4.08%)  2
General disorders   
Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L) * 1  2/49 (4.08%)  2
Fatigue * 1  1/49 (2.04%)  1
Infections and infestations   
Infection without neutropenia * 1  2/49 (4.08%)  2
Investigations   
Hyperglycemia * 1  1/49 (2.04%)  1
Hypokalemia * 1  1/49 (2.04%)  1
Hypomagnesemia * 1  1/49 (2.04%)  1
Hyponatremia * 1  1/49 (2.04%)  1
Nervous system disorders   
Dizziness/lightheadedness * 1  1/49 (2.04%)  1
Seizure(s) * 1  1/49 (2.04%)  1
Confusion * 1  1/49 (2.04%)  1
Syncope * 1  1/49 (2.04%)  1
Respiratory, thoracic and mediastinal disorders   
Cough * 1  1/49 (2.04%)  1
Dyspnea (shortness of breath) * 1  5/49 (10.20%)  5
Pneumonitis/pulmonary infiltrates * 1  1/49 (2.04%)  1
Pulmonary-Other (Specify, RLL pneumonia) * 1  1/49 (2.04%)  1
Pulmonary-Other (Specify, respiratory distress) * 1  1/49 (2.04%)  1
Vascular disorders   
Thrombosis/embolism * 1  1/49 (2.04%)  1
Thrombosis/embolism - pulmonary embolism * 1  1/49 (2.04%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Docetaxel and Cisplatin
Affected / at Risk (%) # Events
Total   49/49 (100.00%)    
Blood and lymphatic system disorders   
Leukocytes (total WBC) * 1  10/49 (20.41%)  12
Blood/Bone Marrow-Other (Specify,_____) * 1  5/49 (10.20%)  7
Neutrophils/granulocytes (ANC/AGC) * 1  5/49 (10.20%)  7
Hemoglobin * 1  4/49 (8.16%)  6
Hemoptysis * 1  4/49 (8.16%)  4
Cardiac disorders   
Palpitations * 1  3/49 (6.12%)  3
Eye disorders   
Ocular/Visual-Other (Specify,___) * 1  4/49 (8.16%)  4
Tearing (watery eyes) * 1  4/49 (8.16%)  5
Gastrointestinal disorders   
Diarrhea patients without colostomy * 1  23/49 (46.94%)  31
Nausea * 1  19/49 (38.78%)  26
Constipation * 1  16/49 (32.65%)  18
Taste disturbance (dysgeusia) * 1  15/49 (30.61%)  19
Anorexia * 1  14/49 (28.57%)  15
Vomiting * 1  9/49 (18.37%)  12
Stomatitis/pharyngitis (oral/pharyngeal mucositis) * 1  8/49 (16.33%)  8
Dyspepsia/heartburn * 1  5/49 (10.20%)  5
Dehydration * 1  5/49 (10.20%)  5
Gastrointestinal-Other (Specify,_____) * 1  5/49 (10.20%)  5
General disorders   
Fatigue (lethargy, malaise, asthenia) * 1  25/49 (51.02%)  29
Weight loss * 1  5/49 (10.20%)  6
Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L) * 1  3/49 (6.12%)  4
Pain-Other (Specify,___) * 1  10/49 (20.41%)  13
Bone pain * 1  4/49 (8.16%)  4
Hepatobiliary disorders   
Hypoalbuminemia * 1  4/49 (8.16%)  4
Immune system disorders   
Allergic reaction/hypersensitivity (including drug fever) * 1  3/49 (6.12%)  3
Infections and infestations   
Infection without neutropenia * 1  5/49 (10.20%)  6
Investigations   
Hypomagnesemia * 1  6/49 (12.24%)  6
Hyponatremia * 1  5/49 (10.20%)  5
Hypokalemia * 1  4/49 (8.16%)  4
Hyperglycemia * 1  3/49 (6.12%)  6
Musculoskeletal and connective tissue disorders   
Myalgia (muscle pain) * 1  3/49 (6.12%)  3
Nervous system disorders   
Neuropathy-sensory * 1  12/49 (24.49%)  16
Insomnia * 1  6/49 (12.24%)  9
Dizziness/lightheadedness * 1  5/49 (10.20%)  5
Neuropathy - motor * 1  4/49 (8.16%)  4
Psychiatric disorders   
Mood alteration-anxiety, agitation * 1  7/49 (14.29%)  8
Mood alteration-depression * 1  5/49 (10.20%)  5
Renal and urinary disorders   
Creatinine * 1  4/49 (8.16%)  7
Renal/Genitourinary-Other (Specify,____) * 1  4/49 (8.16%)  5
Respiratory, thoracic and mediastinal disorders   
Dyspnea (shortness of breath) * 1  19/49 (38.78%)  25
Cough * 1  16/49 (32.65%)  16
Pulmonary-Other (Specify,___) * 1  6/49 (12.24%)  6
Skin and subcutaneous tissue disorders   
Dermatology/Skin-Other (Specify,_____) * 1  7/49 (14.29%)  9
Alopecia * 1  23/49 (46.94%)  27
Dry skin * 1  3/49 (6.12%)  4
Nail changes * 1  3/49 (6.12%)  4
Rash/desquamation * 1  3/49 (6.12%)  3
Vascular disorders   
Thrombosis/embolism * 1  4/49 (8.16%)  4
Edema * 1  9/49 (18.37%)  11
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Joseph Aisner
Organization: Cancer Institute of New Jersey
Phone: 732-235-8675
Responsible Party: Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier: NCT00118131     History of Changes
Other Study ID Numbers: CDR0000433488
P30CA072720 ( U.S. NIH Grant/Contract )
CINJ-030302 ( Other Identifier: Cancer Institute of New Jersey )
CINJ-NJ1503 ( Other Identifier: Cancer Institute of New Jersey )
First Submitted: July 8, 2005
First Posted: July 11, 2005
Results First Submitted: September 19, 2013
Results First Posted: November 25, 2013
Last Update Posted: November 25, 2013