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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:
Information provided by (Responsible Party):

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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    Docetaxel and Cisplatin
STARTED   49 
COMPLETED   49 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.


Baseline Measures
   Docetaxel and Cisplatin 
Overall Participants Analyzed 
[Units: Participants]
 49 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   32 
>=65 years   17 
Age 
[Units: Years]
Mean (Standard Deviation)
 63  (9.9) 
Gender 
[Units: Participants]
 
Female   22 
Male   27 
Region of Enrollment 
[Units: Participants]
 
United States   49 


  Outcome Measures

1.  Primary:   Overall Tumor Response Rate   [ Time Frame: 7 years ]

2.  Secondary:   Time to Progressive Disease   [ Time Frame: 8 years ]

3.  Secondary:   1-year Survival Rate   [ Time Frame: 8 years ]

4.  Secondary:   Median Survival Time   [ Time Frame: 10 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: aisnerjo@cinj.rutgers.edu; rizzoji@cinj.rutgers.edu; zelinsta@cinj.rutgers.edu



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