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

This study has been terminated.
(Slow accrual)
Sponsor:
Collaborators:
Aventis Pharmaceuticals
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier:
NCT00118131
First received: July 8, 2005
Last updated: September 19, 2013
Last verified: September 2013
Results First Received: September 19, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Lung Cancer
Interventions: Drug: cisplatin
Drug: docetaxel

  Participant Flow
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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
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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  
Number of Participants  
[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
  Show All 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
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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
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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


No publications provided


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, CINJ-030302, CINJ-NJ1503
Study First Received: July 8, 2005
Results First Received: September 19, 2013
Last Updated: September 19, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board