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Carboplatin and Paclitaxel Albumin-Stabilized Nanoparticle Formulation Followed by Radiation Therapy and Erlotinib in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed By Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00553462
First received: November 2, 2007
Last updated: November 23, 2016
Last verified: November 2016
Results First Received: November 23, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Lung Cancer
Interventions: Drug: carboplatin
Drug: erlotinib hydrochloride
Drug: paclitaxel albumin-stabilized nanoparticle formulation
Radiation: radiation therapy

  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
Between March 2008 and October 2011, 78 participants were recruited to this study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Three participants did not receive any protocol treatment and were excluded from all analyses.

Reporting Groups
  Description
Paclitaxel + Carboplatin + Radiation + Erlotinib

Patients receive paclitaxel 100 mg/m^2 IV over 30 minutes on days 1 and 8 and carboplatin AUC=5 IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses.

Beginning on day 43 (week 7), patients receive oral erlotinib hydrochloride 150 mg once daily. Patients also undergo concurrent radiotherapy 200 cGy/day, 5 days a week for up to 7 weeks (33 fractions), total dose of 6600 cGy.


Participant Flow:   Overall Study
    Paclitaxel + Carboplatin + Radiation + Erlotinib
STARTED   75 
COMPLETED   61 
NOT COMPLETED   14 
Adverse Event                4 
Progression                4 
Withdrawal by Subject                5 
Physician Decision                1 



  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.
Three participants did not receive any protocol treatment and were excluded from all analyses.

Reporting Groups
  Description
Paclitaxel + Carboplatin + Radiation + Erlotinib

Patients receive paclitaxel 100 mg/m^2 IV over 30 minutes on days 1 and 8 and carboplatin AUC=5 IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses.

Beginning on day 43 (week 7), patients receive oral erlotinib hydrochloride 150 mg once daily. Patients also undergo concurrent radiotherapy 200 cGy/day, 5 days a week for up to 7 weeks (33 fractions), total dose of 6600 cGy.


Baseline Measures
   Paclitaxel + Carboplatin + Radiation + Erlotinib 
Overall Participants Analyzed 
[Units: Participants]
 75 
Age 
[Units: Years]
Median (Full Range)
 68 
 (39 to 88) 
Gender 
[Units: Participants]
Count of Participants
 
Female      31  41.3% 
Male      44  58.7% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      3   4.0% 
Not Hispanic or Latino      69  92.0% 
Unknown or Not Reported      3   4.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      1   1.3% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      20  26.7% 
White      53  70.7% 
More than one race      1   1.3% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   75 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Survival at 12 Months   [ Time Frame: At 12 months ]

2.  Secondary:   Response Rate   [ Time Frame: Duration of study (up to 2 years) ]

3.  Secondary:   Progression-free Survival   [ Time Frame: Duration of study (up to 2 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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Rogerio Lilenbaum, M.D.
Organization: Yale Cancer Center
e-mail: Rogerio.lilenbaum@yale.edu



Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00553462     History of Changes
Other Study ID Numbers: CALGB-30605
CDR0000573832 ( Registry Identifier: NCI Physician Data Query )
Study First Received: November 2, 2007
Results First Received: November 23, 2016
Last Updated: November 23, 2016