Bortezomib, Paclitaxel, Carboplatin and Radiation Therapy for Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00093756
First received: October 6, 2004
Last updated: December 3, 2014
Last verified: November 2013
Results First Received: November 25, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Recurrent Non-small Cell Lung Cancer
Stage IIIA Non-small Cell Lung Cancer
Stage IIIB Non-small Cell Lung Cancer
Interventions: Radiation: 3-dimensional conformal radiation therapy
Drug: bortezomib
Drug: paclitaxel
Drug: carboplatin

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Fifty two (52) patients were accrued, out of which 4 were cancels. Twenty one (21) patients were accrued for phase I portion of the study. Twenty Seven (27) patients are accrued for phase II portion of the study. Twenty Seven (27) Phase II patients are evaluable for primary outcome measure.

Reporting Groups
  Description
PhaseI PHASE I: Cohorts of 3-6 patients receive escalating doses of study medications until the maximum tolerated dose (MTD) is determined. 3-dimensional conformal radiation therapy, bortezomib: Given IV, paclitaxel: Given IV, carboplatin: Given IV.
PhaseII PHASE II: Patients receive as in phase I at the MTD. Patients also undergo radiotherapy as in phase I. 3-dimensional conformal radiation therapy, bortezomib: Given IV, paclitaxel: Given IV, , carboplatin: Given IV.

Participant Flow:   Overall Study
    PhaseI     PhaseII  
STARTED     21     27  
COMPLETED     21     27  
NOT COMPLETED     0     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
PhaseI PHASE I: Cohorts of 3-6 patients receive escalating doses of study medications until the maximum tolerated dose (MTD) is determined. 3-dimensional conformal radiation therapy > bortezomib: Given IV > paclitaxel: Given IV > carboplatin: Given IV
PhaseII PHASE II: Patients receive as in phase I at the MTD. Patients also undergo radiotherapy as in phase I. 3-dimensional conformal radiation therapy > bortezomib: Given IV > paclitaxel: Given IV > carboplatin: Given IV
Total Total of all reporting groups

Baseline Measures
    PhaseI     PhaseII     Total  
Number of Participants  
[units: participants]
  21     27     48  
Age  
[units: years]
Median (Full Range)
  65    (43 to 78)     58    (43 to 79)     63    (43 to 79)  
Gender  
[units: participants]
     
Female     8     10     18  
Male     13     17     30  
Region of Enrollment  
[units: participants]
     
United States     21     27     48  



  Outcome Measures

1.  Primary:   The Primary Endpoint of This Trial is the Proportion of Patients Alive at 1 Year. Phase II Patients Only.   [ Time Frame: At 1 year ]

2.  Secondary:   Confirmed Tumor Response, Defined as a Complete or Partial Response Noted as the Objective Status on 2 Consecutive Evaluations at Least 4 Weeks Apart   [ Time Frame: Up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Time to Progression   [ Time Frame: From study registration to date of disease progression or date of last follow-up, up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Progression-free Survival   [ Time Frame: From study registration to the first of either death due to any cause or progression, up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Survival Time   [ Time Frame: From registration to death due to any cause, up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Frequency and Severity of Observed Toxicity, Graded by Common Terminology Criteria for Adverse Events (CTCAE)   [ Time Frame: Up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  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:  
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: Alex A. Adjei, M.D., Ph.D.
Organization: Roswell Park Cancer Institute
phone: 507/284- 9265
e-mail: alex.adjei@roswellpark.org


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00093756     History of Changes
Other Study ID Numbers: NCI-2009-00643, NCI-2009-00643, CDR0000390108, NCCTG-N0321, N0321, N0321, U10CA025224
Study First Received: October 6, 2004
Results First Received: November 25, 2013
Last Updated: December 3, 2014
Health Authority: United States: Food and Drug Administration