Adjuvant Cisplatin With Either Genomic-Guided Vinorelbine or Pemetrexed for Early Stage Non-Small-Cell Lung Cancer (TOP0703)

This study has been terminated.
(Study terminated due to reproducibility issues with genomics prediction model.)
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00545948
First received: October 16, 2007
Last updated: June 25, 2014
Last verified: June 2014
Results First Received: May 7, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Carcinoma, Non-Small-Cell Lung
Interventions: Drug: Vinorelbine followed by Cisplatin
Drug: Pemetrexed followed by Cisplatin

  Participant Flow
  Hide Participant Flow

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
A total of 31 patients were registered, but 7 patients were not assigned treatment due to genomic screening failure or study ineligibility. The remaining 24 patients were assigned to the vinorelbine and pemetrexed treatment arms.

Reporting Groups
  Description
Arm A-Vinorelbine Resected tumor was used for genomic expression profiling. Patients with a genomic expression pattern suggestive of vinorelbine sensitivity were given cisplatin + vinorelbine.
Arm B-Pemetrexed Resected tumor was used for genomic expression profiling. Patients with a genomic expression pattern suggestive of pemetrexed sensitivity were given cisplatin + pemetrexed.
Screen Failures

Patients who were registered and underwent protocol-based procedure (e.g. biopsy, genomic screening), but were not assigned to or administered genomics-directed, protocol-based therapy.

Note that two patients who were assigned protocol-based treatment (1 in each arm) did not receive the treatment and were added to the 7 initially identified as screen failures within the summary of baseline characteristics and outcome measures.


Participant Flow:   Overall Study
    Arm A-Vinorelbine     Arm B-Pemetrexed     Screen Failures  
STARTED     9 [1]   15 [2]   7 [3]
Assigned Treatment     9     15     0  
COMPLETED     8 [4]   14 [5]   0  
NOT COMPLETED     1     1     7  
Not Treated                 1                 1                 7  
[1] Registered patients assigned to receive vinorelbine + cisplatin protocol therapy.
[2] Registered patients assigned to receive pemetrexed + cisplatin protocol therapy.
[3] Registered patients who were not assigned to receive protocol therapy.
[4] Patients who received vinorelbine + cisplatin protocol therapy.
[5] Patients who received pemetrexed + cisplatin protocol therapy.



  Baseline Characteristics
  Hide 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.
One patient in each of the vinorelbine and pemetrexed arms did not undergo protocol-based treatment, resulting in 22 total patients who were treated with either vinorelbine or pemetrexed. These two enrolled patients who were not administered treatment were added to the 7 original screen failures.

Reporting Groups
  Description
Arm A-Vinorelbine Resected tumor was used for genomic expression profiling. Patients with a genomic expression pattern suggestive of vinorelbine sensitivity were given cisplatin + vinorelbine.
Arm B-Pemetrexed Resected tumor was used for genomic expression profiling. Patients with a genomic expression pattern suggestive of pemetrexed sensitivity were given cisplatin + pemetrexed.
Screen Failures

Patients who were registered and underwent protocol-based procedure (e.g. biopsy, genomic screening), but were not assigned to or administered genomics-directed, protocol-based therapy.

Note that two patients who were assigned protocol-based treatment (1 in each arm) did not receive the treatment and were added to the 7 initially identified as screen failures within the summary of baseline characteristics and outcome measures.

Total Total of all reporting groups

Baseline Measures
    Arm A-Vinorelbine     Arm B-Pemetrexed     Screen Failures     Total  
Number of Participants  
[units: participants]
  8     14     9     31  
Age  
[units: years]
Mean ± Standard Deviation
  65.13  ± 3.36     58.93  ± 9.14     61.44  ± 11.35     61.18  ± 8.05  
Gender  
[units: participants]
       
Female     3     8     6     17  
Male     5     6     3     14  
Region of Enrollment  
[units: participants]
       
United States     8     14     9     31  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   2-Year Progression-Free Survival Rate in Patients With Completely Resected Stage IB, II, or IIIA NSCLC   [ Time Frame: 2 years ]

2.  Secondary:   Percentage of Patients With Completely Resected NSCLC Tumors That Can Be Analyzed and Used to Direct Adjuvant Chemotherapy   [ Time Frame: 4 years ]

3.  Secondary:   2-Year Overall Survival in Patients Treated for NSCLC   [ Time Frame: 2 years ]

4.  Secondary:   Patient Understanding and Perceptions of Participating in a Clinical Trial Evaluating Cancer Genomics for Adjuvant Treatment of Early Stage Lung Cancer   [ Time Frame: Baseline ]

5.  Secondary:   Compare Drug Sensitivity Patterns of Cisplatin and Pemetrexed in Both Treatment Arms   [ Time Frame: 2 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Neal Ready, PhD, MD
Organization: Duke University Medical Center
phone: 919-681-6932
e-mail: neal.ready@duke.edu


Publications:

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00545948     History of Changes
Other Study ID Numbers: Pro00000657
Study First Received: October 16, 2007
Results First Received: May 7, 2014
Last Updated: June 25, 2014
Health Authority: United States: Institutional Review Board