Pemetrexed &Oxaliplatin in Patients w Recurrent NSCLCa After Failure to Platinum Based Adjuvant Chem

This study has been terminated.
(slow accrual - the 1 patient accrued did not go on treatment)
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT00612677
First received: January 29, 2008
Last updated: December 13, 2013
Last verified: December 2013
Results First Received: February 21, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Lung Cancer
Interventions: Drug: Oxaliplatin
Drug: Pemetrexed

  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
No text entered.

Reporting Groups
  Description
Chemotherapy Single arm, two stage design Phase II study offered through the Moffitt Clinical Research Affiliate Network

Participant Flow:   Overall Study
    Chemotherapy  
STARTED     1  
COMPLETED     0  
NOT COMPLETED     1  
study closed before treatment started                 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.
No text entered.

Reporting Groups
  Description
Chemotherapy Single arm, two stage design Phase II study offered through the Moffitt Clinical Research Affiliate Network

Baseline Measures
    Chemotherapy  
Number of Participants  
[units: participants]
  1  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     0  
>=65 years     1  
Gender  
[units: participants]
 
Female     0  
Male     1  
Region of Enrollment  
[units: participants]
 
United States     1  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Patients Who Responded to Treatment   [ Time Frame: Patient will continue study treatment until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 3 weeks. ]

2.  Secondary:   Time to Progression (TTP)   [ Time Frame: Patient will continue study treatment until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 3 weeks. ]

3.  Secondary:   Number of Participants Who Experienced Toxicities   [ Time Frame: Patient will continue study treatment until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 3 weeks. ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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
Terminated due to slow accrual. Study closed before treatment started.  


Results Point of Contact:  
Name/Title: Alberto Chiappori, M.D., via Moffitt Cancer Center
Organization: H. Lee Moffitt Cancer Center and Research Institute
phone: 813-745-3050
e-mail: alberto.chiappori@moffitt.org


No publications provided


Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT00612677     History of Changes
Other Study ID Numbers: MCC-15010, OX-04-006
Study First Received: January 29, 2008
Results First Received: February 21, 2011
Last Updated: December 13, 2013
Health Authority: United States: Institutional Review Board