A Phase II Study of Pemetrexed and Carboplatin in the Treatment of Esophageal Cancer

This study has been terminated.
(Low accrual)
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00383266
First received: October 2, 2006
Last updated: December 4, 2015
Last verified: December 2015
Results First Received: October 20, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Esophageal Neoplasms
Interventions: Drug: Pemetrexed
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
The study opened to participant enrollment on 10/11/2006 and closed to participant enrollment on 11/12/2009.

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
Pemetrexed + Carboplatin
  • Pemetrexed 500 mg/m^2 IV over 10 minutes
  • Carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle
  • Each cycle will last 21 days.

Participant Flow:   Overall Study
    Pemetrexed + Carboplatin  
STARTED     9  
COMPLETED     9  
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
Pemetrexed + Carboplatin
  • Pemetrexed 500 mg/m2 IV over 10 minutes
  • Carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle
  • Each cycle will last 21 days.

Baseline Measures
    Pemetrexed + Carboplatin  
Number of Participants  
[units: participants]
  9  
Age  
[units: years]
Median (Full Range)
  62   (42 to 71)  
Gender  
[units: participants]
 
Female     2  
Male     7  
Region of Enrollment  
[units: participants]
 
United States     9  



  Outcome Measures
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1.  Primary:   Overall Response Rate (ORR)   [ Time Frame: Until patient progresses or dies (median follow-up 293 days -- range (63-632 days) ]

2.  Secondary:   Time to Disease Progression   [ Time Frame: Until patient progresses (median follow-up 293 days -- range (63-632 days) ]

3.  Secondary:   Overall Survival Rate   [ Time Frame: 1 year ]

4.  Secondary:   Toxicities   [ Time Frame: 30 days following completion of treatment (maximum number of cycles = 6) ]

5.  Secondary:   Overall Survival Rate   [ Time Frame: 2 years ]

6.  Secondary:   Overall Survival (OS)   [ Time Frame: Until patient's death (median follow-up 293 days -- range (63-632 days)) ]


  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
The study was terminated due to lack of participant accrual.


  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: Maria Baggstrom, M.D.
Organization: Washington University School of Medicine
phone: 314-362-5740
e-mail: mbaggstr@dom.wustl.edu


No publications provided


Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00383266     History of Changes
Other Study ID Numbers: 06-0541 / 201103198
Study First Received: October 2, 2006
Results First Received: October 20, 2015
Last Updated: December 4, 2015
Health Authority: United States: Institutional Review Board