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Study of Pemetrexed for Second-Line Pancreas Cancer

This study has been terminated.
(At interim analysis the study did not meet the response criteria to continue)
Eli Lilly and Company
Information provided by (Responsible Party):
Jimmy Hwang, Georgetown University Identifier:
First received: March 17, 2009
Last updated: December 7, 2015
Last verified: December 2015
Results First Received: March 24, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Pancreas Cancer
Intervention: 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
From 12/2007 to 3/2009 17 patients were enrolled; 2 of which did not receive any treatment.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
Chemotherapy Subjects will be treated with pemetrexed 500 mg/m2 IV once every 21 days. They are also premdicated with dexamethasone 4 mg po BID on the day before, of and after chemotherapy. They will start folic acid 350-1000mcg by mouth daily, 5-7 days before starting study therapy. They will also receive a 1000 mcg IM injeciton of vitamin B12 1-2 weeks before study drug, and eveyr 9 weeks thereafter, until 3 weeks after the last dose of study treatment

Participant Flow:   Overall Study
STARTED     15  
COMPLETED     12  
Withdrawal by Subject                 3  

  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
Chemotherapy pemetrexed

Baseline Measures
Number of Participants  
[units: participants]
[units: participants]
<=18 years     0  
Between 18 and 65 years     11  
>=65 years     4  
[units: years]
Mean (Standard Deviation)
  55  (30)  
[units: participants]
Female     4  
Male     11  
Region of Enrollment  
[units: participants]
United States     15  

  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression-free Survival   [ Time Frame: 6 months after last patient enrolled ]

2.  Secondary:   Objective Response   [ Time Frame: Within two months of the completion of the last dose of chemotherapy ]

3.  Secondary:   CA 19-9 Response   [ Time Frame: Within two months of the last dose of chemotherapy ]

4.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: 30 days after last dose of study drug ]

  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
study was closed at interim analysis so only 12 subjects were evaluable for response, 15 subjects received treatment and were evaluable for adverse events

  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: Dr. Jimmy Hwang
Organization: Georgetown University
phone: 202-444-2198

Responsible Party: Jimmy Hwang, Georgetown University Identifier: NCT00864513     History of Changes
Other Study ID Numbers: IIT2007022
Study First Received: March 17, 2009
Results First Received: March 24, 2011
Last Updated: December 7, 2015
Health Authority: United States: Institutional Review Board