Study of Pemetrexed for Second-Line Pancreas Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00864513
Recruitment Status : Terminated (At interim analysis the study did not meet the response criteria to continue)
First Posted : March 18, 2009
Results First Posted : December 8, 2015
Last Update Posted : December 8, 2015
Eli Lilly and Company
Information provided by (Responsible Party):
Jimmy Hwang, Georgetown University

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Pancreas Cancer
Intervention: Drug: pemetrexed

  Participant Flow

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
Withdrawal by Subject                3 

  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.
No text entered.

Reporting Groups
Chemotherapy pemetrexed

Baseline Measures
Overall Participants Analyzed 
[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

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

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

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
First Submitted: March 17, 2009
First Posted: March 18, 2009
Results First Submitted: March 24, 2011
Results First Posted: December 8, 2015
Last Update Posted: December 8, 2015