Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov 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
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Jimmy Hwang, Georgetown University

Tracking Information
First Submitted Date  ICMJE March 17, 2009
First Posted Date  ICMJE March 18, 2009
Results First Submitted Date  ICMJE March 24, 2011
Results First Posted Date  ICMJE December 8, 2015
Last Update Posted Date December 8, 2015
Study Start Date  ICMJE October 2007
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 7, 2015)
Progression-free Survival [ Time Frame: 6 months after last patient enrolled ]
Number of days from first dose of study treatment until the date of progression, as measured by worsening disease (new site of disease, or increase in existing disease) or death.
Original Primary Outcome Measures  ICMJE
 (submitted: March 17, 2009)
Progression-free Survival [ Time Frame: 6 months after last patient enrolled ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2015)
  • Objective Response [ Time Frame: Within two months of the completion of the last dose of chemotherapy ]
    Evaluation of tumor extent by CT scans, according to RECIST criteria (a 20% decrease in the sum of the longest unidimensional measurements of existing disease), version 1.0
  • CA 19-9 Response [ Time Frame: Within two months of the last dose of chemotherapy ]
    CA 19-9 was evaluatd every three weeks, before the next study treatment. Approximately 30% of patients are not expected to have detectable CA 19-9, based on Lews-Y antigen. CA 19-9 response is defined as more than 50% decrease from baseline.
  • Number of Participants With Adverse Events [ Time Frame: 30 days after last dose of study drug ]
    Toxicity by National Cancer Institute Common Toxicity Criteria Adverse Event Version 3.0
Original Secondary Outcome Measures  ICMJE
 (submitted: March 17, 2009)
  • Objective Response [ Time Frame: end of study treatment ]
  • Time to progression [ Time Frame: 6 months after last patient enrolled ]
  • CA 19-9 Response [ Time Frame: end of study treatment ]
  • Toxicities [ Time Frame: 30 days after last dose of study drug ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Pemetrexed for Second-Line Pancreas Cancer
Official Title  ICMJE A Phase II Study of Pemetrexed as Second-Line Treatment in Patients With Pancreatic Cancer Progressing Despite Therapy With Gemcitabine
Brief Summary

This study is for patients with pancreatic cancer that has grown and/or spread after having previously received the standard chemotherapy drug called gemcitabine.

In this study a drug called pemetrexed is being tested. This drug is approved by the FDA for use in lung cancer and mesothelioma. The purpose of this study is to see if pemetrexed keeps pancreas cancer that has grown and/or spread after gemcitabine from growing. Subjects will receive pemetrexed IV once every 21 days until disease progression or unacceptable side effects occur.

Detailed Description This is an open label Phase II trial using pemetrexed as second-line treatment in patients with advanced pancreatic cancer progressing within six months of prior gemcitabine-based therapy. Subjects will receive pemetrexed 500 mg/m2 IV every 21 days until disease progression or unacceptable toxicity.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pancreas Cancer
Intervention  ICMJE Drug: pemetrexed
pemetrexed 500 mg/m2 IV day 1 of each 21 day cycle until disease progression or unacceptable toxicity for a maximum of 8 cycles
Other Names:
  • Alimta
  • LY231514
  • NSC# 698037
Study Arms  ICMJE Experimental: chemotherapy
pemetrexed
Intervention: Drug: pemetrexed
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 18, 2009)
17
Original Estimated Enrollment  ICMJE
 (submitted: March 17, 2009)
24
Actual Study Completion Date  ICMJE July 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma of the pancreas
  • Prior treatment for distant or locally advanced disease with gemcitabine-based therapy
  • Measurable or evaluable disease
  • ECOG performance status 0-2
  • Adequate hematological parameters
  • Adequate baseline liver function
  • At least 28 days from any major surgery
  • At least 2 weeks from the last radiation treatment
  • Must have recovered from reversible toxicities of prior chemotherapy
  • Must be able to discontinue any nonsteroidal anti-inflammatory medications
  • Must be willing to receive intramuscular vitamin B12 shots and take oral folate supplements

Exclusion Criteria:

  • Any prior treatment with pemetrexed
  • More than one prior chemotherapy regimen
  • HIV positive on antiretroviral therapy
  • Pregnant or lactating
  • Prior organ allograft
  • On concurrent antitumor therapy including radiation therapy or other chemotherapies
  • Creatinine clearance 45 ml/min or less
  • Absolute neutrophil count < 1500
  • Platelets < 75,000
  • Bilirubin > 1.5 times the upper limit of normal
  • Transaminases > 3 times the upper limit of normal except in known liver metastasis wherein they may be </= 5 times upper limit of normal
  • Clinically significant ascites or pleural effusion that cannot be drained
  • Any medical or psychiatric condition that may interfere with the ability to comply with protocol treatment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00864513
Other Study ID Numbers  ICMJE IIT2007022
2007-022
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jimmy Hwang, Georgetown University
Study Sponsor  ICMJE Georgetown University
Collaborators  ICMJE Eli Lilly and Company
Investigators  ICMJE
Principal Investigator: Jimmy J Hwang, M.D. Georgetown University
PRS Account Georgetown University
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP