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)
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Jimmy Hwang, Georgetown University
ClinicalTrials.gov Identifier:
NCT00864513
First received: March 17, 2009
Last updated: December 7, 2015
Last verified: December 2015

March 17, 2009
December 7, 2015
October 2007
July 2009   (final data collection date for primary outcome measure)
Progression-free Survival [ Time Frame: 6 months after last patient enrolled ] [ Designated as safety issue: No ]
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.
Progression-free Survival [ Time Frame: 6 months after last patient enrolled ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00864513 on ClinicalTrials.gov Archive Site
  • Objective Response [ Time Frame: Within two months of the completion of the last dose of chemotherapy ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Toxicity by National Cancer Institute Common Toxicity Criteria Adverse Event Version 3.0
  • Objective Response [ Time Frame: end of study treatment ] [ Designated as safety issue: No ]
  • Time to progression [ Time Frame: 6 months after last patient enrolled ] [ Designated as safety issue: No ]
  • CA 19-9 Response [ Time Frame: end of study treatment ] [ Designated as safety issue: No ]
  • Toxicities [ Time Frame: 30 days after last dose of study drug ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Study of Pemetrexed for Second-Line Pancreas Cancer
A Phase II Study of Pemetrexed as Second-Line Treatment in Patients With Pancreatic Cancer Progressing Despite Therapy With Gemcitabine

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.

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.
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pancreas Cancer
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
Experimental: chemotherapy
pemetrexed
Intervention: Drug: pemetrexed
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
17
July 2009
July 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00864513
IIT2007022, 2007-022
Yes
Not Provided
Not Provided
Jimmy Hwang, Georgetown University
Georgetown University
Eli Lilly and Company
Principal Investigator: Jimmy J Hwang, M.D. Georgetown University
Georgetown University
December 2015

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