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
  Purpose

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.


Condition Intervention Phase
Pancreas Cancer
Drug: pemetrexed
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Pemetrexed as Second-Line Treatment in Patients With Pancreatic Cancer Progressing Despite Therapy With Gemcitabine

Resource links provided by NLM:


Further study details as provided by Georgetown University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 17
Study Start Date: October 2007
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: chemotherapy
pemetrexed
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00864513

Locations
United States, District of Columbia
Georgetown University Hospital/Lombardi Cancer Center
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
Eli Lilly and Company
Investigators
Principal Investigator: Jimmy J Hwang, M.D. Georgetown University
  More Information

Responsible Party: Jimmy Hwang, Principal Investigator, Georgetown University
ClinicalTrials.gov Identifier: NCT00864513     History of Changes
Other Study ID Numbers: IIT2007022  2007-022 
Study First Received: March 17, 2009
Results First Received: March 24, 2011
Last Updated: December 7, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Georgetown University:
pancreas
metastatic
recurrent

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Site
Pancreatic Diseases
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on May 25, 2016