Study of Pemetrexed for Second-Line Pancreas Cancer
Primary Purpose
Pancreas Cancer
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
pemetrexed
Sponsored by
About this trial
This is an interventional treatment trial for Pancreas Cancer focused on measuring pancreas, metastatic, recurrent
Eligibility 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
Sites / Locations
- Georgetown University Hospital/Lombardi Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
chemotherapy
Arm Description
pemetrexed
Outcomes
Primary Outcome Measures
Progression-free Survival
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
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
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
Toxicity by National Cancer Institute Common Toxicity Criteria Adverse Event Version 3.0
Full Information
NCT ID
NCT00864513
First Posted
March 17, 2009
Last Updated
December 7, 2015
Sponsor
Georgetown University
Collaborators
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT00864513
Brief Title
Study of Pemetrexed for Second-Line Pancreas Cancer
Official Title
A Phase II Study of Pemetrexed as Second-Line Treatment in Patients With Pancreatic Cancer Progressing Despite Therapy With Gemcitabine
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Terminated
Why Stopped
At interim analysis the study did not meet the response criteria to continue
Study Start Date
October 2007 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Georgetown University
Collaborators
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreas Cancer
Keywords
pancreas, metastatic, recurrent
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
chemotherapy
Arm Type
Experimental
Arm Description
pemetrexed
Intervention Type
Drug
Intervention Name(s)
pemetrexed
Other Intervention Name(s)
Alimta, LY231514, NSC# 698037
Intervention Description
pemetrexed 500 mg/m2 IV day 1 of each 21 day cycle until disease progression or unacceptable toxicity for a maximum of 8 cycles
Primary Outcome Measure Information:
Title
Progression-free Survival
Description
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.
Time Frame
6 months after last patient enrolled
Secondary Outcome Measure Information:
Title
Objective Response
Description
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
Time Frame
Within two months of the completion of the last dose of chemotherapy
Title
CA 19-9 Response
Description
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.
Time Frame
Within two months of the last dose of chemotherapy
Title
Number of Participants With Adverse Events
Description
Toxicity by National Cancer Institute Common Toxicity Criteria Adverse Event Version 3.0
Time Frame
30 days after last dose of study drug
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jimmy J Hwang, M.D.
Organizational Affiliation
Georgetown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Georgetown University Hospital/Lombardi Cancer Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of Pemetrexed for Second-Line Pancreas Cancer
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