Status:
TERMINATED
Study of Pemetrexed for Second-Line Pancreas Cancer
Lead Sponsor:
Georgetown University
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Pancreas Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 pemetrex...
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 wi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00864513
Start Date
October 1 2007
End Date
July 1 2009
Last Update
December 8 2015
Active Locations (1)
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1
Georgetown University Hospital/Lombardi Cancer Center
Washington D.C., District of Columbia, United States, 20007