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Keep this study
Lead
Georgetown University
With
Eli Lilly and Company
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
