Study of Pemetrexed for Second-Line Pancreas Cancer

• 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 ]

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.

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