Study of Pemetrexed for Second-Line Pancreas Cancer
| Status: | Terminated |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | October 2007 |
| End Date: | July 2009 |
A Phase II Study of Pemetrexed as Second-Line Treatment in Patients With Pancreatic Cancer Progressing Despite Therapy With Gemcitabine
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.
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.
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
- 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
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