Status:
TERMINATED
Pemetrexed, Gemcitabine, and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE1
Brief Summary
RATIONALE: Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for their growth. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the gr...
Detailed Description
OBJECTIVES: Primary * Determine the maximum tolerated dose of pemetrexed disodium when given in combination with upper abdominal radiotherapy after induction therapy comprising gemcitabine hydrochlo...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed carcinoma arising from the pancreas
- Stage II or III disease, meeting 1 of the following criteria:
- Nonresectable disease
- Potentially resectable disease
- Resectable disease
- Stage IV disease with symptomatic back pain requiring palliation allowed at the discretion of the principal investigator
- Measurable, evaluable, or nonmeasurable disease
- No neuroendocrine tumor of the pancreas
- No documented brain metastasis
- No clinically significant pleural or peritoneal effusions that cannot be drained
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Life expectancy ≥ 12 weeks
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 9 g/dL
- Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 3 times ULN (5 times ULN if liver has tumor involvement)
- AST and ALT ≤ 3 times ULN (5 times ULN if liver has tumor involvement)
- Creatinine clearance ≥ 45 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after completion of study treatment
- No active infection
- No serious systemic disorders that would preclude study treatment
- No significant cardiovascular disease in the form of abnormal electrocardiogram coupled with clinical features of recent or recurrent cardiac disease (including myocardial infarction, angina, or hypertension)
- PRIOR CONCURRENT THERAPY:
- More than 4 weeks since prior investigational agents
- No prior chemotherapy for pancreatic cancer
- Must be able to discontinue aspirin, dexamethasone, and other nonsteroidal anti-inflammatory agents for 2 days before, the day of, and 2 days after pemetrexed disodium dose (5 days before for long-acting agents such as piroxicam)
- Must be able and willing to take folic acid and cyanocobalamin (vitamin B12) supplementation
Exclusion
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00310050
Start Date
October 1 2005
End Date
May 1 2008
Last Update
November 30 2018
Active Locations (1)
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1
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096