Pancreatic Cancer Clinical Trial
Official title:
A Phase I Dose-Escalating Study of Induction Gemcitabine/Pemetrexed Followed by Pemetrexed and Concurrent Upper Abdominal Radiation Therapy in Patients With Locally Advanced Pancreatic Cancer
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 growth of tumor cells, either by killing the cells or by stopping them from
dividing. Radiation therapy uses high energy x-rays to kill tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of pemetrexed when
given together with radiation therapy in treating patients with locally advanced pancreatic
cancer.
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of pemetrexed disodium when given in combination
with upper abdominal radiotherapy after induction therapy comprising gemcitabine
hydrochloride and pemetrexed disodium followed by consolidation therapy with gemcitabine
hydrochloride in patients with locally advanced pancreatic cancer.
- Determine the quantitative toxicity of this regimen in these patients.
Secondary
- Determine the quantitative and qualitative dose-limiting toxicities of pemetrexed
disodium in combination with upper abdominal radiation therapy.
- Evaluate patterns of failure, response, and survival of these patients at 1 year
OUTLINE: This is an open-label, nonrandomized, dose-escalation study of pemetrexed disodium.
- Induction therapy: Patients receive pemetrexed disodium IV over 10 minutes and
gemcitabine hydrochloride IV over 30 minutes on day 1. Treatment repeats every 14 days
for 3 courses. Approximately 2 weeks later, patients without disease progression proceed
to chemoradiotherapy.
- Chemoradiotherapy: Patients receive pemetrexed disodium IV over 10 minutes on days 1,
15, and 29 and undergo radiotherapy once daily 5 days a week for 5 ½ weeks.
Approximately 2-3 weeks later, patients without disease progression proceed to
consolidation therapy.
Cohorts of 3-9 patients receive escalating doses of pemetrexed disodium during
chemoradiotherapy until the maximum tolerated dose (MTD) is determined. The MTD is defined as
the dose at which ≤ 20% or ≤ 2 of 9 patients experience dose-limiting toxicity.
- Consolidation therapy: Patients receive gemcitabine hydrochloride IV over 30 minutes on
days 1 and 8. Treatment repeats every 21 days for 2 courses in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.
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