Liver Cancer Clinical Trial
Official title:
Phase I/II Trial Of Gemcitabine And ALIMTA In Patients With Measurable Or Evaluable, Unresectable Or Metastatic Biliary Tract Carcinoma (Intrahepatic, Extrahepatic, Ampulla Or Vater) And Gallbladder Carcinoma
RATIONALE: Drugs used in chemotherapy such as gemcitabine work in different ways to stop
tumor cells from dividing so they stop growing or die. Pemetrexed disodium may stop the
growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Combining
gemcitabine with pemetrexed disodium may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of gemcitabine
when given together with pemetrexed disodium to see how well it works in treating patients
with unresectable or metastatic biliary tract or gallbladder cancer.
OBJECTIVES:
- Determine the maximum tolerated dose of gemcitabine when administered with pemetrexed
disodium in patients with unresectable or metastatic biliary tract or gallbladder
cancer. (Phase I closed to accrual as of Oct. 2005.)
- Determine the 6-month survival rate of patients treated with this regimen.
- Determine the best objective tumor response rate and duration of best objective tumor
response in patients treated with this regimen.
- Determine the time to progression and overall survival of patients treated with this
regimen.
- Determine the toxic effects of this regimen in these patients.
- Determine the individual patient variation in toxicity of and/or response to this
regimen due to genetic differences in proteins involved in drug response in these
patients.
OUTLINE: This is a multicenter phase I dose-escalation study of gemcitabine followed by a
phase II study.
- Phase I: Patients receive pemetrexed disodium IV over 10 minutes and gemcitabine IV
over 30 minutes on days 1 and 15. Courses repeat every 28 days in the absence of
disease progression or unacceptable toxicity (phase I closed to accrual as of October
2005).
Cohorts of 3-6 patients receive escalating doses of gemcitabine until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
of 6 patients experience dose-limiting toxicity.
- Phase II: Patients receive pemetrexed disodium as in phase I and gemcitabine at the
recommended phase II dose.
Patients are followed every 3 months for 1 year and then every 6 months for 4 years.
PROJECTED ACCRUAL: A total of 85 patients will be accrued for this study.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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