Lymphoma Clinical Trial
Official title:
Phase I/II Trial of Gemcitabine/Pemetrexed Combination in Patients With Advanced Cutaneous T-Cell Lymphoma
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop
the growth of cancer cells, either by killing the cells or by stopping them from dividing.
Pemetrexed disodium may stop the growth of cancer cells by blocking some of the enzymes
needed for cell growth. Giving gemcitabine together with pemetrexed disodium may kill more
cancer cells.
PURPOSE: This was planned as a phase I/II trial studying the side effects and determining the
best dose of gemcitabine hydrochloride when given together with pemetrexed disodium.
Unfortunately, due to a lack of funding, the phase II portion was never conducted.
OBJECTIVES:
1. Determine the safety and tolerability of gemcitabine hydrochloride and pemetrexed
disodium in patients with advanced mycosis fungoides or Sézary syndrome. (Phase I)
2. Determine the maximum tolerated dose of gemcitabine hydrochloride when administered with
pemetrexed disodium in these patients. (Phase I)
OUTLINE: This is a phase I, dose-escalation study of gemcitabine hydrochloride. Originally,
this was designed to be followed by a phase II portion to determine the efficacy in this
population. Unfortunately, due to a lack of funding, the phase II portion was never
conducted.
During Phase I: Patients receive pemetrexed disodium IV over 10 minutes and gemcitabine
hydrochloride IV on days 1 and 15. Treatment repeats every 28 days in the absence of disease
progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of gemcitabine hydrochloride until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which ≥ 2 of 6
patients experience dose-limiting toxicity.
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