Recurrent Ovarian Carcinoma Clinical Trial
Official title:
A Phase I Study of Halichondrin B Analog E7389 in Combination With Gemcitabine in Patients With Refractory or Advanced Solid Tumors
This phase I trial is studying the side effects and best dose of eribulin mesylate and gemcitabine hydrochloride in treating patients with metastatic or unresectable solid tumors. Drugs used in chemotherapy, such as eribulin mesylate and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
OBJECTIVES:
I. Determine the recommended phase II dose (RPTD) of E7389 (eribulin mesylate) when given in
combination with gemcitabine (gemcitabine hydrochloride) in patients with advanced cancer.
II. Determine the safety, tolerability, and toxicity profile of E7389 and gemcitabine given
in combination.
III. Assess the antitumor activity of E7389 in combination with gemcitabine in patients with
measurable disease.
IV. Determine the pharmacokinetic profile of E7389 and gemcitabine to assess for any possible
interactions between the two agents.
OUTLINE: This is a multicenter, dose-escalation study. Patients receive eribulin mesylate
intravenously (IV) and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 OR
on days 1 and 8.
Courses repeat every 28 or 21 days* in the absence of disease progression or unacceptable
toxicity. Cohorts of 3-6 patients receive escalating doses of eribulin mesylate and
gemcitabine hydrochloride 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 (DLT). NOTE: *If DLT is observed at the first dose level of the 28-day
schedule, subsequent patients are treated on days 1 and 8 of the 21-day schedule; patients
enrolled in the expansion cohort (patients with ovarian or endometrial cancer or
chemotherapy-naive or minimally pre-treated cancer) receive treatment according to the 21-day
schedule.
After completion of study treatment, patients are followed at 4 weeks and then every 3 months
thereafter.
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