NCT00410553

Eribulin Mesylate and Gemcitabine Hydrochloride in Treating Patients With Metastatic Solid Tumors or Solid Tumors That Cannot be Removed by Surgery

A Phase I Study of Halichondrin B Analog E7389 in Combination With Gemcitabine in Patients With Refractory or Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Adult Solid Neoplasm
• Recurrent Ovarian Carcinoma
• Recurrent Uterine Corpus Carcinoma
• Stage III Ovarian Cancer AJCC v6 and v7
• Stage III Uterine Corpus Cancer AJCC v7
• Stage IV Ovarian Cancer AJCC v6 and v7
• Stage IV Uterine Corpus Cancer AJCC v7

Interventions

Type	Name	Description
DRUG	Eribulin Mesylate	Given IV
DRUG	Gemcitabine Hydrochloride	Given IV

Timeline

• Start date: 2006-11-14
• Primary completion: 2012-10-24
• Completion: 2012-10-24
• First posted: 2006-12-13
• Last updated: 2018-10-03

Locations

2 sites across 1 country: Canada