This phase II trial is studying how well E7389 works as second-line therapy in treating patients with locally advanced, unresectable, or metastatic pancreatic cancer. Drugs used in chemotherapy, such as eribulin mesylate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PRIMARY OBJECTIVE: I. To determine the objective response (complete and partial) to E7389 in patients with locally advanced, unresectable, or metastatic pancreatic adenocarcinoma that progressed after prior gemcitabine hydrochloride-based therapy. SECONDARY OBJECTIVE: I. To determine the antitumor activity of E7389, in terms of median survival, 1-year survival rate, response or stable disease duration, toxicity, and time to disease progression, in these patients. OUTLINE: This is an open-label, multicenter study. Patients receive eribulin mesylate IV on days 1 and 8. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, all patients are followed at 4 weeks. Patients with complete response, partial response, or stable disease are followed every 3 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Given IV
University Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada
Objective Response (Complete and Partial) Evaluated Using RECIST Criteria
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions.
Time frame: Up to 3 years
Stable Disease Rate, Evaluated Using RECIST Criteria
Stable disease is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Time frame: Up to 3 years
Median Survival Time
Estimated using the Kaplan-Meier method.
Time frame: Up to 3 years
Overall Survival
Estimated using the Kaplan-Meier method.
Time frame: At 6 months
Overall Survival
Estimated using the Kaplan-Meier method.
Time frame: At 1 year
Median Time to Disease Progression
Estimated using the Kaplan-Meier method.
Time frame: Duration of time from start of treatment until the criteria for progression are met, assessed up to 3 years
Time to Progression
Estimated using the Kaplan-Meier method. Median time to progression
Time frame: At 6 months
Time to Progression
Estimated using the Kaplan-Meier method.
Time frame: At 1 year
Response Duration
Time frame: From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 3 years
Toxicity
Types of Gr 3 or greater adverse events that are atleast possibly related to study drug
Time frame: All patients will be evaluable for toxicity from the time of their first treatment with E7389.
Objective Stable Disease Rate
Objective stable disease rate Using RECIST
Time frame: Upto 3 years
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