Eribulin Mesylate as Second-Line Therapy for Locally Advanced, Unresectable, or Metastatic Pancreatic Cancer Patients
Adenocarcinoma of the Pancreas
Recurrent Pancreatic Cancer
Stage II Pancreatic Cancer
Stage III Pancreatic Cancer
Stage IV Pancreatic Cancer
Drug: eribulin mesylate
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of the Halichondrin B Analog E7389 as Second Line Therapy for Patients With Locally Advanced Unresectable or Metastatic Pancreatic Cancer|
- Objective Response (Complete and Partial) Evaluated Using RECIST Criteria [ Time Frame: Up to 3 years ]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.
- Stable Disease Rate, Evaluated Using RECIST Criteria [ Time Frame: Up to 3 years ]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.
- Median Survival Time [ Time Frame: Up to 3 years ]Estimated using the Kaplan-Meier method.
- Overall Survival [ Time Frame: At 6 months ]Estimated using the Kaplan-Meier method.
- Overall Survival [ Time Frame: At 1 year ]Estimated using the Kaplan-Meier method.
- Median Time to Disease Progression [ Time Frame: Duration of time from start of treatment until the criteria for progression are met, assessed up to 3 years ]Estimated using the Kaplan-Meier method.
- Time to Progression [ Time Frame: At 6 months ]
Estimated using the Kaplan-Meier method.
Median time to progression
- Time to Progression [ Time Frame: At 1 year ]Estimated using the Kaplan-Meier method.
- 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 [ Time Frame: All patients will be evaluable for toxicity from the time of their first treatment with E7389. ]Types of Gr 3 or greater adverse events that are atleast possibly related to study drug
- Objective Stable Disease Rate [ Time Frame: Upto 3 years ]Objective stable disease rate Using RECIST
|Study Start Date:||August 2006|
|Study Completion Date:||July 2011|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
Experimental: Treatment (eribulin mesylate)
Patients receive E7389 IV on days 1 and 8.
Drug: eribulin mesylate
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00383760
|University Health Network-Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator:||Malcolm Moore||University Health Network-Princess Margaret Hospital|