Eribulin Mesylate as Second-Line Therapy for Locally Advanced, Unresectable, or Metastatic Pancreatic Cancer Patients
|Adenocarcinoma of the Pancreas Pancreatic Cancer Recurrent Pancreatic Cancer Stage II Pancreatic Cancer Stage III Pancreatic Cancer Stage IV Pancreatic Cancer||Drug: eribulin mesylate||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (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|