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Eribulin Mesylate as Second-Line Therapy for Locally Advanced, Unresectable, or Metastatic Pancreatic Cancer Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00383760
First received: September 29, 2006
Last updated: December 14, 2016
Last verified: December 2016
  Purpose
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.

Condition Intervention Phase
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 Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 15
Study Start Date: August 2006
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (eribulin mesylate)
Patients receive E7389 IV on days 1 and 8.
Drug: eribulin mesylate
Given IV
Other Names:
  • B1939
  • E7389
  • ER-086526
  • halichrondrin B analog

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically/cytologically confirmed pancreatic carcinoma (locally advanced, unresectable or metastatic)
  • measurable disease (at least 1 lesion accurately measured in at least 1 dimension (longest diameter as >20mm with conventional techniques or >10mm with spiral CT scan)
  • >=4 weeks from any major surgery
  • Up to 1 prior line of gemcitabine based systemic therapy (single agent/combination therapy) for locally advanced/metastatic disease with evidence of disease progression. Prior therapy with inhibitors of angiogenesis and/or the epidermal growth factor receptor permitted. Last chemotherapy dose >=4 weeks prior to randomization.
  • May have received prior 5FU (+/- folinic acid)/gemcitabine given concurrently with radiation as a "radiation sensitizer". Last chemotherapy dose >=4 weeks prior to randomization.
  • Prior radiation treatment >=4 weeks prior to randomization
  • Age >18 years.
  • Life expectancy >=3 months
  • ECOG< 2(Karnofsky-60%)
  • leukocytes>3,000/mcL
  • absolute neutrophil count>1,500/mcL
  • platelets>100,000/mcL
  • total bilirubin < 1.5 UNL
  • AST/ALT≤2.5x institutional ULN
  • creatinine within institution limits OR creatinine clearance>60mL/min/1.73m2 for patients with creatinine levels above institution limits
  • concurrent use of inhibitors/inducers of CYP3A4 are prohibited during the study treatment period
  • effects of E7389 on developing human fetus are unknown. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
  • Ability to understand/willingness to sign written informed consent

Exclusion Criteria:

  • chemotherapy/radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
  • May not be receiving other investigational agents
  • Known brain metastases
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to E7389
  • Uncontrolled intercurrent illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study
  • Pregnant women excluded because E7389 is an antitubulin agent with the potential for teratogenic/abortifacient effects
  • HIV-positive patients on combination antiretroviral therapy are ineligible because of potential for p PK interactions with E7389
  • Other active malignancies in past 5 years except for cervical carcinoma in situ and non-melanomatous skin cancer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00383760

Locations
Canada, Ontario
University Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Malcolm Moore University Health Network-Princess Margaret Hospital
  More Information

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00383760     History of Changes
Other Study ID Numbers: NCI-2009-00173  PHL-049  CDR0000502291  N01CM62203 
Study First Received: September 29, 2006
Results First Received: April 18, 2014
Last Updated: December 14, 2016

Additional relevant MeSH terms:
Pancreatic Neoplasms
Adenocarcinoma
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on February 23, 2017