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

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: April 11, 2013
Last verified: April 2013
  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: Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Stable disease rate, evaluated using RECIST criteria [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Estimated using the Kaplan-Meier method.

  • Overall survival [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
    Estimated using the Kaplan-Meier method.

  • Overall survival [ Time Frame: At 1 year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Estimated using the Kaplan-Meier method.

  • Time to progression [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
    Estimated using the Kaplan-Meier method.

  • Time to progression [ Time Frame: At 1 year ] [ Designated as safety issue: No ]
    Estimated using the Kaplan-Meier method.

  • Objective stable disease rate [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Toxicity, graded using the NCI common toxicity criteria version 3.0 [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]

Enrollment: 37
Study Start Date: August 2006
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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%.
  • Life expectancy >= 3 months.
  • Bilirubin =< 1.5 times upper limit of normal (ULN).
  • AST and ALT =< 2.5 times ULN
  • Creatinine normal or creatinine clearance >= 60 mL/min
  • Not pregnant or nursing.
  • Negative pregnancy test.
  • No other active malignancies within the past 5 years except for cervical carcinoma in situ or nonmelanomatous skin cancer.
  • Recovered from prior therapy.
  • At least 4 weeks since prior angiogenesis inhibitors and/or epidermal growth factor receptors.
  • At least 4 weeks since prior major surgery.
  • At least 4 weeks since prior fluorouracil or gemcitabine hydrochloride given concurrently with radiotherapy as a radiosensitizer.
  • At least 4 weeks since prior radiotherapy.
  • No concurrent inhibitors or inducers of CYP3A4.
  • Concurrent CYP3A4 substrates allowed.
  • No other concurrent investigational agents.
  • No concurrent combination antiretroviral therapy for HIV-positive patients.
  • No other concurrent anticancer agents or therapies.
  • No concurrent colony-stimulating factors during the first course of study therapy.
  • Histologically or cytologically confirmed pancreatic adenocarcinoma that is locally advanced, unresectable or metastatic. Disease progression must be documented if patient underwent prior radiotherapy to local disease.
  • Measurable disease, defined as >= 1 unidimesionally measurable lesion >= 20 mm by conventional techniques or >= 10 mm by spiral CT scan.
  • Evidence of disease progression after treatment with 1 line of prior gemcitabine hydrochloride-based systemic therapy (single-agent or combination therapy) for locally advanced or metastatic disease.
  • No known brain metastases.
  • Fertile patients must use effective contraception.
  • No history of allergic reactions attributed to compounds of similar chemical or biological composition to E7389.
  • No uncontrolled intercurrent illness including, but not limited to, any of the following: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric illness or social situations that would preclude study compliance.
  • WBC >= 3,000/mm^3
  • Absolute neutrophil count >= 1,500/mm^3
  • Platelet count >= 100,000/mm^3
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C).
  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
Investigators
Principal Investigator: Malcolm Moore University Health Network-Princess Margaret Hospital
  More Information

No publications provided

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
Last Updated: April 11, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 23, 2014