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

NCT00383760 | Completed Phase 2 Results DMC

• 4 other identifiers: NCI-2009-00173PHL-049CDR0000502291N01CM62203
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Adenocarcinoma of the Pancreas; Pancreatic Cancer; Recurrent Pancreatic Cancer; Stage II Pancreatic Cancer; Stage III Pancreatic Cancer; Stage IV Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 3 years

Secondary Outcomes (10)

• Stable Disease Rate, Evaluated Using RECIST Criteria

  Up to 3 years

• Median Survival Time

  Up to 3 years

• Overall Survival

  At 6 months

• Overall Survival

  At 1 year

• Median Time to Disease Progression

  Duration of time from start of treatment until the criteria for progression are met, assessed up to 3 years

Study Arms (1)

Treatment (eribulin mesylate)

EXPERIMENTAL

Patients receive E7389 IV on days 1 and 8.

Drug: eribulin mesylate

Interventions

eribulin mesylate DRUG

Given IV

Also known as: B1939, E7389, ER-086526, halichrondrin B analog

Treatment (eribulin mesylate)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

University Health Network-Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

eribulin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Dr. Malcolm Moore
• Organization: Princess Margaret Cancer Centre

malcolm.moore@uhn.ca

416-945-2263

Study Officials

• Malcolm Moore

  University Health Network-Princess Margaret Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2006
• First Posted: October 3, 2006
• Study Start: August 1, 2006
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: October 20, 2017
• Results First Posted: December 9, 2016

Record last verified: 2017-09

Locations

CA (1)