Status:
COMPLETED
Eribulin Mesylate as Second-Line Therapy for Locally Advanced, Unresectable, or Metastatic Pancreatic Cancer Patients
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adenocarcinoma of the Pancreas
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
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 afte...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00383760
Start Date
August 1 2006
End Date
July 1 2011
Last Update
October 20 2017
Active Locations (1)
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1
University Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9