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A Phase II Study of the Halichondrin B Analog E7389 as Second Line Therapy for Patients With Locally Advanced Unresectable or Metastatic Pancreatic Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Adenocarcinoma of the Pancreas, Pancreatic Cancer, Recurrent Pancreatic Cancer, Stage II Pancreatic Cancer, Stage III Pancreatic Cancer, Stage IV Pancreatic Cancer

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Trial Information

A Phase II Study of the Halichondrin B Analog E7389 as Second Line Therapy for Patients With Locally Advanced Unresectable or Metastatic Pancreatic Cancer


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.


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).

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response (complete and partial) evaluated using RECIST criteria

Outcome Time Frame:

Up to 3 years

Safety Issue:

No

Principal Investigator

Malcolm Moore

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Health Network-Princess Margaret Hospital

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2009-00173

NCT ID:

NCT00383760

Start Date:

August 2006

Completion Date:

Related Keywords:

  • Adenocarcinoma of the Pancreas
  • Pancreatic Cancer
  • Recurrent Pancreatic Cancer
  • Stage II Pancreatic Cancer
  • Stage III Pancreatic Cancer
  • Stage IV Pancreatic Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Pancreatic Neoplasms

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