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A Phase II Trial of E7389 (Halichondrin B Analog), in Patients With Metastatic Hormone Refractory Prostate Cancer

Phase 2
18 Years
Open (Enrolling)
Adenocarcinoma of the Prostate, Hormone-resistant Prostate Cancer, Recurrent Prostate Cancer, Stage IV Prostate Cancer

Thank you

Trial Information

A Phase II Trial of E7389 (Halichondrin B Analog), in Patients With Metastatic Hormone Refractory Prostate Cancer


I. Determine the number of patients with a > 50% decrease in prostate-specific antigen (PSA)
of at least 4 weeks duration in patients with hormone-refractory metastatic prostate cancer
treated with E7389 (eribulin mesylate).


I. Estimate the measurable disease response in patients with measurable disease.

II. Determine the duration of PSA and measurable disease response. III. Characterize the
safety and tolerability of E7389 in these patients.


Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8.
Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 5 years.

Inclusion Criteria:

- Histologically confirmed adenocarcinoma of the prostate

- Progressive (i.e., new lesions on bone scan or new/enlarging lesions on CT scan) or
stable metastatic disease*

- Patients with bone metastases only (i.e., lacking soft tissue disease) must have a
prostate-specific antigen (PSA) level >= 5 ng/mL within the past 1 week

- Patients with soft tissue metastases and/or visceral disease must have either
measurable disease OR a PSA level >= 5 ng/mL within the past 1 week

- Patients with stable metastases must have a rising PSA level within the past 4 weeks

- Two consecutive rises in PSA, each measurement taken >= 1 week apart

- [Note: *Radiologic evidence of hydronephrosis alone is not considered evidence of
metastatic disease]

- Meets 1 of the following criteria:

- Never received prior chemotherapy/cytotoxic therapy

- Received prior taxane-based regimen

- Received 2 prior cytotoxic chemotherapy regimens including, but not limited to,
prior taxane and anthracyclines

- Previously treated with bilateral orchiectomy or other primary hormonal therapy with
evidence of treatment failure

- Patients who have not undergone bilateral orchiectomy must continue luteinizing
hormone-releasing hormone (LHRH)-agonist therapy (e.g., leuprolide or goserelin) or
LHRH antagonist therapy (e.g. abarelix) while receiving study treatment

- Patients who did not have an orchiectomy must have a testosterone level < 50 ng/dL to
confirm androgen suppression within the past 4 weeks

- ECOG performance status 0-2

- Granulocyte count >= 1,500/mm^3

- Platelet count >= 100,000/mm^3

- Bilirubin =< 1.5 mg/dL

- AST and ALT =< 2.5 times upper limit of normal

- Creatinine =< 2.0 mg/dL OR creatinine clearance >= 40 mL/min

- No active angina pectoris

- No known New York Heart Association class III-IV heart disease

- No myocardial infarction within the past 6 months

- No evidence of ventricular dysrhythmias or other unstable arrhythmia

- Rate-controlled atrial fibrillation is allowed if the patient is asymptomatic from a
cardiac standpoint

- No peripheral neuropathy > grade 2

- No other prior malignancy (excluding nonmelanomatous skin cancer treated with
curative intent) unless the malignancy was treated with curative intent and the
patient has been disease free for >= 5 years

- No serious concurrent medical illness or active infection that would preclude study

- Fertile patients must use effective contraception

- No more than 2 prior chemotherapy regimens for hormone-refractory disease

- A taxane-based regimen, mitoxantrone, or other cytotoxic chemotherapy regimen allowed
provided there is evidence of disease progression

- Treatment with estramustine is not considered a separate cytotoxic regimen

- At least 4 weeks since prior chemotherapy or radiotherapy

- At least 4 weeks since prior flutamide (6 weeks for bicalutamide or nilutamide) and
there is continued evidence of disease progression

- Disease progression after antiandrogen withdrawal must be confirmed by rising PSA
after the required 4-6 week washout period (e.g., PSA level higher than the last PSA
obtained while on antiandrogen therapy)

- More than 4 weeks since prior and no concurrent estrogen, estrogen-like agents (e.g.,
PC-SPES, saw palmetto, or other herbal products that may contain phytoestrogens), or
any other hormonal therapy (including megestrol, finasteride, ketoconazole, or
systemic corticosteroids)

- No prior strontium chloride Sr 89, samarium 153 lexidronam pentasodium, or other

- No concurrent therapeutic anticoagulation with warfarin

- Unfractionated heparin (standard, low-dose, or adjusted dose) or low molecular weight
heparin allowed

- Concurrent bisphosphonates (e.g., pamidronate sodium or zoledronate) allowed provided
the patient has been receiving the bisphosphonate for >= 4 weeks and there is
evidence of disease progression

- No concurrent strong inhibitors or inducers of CYP3A4

- No other concurrent investigational agents

- No other concurrent anticancer therapy, including chemotherapy, gene therapy,
biologic therapy, or immunotherapy

- No concurrent palliative radiotherapy

- No known carcinomatous meningitis or brain metastases

Type of Study:


Study Design:

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

Outcome Measure:

Number of patients with a greater than or equal to 50% decrease in Prostate-specific antigen (PSA) levels

Outcome Time Frame:

Baseline and 4 weeks

Safety Issue:


Principal Investigator

Mark Stein

Investigator Role:

Principal Investigator

Investigator Affiliation:

Eastern Cooperative Oncology Group


United States: Food and Drug Administration

Study ID:




Start Date:

November 2006

Completion Date:

Related Keywords:

  • Adenocarcinoma of the Prostate
  • Hormone-resistant Prostate Cancer
  • Recurrent Prostate Cancer
  • Stage IV Prostate Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Prostatic Neoplasms



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