Eribulin Mesylate in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00337077
First received: June 13, 2006
Last updated: December 6, 2013
Last verified: December 2013
  Purpose

This phase II trial is studying how well eribulin mesylate works in treating patients with metastatic prostate cancer that did not respond to hormone therapy. 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 Prostate
Hormone-resistant Prostate Cancer
Recurrent Prostate Cancer
Stage IV Prostate Cancer
Drug: eribulin mesylate
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of E7389 (Halichondrin B Analog), in Patients With Metastatic Hormone Refractory Prostate Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Number of patients with a greater than or equal to 50% decrease in Prostate-specific antigen (PSA) levels [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measurable disease response assessed by Response Evaluation Criteria for Solid Tumors (RECIST) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Overall response [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: From the time that measurement criteria are met for complete or partial response (whichever status is recorded first) until the first date that recurrent or progressive disease is objectively documented, up to 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 129
Study Start Date: November 2006
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (eribulin mesylate)
Patients receive eribulin mesylate IV over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Drug: eribulin mesylate
Given IV
Other Names:
  • B1939
  • E7389
  • ER-086526
  • halichrondrin B analog

Detailed Description:

PRIMARY OBJECTIVES:

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).

SECONDARY OBJECTIVES:

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.

OUTLINE:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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 treatment
  • 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 radioisotopes
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00337077

  Show 147 Study Locations
Sponsors and Collaborators
Investigators
Principal Investigator: Mark Stein Eastern Cooperative Oncology Group
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00337077     History of Changes
Other Study ID Numbers: NCI-2009-00566, NCI-2009-00566, CDR0000482413, E5805, E5805, U10CA021115
Study First Received: June 13, 2006
Last Updated: December 6, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Adenocarcinoma
Prostatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 15, 2014