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E7389 in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by National Cancer Institute (NCI).   Recruitment status was  Active, not recruiting

First Received on June 13, 2006.   Last Updated on August 7, 2009   History of Changes
Sponsor: Eastern Cooperative Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00337077
  Purpose

RATIONALE: Drugs used in chemotherapy, such as E7389, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well E7389 works in treating patients with metastatic prostate cancer that did not respond to hormone therapy.


Condition Intervention Phase
Prostate Cancer
Drug: eribulin mesylate
Phase II

Study Type: Interventional
Study Design: 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:
  • Prostate-specific antigen response (PSA) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measurable disease response [ Designated as safety issue: No ]
  • Overall response [ Designated as safety issue: No ]

Estimated Enrollment: 129
Study Start Date: November 2006
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • 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.

Secondary

  • Estimate the measurable disease response in patients with measurable disease.
  • Determine the duration of PSA and measurable disease response.
  • Characterize the safety and tolerability of E7389 in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to prior chemotherapy (no prior chemotherapy vs prior taxane only vs 2 prior cytotoxic chemotherapy regimens).

Patients receive E7389 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.

PROJECTED ACCRUAL: A total of 129 patients will be accrued for this study.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • 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
  • No known carcinomatous meningitis or brain metastases

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Granulocyte count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • 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

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • 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
  • Up to 2 prior noncytotoxic experimental therapies for metastatic disease allowed provided it was given ≥ 4 weeks ago and there is evidence of disease progression
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00337077

  Show 155 Study Locations
Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Study Chair: Mark Stein, MD Cancer Institute of New Jersey
Investigator: Gary R. Hudes, MD Fox Chase Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Robert L. Comis, ECOG Group Chair's Office
ClinicalTrials.gov Identifier: NCT00337077     History of Changes
Other Study ID Numbers: CDR0000482413, ECOG-E5805
Study First Received: June 13, 2006
Last Updated: August 7, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
recurrent prostate cancer
stage IV prostate cancer
adenocarcinoma of the prostate

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on February 09, 2012