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Prostate CancerPhase 2NCT00278993

Evaluating E7389 in Patients With Hormone Refractory Prostate Cancer With Advanced and/or Metastatic Disease Stratified by Prior Chemotherapy

A Phase 2 study testing E7389 in people with Prostate Cancer, run by Eisai Inc. at 18 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a multi-centre, phase II, open-label, two-stage design, single-arm study in patients with hormone-refractory prostate cancer (HRPC) with advanced (rising PSA) and/or metastatic disease and who have had prior anti-androgen therapy. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
E7389
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
18 sitesUnited States
Study dates
Jan 2006to Jan 2008
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males with histologically proven adenocarcinoma of the prostate that has progressed (ie. a minimum of 3 consecutive rises in Prostate Specific Antigen (PSA) (with the last value ≥ 4 ng/mL) taken at least 1 week apart prior to study entry) despite castration or maintenance of castrate-level testosterone (defined as serum testosterone ≤ .50 ng/dL or 1.7 nmol/L), or progressed during non-hormonal chemotherapy.
  • Note: Patients previously treated with an antiandrogen must have disease progression documented after antiandrogen withdrawal. Those who have not undergone orchiectomy must continue medical castration with a gonadotropin-releasing hormone analog. At least 4 weeks must have elapsed between the withdrawal of antiandrogens (6 weeks in the case of nilutamide or bicalutamide and four weeks in the case of flutamide or other secondary hormonal therapy) and enrollment, so as to avoid the possibility of confounding results of the response due to antiandrogen withdrawal.
  • Patients must fulfill one of the following two criteria to be stratified:
  • No prior chemotherapy (except mitoxantrone or estramustine) for advanced and/or metastatic disease as defined in inclusion criteria #1.
  • Failure of no more than one previous chemotherapeutic regimen with tubulin binding agents such as docetaxel.
  • Resolution of all chemotherapy or radiation-related toxicities to less than grade 2 severity, except neuropathy and alopecia
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  • Age ≥ 18 years.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
  • Life expectancy of ≥ 3 months.
  • Adequate renal function as evidenced by serum creatinine ≤ 1.5 times upper limits of normal (ULN) or calculated creatinine clearance ≥ 40 mL/minute (min) per the Cockcroft and Gault formula.
  • Adequate bone marrow function as evidenced by absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L, hemoglobin ≥ 9.0 g/dL (or 5.5 mmol/L), and platelet count ≥ 100 x 10^9/L. Adequate liver function as evidenced by bilirubin ≤ 1.5 x ULN, alanine transaminase (ALT), and aspartate transaminase (AST) ≤ 3 x ULN (in the case of liver metastases ≤ 5 x ULN).
  • Patients willing and able to complete the VAS (Visual Analog Scale).
  • Patients willing and able to comply with the study protocol for the duration of the study.
  • Written informed consent prior to any study-specific screening procedures with the understanding that the patient may withdraw consent at any time without prejudice.

Who cannot join

  • Patients who have received chemotherapy, radiation, or experimental therapy within 4 weeks of start of E7389 treatment
  • Radiation therapy encompassing ≥30% of marrow or treatment with radioactive strontium
  • Patients who require therapeutic anti-coagulant therapy with warfarin or related compounds; (mini dose warfarin or related compounds are permitted).
  • Severe / uncontrolled intercurrent illness/infection.
  • Significant cardiovascular impairment (history of congestive heart failure > NYHA grade II, unstable angina or myocardial infarction within the past six months, or serious cardiac arrhythmia)
  • Patients with organ allografts.
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  • Patients with known immunosuppression such as positive HIV status.
  • Patients who have had a prior malignancy, other than nonmelanoma skin cancer, unless the prior malignancy was diagnosed and definitively treated ≥ 5 years previously with no subsequent evidence of recurrence.
  • Patients with pre-existing neuropathy > Grade 2
  • Patients with brain or subdural metastases are not eligible, except if they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least two weeks before starting treatment with E7389.
  • Patients with meningeal carcinomatosis.
  • Patients with a hypersensitivity to halichondrin B and/or halichondrin B chemical derivative.
  • Patients who participated in a prior E7389 clinical trial.
  • Patients with other significant disease or disorders that, in the Investigator's opinion, would exclude the patient from the study.

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

United States18 sites

  • New York Oncology Hematology, P.C.

    Albany, New York, 12208

  • Minnesota Hematology Oncology

    Burnsville, Minnesota, 33557

  • Missouri Cancer Associates

    Columbia, Missouri, 65201

  • US Oncology

    Dallas, Texas, 75204

  • Mary Crowley Medical Research Center

    Dallas, Texas, 75246

  • Dr. Robert Jotte

    Denver, Colorado, 80218

  • El Paso Cancer Treatment Center

    El Paso, Texas, 79915

  • Texas Oncology PA

    Fort Worth, Texas, 76104

  • Central Indiana Cancer Centers

    Indianapolis, Indiana, 46227

  • Melbourne Internal Medicine Associates

    Melbourne, Florida, 32901

  • St. Luke's Roosevelt Hospital Center

    New York, New York, 10019

  • Columbia University Medical Center

    New York, New York, 10032

  • Virginia Oncology Associates

    Norfolk, Virginia, 23505

  • Ocala Oncology Center PL

    Ocala, Florida, 34474

  • Raleigh Hematology Oncology Associates PL

    Raleigh, North Carolina, 27607

  • Texas Oncology PA

    Tyler, Texas, 75702

  • Tyler Cancer Center

    Tyler, Texas, 75702

  • Deke Slayton Cancer Center

    Webster, Texas, 77598

Other trials in United States

About this study

Official title: A Phase II, Multicenter, Open Label, Two Stage Design Study Evaluating E7389 in Patients With Hormone Refractory Prostate Cancer With Advanced and/or Metastatic Disease Stratified by Prior Chemotherapy

This is a multi-centre, phase II, open-label, two-stage design, single-arm study in patients with hormone-refractory prostate cancer (HRPC) with advanced (rising PSA) and/or metastatic disease and who have had prior anti-androgen therapy. The study will further explore the efficacy of E7389 by enrollment of patients into two strata: those who have had no prior systemic chemotherapy for their disease (except for mitoxantrone and estramustine), and those who failed no more than one previous chemotherapeutic regimen with tubulin-binding agents such as docetaxel.

Conditions
Prostate Cancer
Being tested
E7389
Keywords
Prostate cancer, metastatic disease
Medical subject headings
Prostatic Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • E7389Drug

    Intravenous 1.4 mg/m2 on a 3-week course.

Study groups in NCT00278993
Study groupRoleWhat they receive
1Active comparatorWith stratification
Receives: Drug: E7389

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Prostate Specific Antigen (PSA) Response Rate Based on Bubley Criteria

    Bubley Criteria: Patients must have progressive disease to enter study. For outcomes, PSA response must show at least 50% decrease. Duration of response is the time from >50% decrease from baseline to when there is a 50% decrease in nadir. PSA progressive disease- 25% increase from baseline or increase of 5 ng/mL along with measureable disease Stable disease- decline of less than 50% and not more than 25% increase.

    Measured: 12 months

Secondary outcomes (4)

  1. Duration of Prostate Specific Antigen Response Based on Bubley Criteria

    Duration of response is the time from >50% decrease from baseline to when there is a 50% decrease in nadir.

    Measured: 12 months.

  2. Progression Free Survival

    From the date study treatment was initiated until the earliest date of the first PSA assessment that determined progressive disease, or the death of death if death occurred without disease progression.

    Measured: 12 months

  3. Overall Survival

    Measured: 12 months

  4. Best Objective Tumor Response Rate Based on Response Evaluation Criteria in Solid Tumors (RECIST) Criteria

    Based on Response Evaluation Criteria in Solid Tumors (RECIST), consisting of complete response (CR) plus partial response (PR). Defined as the best response from the start of treatment until disease progression or recurrence. Lesions measured by computed tomography (CT) scan and magnetic resonance imaging (MRI). Objective response rate: complete response (CR-disappearance of all lesions)+ partial response (PR-30% decrease in lesion diameter), Progressive Disease (PD-20% increase in lesion diameter), stable disease (SD-neither shrinkage nor increase of lesions).

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2006 (estimated)
  2. Study startJan 2006
  3. Primary completionJan 2008
  4. Study completionJan 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00278993
Sponsor's protocol ID
E7389-G000-204
Other IDs
2005-004271-37, 2005
Status last verified
Apr 2012
First submitted
17 Jan 2006
Last updated
14 Jul 2014

Publications

  • de Liano AG, Reig O, Mellado B, Martin C, Rull EU, Maroto JP. Prognostic and predictive value of plasma testosterone levels in patients receiving first-line chemotherapy for metastatic castrate-resistant prostate cancer. Br J Cancer. 2014 Apr 29;110(9):2201-8. doi: 10.1038/bjc.2014.189. Epub 2014 Apr 10.

    PubMed 24722180

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing E7389 in people with Prostate Cancer, run by Eisai Inc. at 18 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Prostate Specific Antigen (PSA) Response Rate Based on Bubley Criteria (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00278993, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2014.

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