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

NCT00278993 | Completed Phase 2 Results

• 2 other identifiers: E7389-G000-2042005-004271-37
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 18

Brief 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. 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

Keywords

Prostate cancer; metastatic disease

Outcome Measures

Primary Outcomes (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.

  12 months

Secondary Outcomes (4)

• Duration of Prostate Specific Antigen Response Based on Bubley Criteria

  12 months.

• Progression Free Survival

  12 months

• Overall Survival

  12 months

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

  12 months

Study Arms (1)

1

ACTIVE COMPARATOR

With stratification

Drug: E7389

Interventions

E7389 DRUG

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

1

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (18)

Dr. Robert Jotte

Denver, Colorado, 80218, United States

Location

Melbourne Internal Medicine Associates

Melbourne, Florida, 32901, United States

Location

Ocala Oncology Center PL

Ocala, Florida, 34474, United States

Location

Central Indiana Cancer Centers

Indianapolis, Indiana, 46227, United States

Location

Minnesota Hematology Oncology

Burnsville, Minnesota, 33557, United States

Location

Missouri Cancer Associates

Columbia, Missouri, 65201, United States

Location

New York Oncology Hematology, P.C.

Albany, New York, 12208, United States

Location

St. Luke's Roosevelt Hospital Center

New York, New York, 10019, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Raleigh Hematology Oncology Associates PL

Raleigh, North Carolina, 27607, United States

Location

US Oncology

Dallas, Texas, 75204, United States

Location

Mary Crowley Medical Research Center

Dallas, Texas, 75246, United States

Location

El Paso Cancer Treatment Center

El Paso, Texas, 79915, United States

Location

Texas Oncology PA

Fort Worth, Texas, 76104, United States

Location

Texas Oncology PA

Tyler, Texas, 75702, United States

Location

Tyler Cancer Center

Tyler, Texas, 75702, United States

Location

Deke Slayton Cancer Center

Webster, Texas, 77598, United States

Location

Virginia Oncology Associates

Norfolk, Virginia, 23505, United States

Location

Related Publications (1)

• 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.

  PMID: 24722180 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasm Metastasis

Interventions

eribulin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Eisai Inc.
• Organization: Eisai Call Center

888-422-4743

Study Officials

• Asha Das

  Eisai Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2006
• First Posted: January 19, 2006
• Study Start: January 1, 2006
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: July 14, 2014
• Results First Posted: May 15, 2012

Record last verified: 2012-04

Locations

US (18)