Phase 3 Trial of Single-Dose Intravesical EOquin® as a Surgical Adjuvant for Noninvasive Bladder Cancer
Information source: Spectrum Pharmaceuticals, Inc
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bladder Cancer
Intervention: EOquin® (Apaziquone) (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Spectrum Pharmaceuticals, Inc Overall contact:
Shanta Chawla, MD, Phone: (949) 788-6700, Ext: 257, Email: schawla@spectrumpharm.com
Summary
This is a multicenter, randomized, placebo-controlled, double-blind, study. Following
TUR-BT, eligible patients will be randomized to receive either intravesical EOquin®
(Apaziquone) or matching placebo instilled within 6 hours of surgery. Patients will be seen
for a postoperative follow-up exam 21±10 days after the TUR. At this time, the pathology
report will be reviewed. If the histology of the patient's tumor is Ta, G1-G2 (low grade
[WHO/ISUP classification]), then the patient will receive no further treatment and will be
observed cystoscopically every three months through year two for tumor recurrence and
progression. If the histology of the patient's tumor is other than Ta, G1-G2 (low grade
[WHO/ISUP classification]), then the patient will receive further treatment in accordance
with current treatment guidelines, following which the patient will be followed up
cystoscopically every three months through year two for tumor recurrence and progression.
The primary endpoint is to evaluate the recurrence rate at 2 years in randomized patients
with tumor histology Ta, G1-G2 who receive TUR-BT plus EOquin® versus those who receive
TUR-BT plus placebo.
Clinical Details
Official title: A Multicenter, Randomized, Placebo-Controlled, Double-Blind Phase 3 Trial of Single-Dose Intravesical EOquin® as a Surgical Adjuvant Instilled in the Early Postoperative Period in Patients Undergoing Transurethral Resection for Noninvasive Bladder Cancer
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: To evaluate the recurrence rate at 2 years in randomized patients with tumor histology Ta, G1-G2 who receive TUR-BT plus EOquin® versus those who receive TUR-BT plus placebo.
Secondary outcome: To evaluate time to first recurrence in patients with tumor histology Ta, G1-G2 who receive TUR-BT plus EOquin® versus those who receive TUR-BT plus placebo.To evaluate progression to higher stage or grade, number of recurrences per patient, disease free interval, disease free survival and overall survival. To assess the safety of EOquin instilled into the bladder in the early postoperative period.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
All of the following questions must be answered "Yes" in order for the patient to
participate in the study.
1. Has the patient given written informed consent?
2. Is the patient at least 18 years old?
3. Does the patient have transitional cell carcinoma of the bladder with clinically
apparent tumor Ta, grade G1-G2?
4. If the patient is a female of childbearing potential, is she using an
acceptable/effective method of contraception?
5. If the patient is a female of childbearing potential, has she had a negative serum
pregnancy test within the past 14 days?
6. Is the patient willing and able to abide by the protocol?
Exclusion Criteria:
All of the following questions must be answered "No" in order for the patient to
participate in the study.
1. Does the patient have more than 5 bladder tumors?
2. Does any single bladder tumor exceed 3. 5 cm in diameter?
3. Does the patient have a single, primary bladder tumor <0. 5 cm and has no previous
diagnosis of bladder cancer?
4. Has the patient ever received EOquin(r)?
5. Does the patient have, or has the patient ever had, any bladder tumor known to be
other than tumor Ta or grade G1 or G2 (low grade [WHO/ISUP classification])?
6. Does the patient have, or has the patient ever had any bladder tumor with histology
other than transitional cell carcinoma?
7. Does the patient have, or has the patient ever had, CIS?
8. Does the patient have an active urinary tract infection?
9. Does the patient have a bleeding disorder or a screening platelet count < 100 x
109/L?
10. Does the patient have any unstable medical condition that would make it unsafe for
him/her to undergo TUR-BT under general or spinal anesthesia?
11. Does the patient have screening hemoglobin < 10 mg/dL, a screening absolute neutrophil
count < 1. 5 x 109/L?
12. Does the patient have a known immunodeficiency disorder?
13. Has the patient received any investigational treatment within the past 30 days?
14. Is the patient breast feeding?
15. Does the patient have a history of interstitial cystitis?
16. Does the patient have a history of allergy to red color food dye?
17. Has the patient had transitional cell carcinoma of the bladder within the past 4
months?
Locations and Contacts
Shanta Chawla, MD, Phone: (949) 788-6700, Ext: 257, Email: schawla@spectrumpharm.com
Hal J. Bashein, D.O., West Palm Beach, Florida 33407, United States; Recruiting
Sara Fonseca, Phone: 561-848-8700
Hal J Bashein, DO, Principal Investigator
Urology Enterprises, Marietta, Georgia 30060, United States; Recruiting
Becky Hippensteel, Phone: 770-428-6478
Ronald Roper, MD, Principal Investigator
The Urology Center, Slidell, Louisiana 70458, United States; Recruiting
Nikrad Shahnavaz, Phone: 504-952-3162
Mahmoud Daftary, MD, Principal Investigator
Additional Information
Starting date: September 2007
Ending date: April 2010
Last updated: January 28, 2008
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