Phase 3 Trial of Single-Dose Intravesical EOquin® as a Surgical Adjuvant for Noninvasive Bladder Cancer - Full Text View

Sponsor:	Spectrum Pharmaceuticals, Inc
Information provided by:	Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:	NCT00598806

Purpose

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.

Condition	Intervention	Phase
Bladder Cancer	Drug: EOquin® (Apaziquone)	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: bladder cancer

MedlinePlus related topics: Bladder Cancer Cancer

Drug Information available for: Apaziquone

U.S. FDA Resources

Further study details as provided by Spectrum Pharmaceuticals, Inc:

Primary Outcome Measures:

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. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
To evaluate progression to higher stage or grade, number of recurrences per patient, disease free interval, disease free survival and overall survival. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
To assess the safety of EOquin instilled into the bladder in the early postoperative period. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	800
Study Start Date:	September 2007
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: 1 Placebo	Drug: EOquin® (Apaziquone) 4mg in 40 mL for intravesical instillation Other Name: EOquin®
Experimental: 2 EOquin® (Apaziquone)	Drug: EOquin® (Apaziquone) 4mg in 40 mL for intravesical instillation Other Name: EOquin®

Detailed Description:

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.

Eligibility

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

Criteria

Inclusion Criteria:

All of the following questions must be answered "Yes" in order for the patient to participate in the study.

Has the patient given written informed consent?
Is the patient at least 18 years old?
Does the patient have transitional cell carcinoma of the bladder with clinically apparent tumor Ta, grade G1-G2?
If the patient is a female of childbearing potential, is she using an acceptable/effective method of contraception?
If the patient is a female of childbearing potential, has she had a negative serum pregnancy test within the past 14 days?
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.

Does the patient have more than 5 bladder tumors?
Does any single bladder tumor exceed 3.5 cm in diameter?
Does the patient have a single, primary bladder tumor <0.5 cm and has no previous diagnosis of bladder cancer?
Has the patient ever received EOquin(r)?
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])?
Does the patient have, or has the patient ever had any bladder tumor with histology other than transitional cell carcinoma?
Does the patient have, or has the patient ever had, CIS?
Does the patient have an active urinary tract infection?
Does the patient have a bleeding disorder or a screening platelet count < 100 x 109/L?
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?
Does the patient have screening hemoglobin < 10 mg/dL, a screening absolute neutrophil count < 1.5 x 109/L?
Does the patient have a known immunodeficiency disorder?
Has the patient received any investigational treatment within the past 30 days?
Is the patient breast feeding?
Does the patient have a history of interstitial cystitis?
Does the patient have a history of allergy to red color food dye?
Has the patient had transitional cell carcinoma of the bladder within the past 4 months?

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00598806

Show 77 Study Locations

Sponsors and Collaborators

Spectrum Pharmaceuticals, Inc

Investigators

Principal Investigator:

Shanta Chawla, MD

Spectrum Pharmaceuticals, Inc

More Information

No publications provided

Responsible Party:	Spectrum Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00598806 History of Changes
Other Study ID Numbers:	SPI-612
Study First Received:	January 11, 2008
Last Updated:	March 11, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Spectrum Pharmaceuticals, Inc:

Noninvasive Bladder Cancer

Additional relevant MeSH terms:

Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases

Urologic Diseases
Apaziquone
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012