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Trial of Single-Dose Intravesical EOquin® as a Surgical Adjuvant Instilled in the Early Postoperative Period in Patients Undergoing TUR-BT

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT00461591
First received: April 16, 2007
Last updated: May 8, 2013
Last verified: May 2013
History of Changes
  Purpose

The purpose of this study is to evaluate the recurrence rate of noninvasive bladder cancer at 2 years in patients with tumor histology Ta, G1-G2 who are randomized to receive TUR-BT plus EOquin® versus those who are randomized to receive TUR-BT plus placebo.


Condition Intervention Phase
Bladder Cancer
 Drug: EOquin®
 Phase 3

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,Phase3 Trial of Single Dose Intravesical EOquin® as a Surgical Adjuvant Instilled in Early Post Operative Period in Patients Undergoing Transurethral Resection for Noninvasive Bladder Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Spectrum Pharmaceuticals, Inc:

Primary Outcome Measures:
  • Recurrence Rate at 2 years [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to Recurrence [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Progression to Higher Stage or Grade [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Number of Recurrences per Patient [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Disease Free Interval [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Disease Free Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 802
Study Start Date: April 2007
Study Completion Date: April 2012
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EOquin® (Apaziquone) Drug: EOquin®
EOquin® for intravesical installation 4mg in 40ml
Other Name: Apaziquone
Placebo Comparator: Placebo Drug: EOquin®
EOquin® for intravesical installation 4mg in 40ml
Other Name: Apaziquone

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® 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 questions must be answered YES)

  • 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 stage 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 questions must be answered NO)

  • Does the patient have more than 4 bladder tumors?
  • Does any single bladder tumor exceed 3.5 cm in diameter?
  • Does the patient have a single, primary (no previous diagnosis of TCC) bladder tumor <0.5 cm?
  • 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 stage 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 10^9/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 a screening hemoglobin < 10 mg/dL, a screening absolute neutrophil count < 1.5 x 10^9/L or a screening creatinine > 2 mg/dL?
  • 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: NCT00461591

  Show 74 Study Locations
Sponsors and Collaborators
Spectrum Pharmaceuticals, Inc
Investigators
Principal Investigator: Mark Soloway, MD University of Miami
  More Information

No publications provided

Responsible Party: Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT00461591     History of Changes
Other Study ID Numbers: SPI-611
Study First Received: April 16, 2007
Last Updated: May 8, 2013
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 May 19, 2013