NCT00141531

Brief Summary

A non-randomized, open-label phase II study to explore the feasibility, time to recurrence, duration of response and safety of the adjuvant intravesical instillation of EOquin (apaziquone) in patients with high-risk superficial bladder tumors, and the response and duration of response in patients with carcinoma in situ of the bladder.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2005

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2005

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

June 14, 2012

Status Verified

June 1, 2012

Enrollment Period

4.4 years

First QC Date

August 30, 2005

Last Update Submit

June 13, 2012

Conditions

Bladder Neoplasms

Keywords

Bladder cancerSuperficialCarcinoma in situIntravesical instillationChemotherapyAdjuvant

Outcome Measures

Primary Outcomes (1)

  • Time to progression / Duration of remission following transurethral resection of superficial bladder cancer

    18 months

Secondary Outcomes (2)

  • Additional safety data

    18 months

  • Rate of upstaging on recurrence

    18 months

Study Arms (1)

Apaziquone

ACTIVE COMPARATOR
Drug: Apaziquone

Interventions

ApaziquoneDRUG

Apaziquone (EOquinTM) 4 mg/40 mL was administered by intravesical instillation once a week for 6 consecutive weeks. In addition, patients with CIS were to receive further maintenance therapy of 3 weekly apaziquone (EOquinTM) instillations at 3, 6, and 12 months from the date of histological diagnosis.

Also known as: EOquin
Apaziquone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Patients with high risk superficial bladder cancer according to EAU criteria defined as:
  • pT1 and/or Grade 2b-3, or multiple and highly recurrent
  • histologically confirmed carcinoma in situ 2. All visible lesions must be completely removed by transurethral resection (TUR) at entry to the study 3. Normal bimanual examination under anesthesia (no palpable masses) 4. Absence of upper urinary tract tumor confirmed by intravenous pyelography (IVP) or CT scan or retrograde urogram within 6 months from the beginning of treatment 5. Patient with ZUBROD-ECOG-WHO performance status of 0-2 (see Appendix 2) 6. Over 18 years of age 7. Patients must be fully informed of the investigational nature of the study and signed written informed consent must be obtained prior to any study specific investigations.

You may not qualify if:

  • Patients having muscle-invasive disease (T2 or greater)
  • Prior intravesical treatment (chemotherapy or immunotherapy) within the last 3 months
  • Patients with existing urinary tract infection or recurrent severe bacterial cystitis
  • Patients with urogenital tumors with histology other than transitional cell carcinoma (i.e., squamous cell or adenocarcinoma) or with transitional carcinoma involving the upper tract or the prostatic urethra
  • Patients with active, uncontrolled impairment of the renal, hepatobiliary, cardiovascular, gastrointestinal, urogenital, neurologic or hematopoietic systems which, in the opinion of the investigator, would predispose to the development of complications from the administration of intravesical therapy and or general anesthesia
  • Patients who, in the opinion of the investigator, cannot tolerate intravesical administration or intravesical surgical manipulation (cystoscopy, biopsy) due to the presence of concomitant serious illness (i.e. uncontrolled cardiac or respiratory disorders)
  • Women who are pregnant or lactating. Individuals of reproductive potential may not participate unless agreeing to use an effective contraceptive method for themselves and/or their sexual partner

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Radboud University Hospital

Nijmegen, Netherlands

Location

MeSH Terms

Conditions

Urinary Bladder NeoplasmsCarcinoma in Situ

Interventions

apaziquone

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Alfred Witjes, MD, Prof.

    Urology Division, St Radboud University Hospital, Nijmegen, the Netherlands

    STUDY CHAIR

  • Kees Hendricksen, MD

    St Radboud University Hospital, Nijmegen, the Netherlands

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

August 30, 2005

First Posted

September 1, 2005

Study Start

July 1, 2005

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

June 14, 2012

Record last verified: 2012-06

Locations

NL(1)