AzTrials
AzTrials

Bladder NeoplasmsPhase 2NCT00141531

Phase II Trial of EOquin in High-risk Superficial Bladder Cancer

A Phase 2 study testing Apaziquone in people with Bladder Neoplasms, run by Spectrum Pharmaceuticals, Inc at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bladder Neoplasms
What is being tested?
Apaziquone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
1 siteNetherlands
Study dates
Jul 2005to Dec 2009
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. 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.

Who cannot join

  • 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 history of other primary malignancy (other than squamous or basal cell skin cancers or cone biopsied Cis of the uterine cervix or prostate carcinoma treated curatively with normal PSA values at inclusion) in the last five years
  • 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

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • St Radboud University Hospital

    Nijmegen

Other trials in Netherlands

About this study

Official title: Phase II Study of Intravesical Instillation of EOQUIN™ in High Risk Superficial Bladder Cancer

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.

Read the detailed description

Endpoints: Time to recurrence, duration of response and safety

Number of Patients: 53 patients

Study Design: Non-randomized, open-label study.

Key Inclusion Criteria: High-risk patients according to EAU criteria defined as

  • pT1 and/or Grade 2b-3, or multiple and highly recurrent
  • histologically confirmed carcinoma in situ (CIS)

Key Exclusion Criteria:

pTa Grade 1 or pT1 Grade 1 tumors, existing urinary tract infection or recurrent severe bacterial cystitis; those who cannot tolerate intravesical administration or intravesical surgical manipulation due to the presence of concomitant serious illness; no prior intravesical chemotherapy or immunotherapy in the last three months; no prior EOquin treatment (intravenous or intravesical) in last 12 months.

Study Treatment:

All patients will receive intravesical instillation of EOquin™ 4-mg/40 mL instillate once a week for six consecutive weeks

Patient with carcinoma in situ (CIS) will receive further maintenance therapy with 3 consecutive weekly EOquin instillations at the following time points: 3, 6, 12, 18, and 24 months from the date of TUR. At 3-month follow up visit patients will undergo cystoscopic bladder biopsy and urine cytology. If bladder biopsy is negative at 3-month visit, the follow up during the remaining visits will be by cystoscopy and urine cytology only, which will be done prior to the start of maintenance therapy. In case of positive cytology presence of CIS has to be confirmed histologically with biopsies.

At 6 months follow-up, if biopsies are positive for CIS, no further maintenance therapy will be given; patient will be taken off-study.

Duration of Patient Participation:

Intravesical instillation of EOquin™ will be given once a week for six consecutive weeks. All patients will have follow-up evaluations carried out at 3, 6, 9, 12, 15 and 18 months from the TUR date or until progressive disease is observed. In case of recurrence, patients will go off the study and further treatment will be at the investigator's discretion.

Off Study:

Patients will be taken off the study:

  • Upon first recurrence and or progression
  • Persistent CIS at 6 months follow up
  • Recurrent CIS after biopsy proven complete response
Being tested
Apaziquone
Keywords
Bladder cancer, Superficial, Carcinoma in situ, Intravesical instillation, Chemotherapy, Adjuvant
Medical subject headings
Urinary Bladder Neoplasms, Carcinoma in Situ

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ApaziquoneDrug

    Also called EOquin

    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.

Study groups in NCT00141531
Study groupRoleWhat they receive
ApaziquoneActive comparatorNot described
Receives: Drug: Apaziquone

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 18 months

Secondary outcomes (2)

  1. Additional safety data

    Measured: 18 months

  2. Rate of upstaging on recurrence

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2005 (estimated)
  2. Study startJul 2005
  3. Primary completionDec 2009
  4. Study completionDec 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00141531
Sponsor's protocol ID
SPI 05-003
Other IDs
503
Status last verified
Jun 2012
First submitted
30 Aug 2005
Last updated
14 Jun 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Apaziquone in people with Bladder Neoplasms, run by Spectrum Pharmaceuticals, Inc at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to progression / Duration of remission following transurethral resection of superficial bladder cancer (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00141531.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2012.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in