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


Phase 2
18 Years
N/A
Not Enrolling
Both
Bladder Neoplasms

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Trial Information

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


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


Inclusion Criteria:



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.

Exclusion Criteria:

1. Patients having muscle-invasive disease (T2 or greater)

2. Prior intravesical treatment (chemotherapy or immunotherapy) within the last 3 months

3. Patients with existing urinary tract infection or recurrent severe bacterial cystitis

4. 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

5. 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

6. 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

7. 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)

8. 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

18 months

Safety Issue:

Yes

Principal Investigator

Alfred Witjes, MD, Prof.

Investigator Role:

Study Chair

Investigator Affiliation:

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

Authority:

Netherlands: Medicines Evaluation Board (MEB)

Study ID:

SPI 05-003

NCT ID:

NCT00141531

Start Date:

July 2005

Completion Date:

December 2009

Related Keywords:

  • Bladder Neoplasms
  • Bladder cancer
  • Superficial
  • Carcinoma in situ
  • Intravesical instillation
  • Chemotherapy
  • Adjuvant
  • Urinary Bladder Neoplasms
  • Neoplasms

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