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Phase II Study of 6 Weeks Intravesical Gemcitabine Instillation Followed By Transurethral Resection in Patients Affected By Superficial Bladder Cancer at Low Risk


Phase 2
18 Years
80 Years
Not Enrolling
Both
Superficial Bladder Cancer

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Trial Information

Phase II Study of 6 Weeks Intravesical Gemcitabine Instillation Followed By Transurethral Resection in Patients Affected By Superficial Bladder Cancer at Low Risk


Inclusion Criteria:



- Primary solitary bladder tumour not exceeding 2 cm of diameter at sonography and/or
at cystoscopy, judged by the investigator not muscle infiltrating and at low risk

- Urinary cytology negative for severe dysplasia (G3).

- ECOG performance status 0-1

- Absence of anti-coagulant therapy or acetyl-salicylic acid chronic therapy

- Absence of other present or past neoplasias except for healed skin basalioma

Exclusion Criteria:

- Tumours with infiltrative patterns at cystoscopy

- Transitional carcinoma of the upper urinary tract and prostatic urethra.

- Any previous or concomitant malignancy other than superficial bladder cancer with the
exception of cutaneous basalioma and/or cancer of the cervix, adequately treated.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate pathological complete response rate achieved by 6 week neoadjuvant intravesical administration of Gemcitabine followed by transurethral resection (TUR) or cold biopsies, in patients affected by low risk superficial bladder cancer .

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Monday-Friday 9 am-5 pm Eastern time (UTC/GMT - 5 hours, EST)

Investigator Role:

Study Chair

Investigator Affiliation:

Eli Lilly and Company

Authority:

Italy: Ministry of Health

Study ID:

8332

NCT ID:

NCT00191711

Start Date:

February 2004

Completion Date:

October 2005

Related Keywords:

  • Superficial Bladder Cancer
  • Urinary Bladder Neoplasms

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