Intravesical Gemcitabine

Phase 2

Recruiting

• Conditions: Superficial Bladder Cancer; Cancer - Bladder

• Registration Number: ACTRN12607000160437
• Lead Sponsor: St George Hospital, Kogarah

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-03-07
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Patients must have either i) newly diagnosed superficial transitional cell carcinoma of the bladder, up to G3cT1, previously untreated by intravesical chemotherapy (Group A), or,ii) recurrent superficial transitional cell carcinoma of the bladder after at least one previous course of intravesical Bacillus Calmette-Guerin (BCG) or Mitomycin (Group B). At least 12 weeks must have elapsed since the last BCG or Mitomycin treatment.• Pathologic or cytologic confirmation of transitional cell carcinoma. • Males or females are eligible Karnofsky Performance Status (KPS) >70% • Adequate marrow function defined as neutrophils > 1.5x109/l and platelets >100 x109/l• Adequate hepatic function defined as total bilirubin < 1.5 x normal and aspartate aminotransferase (AST), alanine aminotransferase (ALT) < 3 times normal• Informed consent.

Exclusion Criteria

• Prior radiation to the bladder. Previous radiation to other sites in the pelvis (eg. Prostate) is allowed, provided no more than 25% of the pelvis was included in the radiation (RT) field, and all side effects from RT have resolved.• Muscle invasive disease at baseline cystoscopy• Untreated urinary tract infection or abscess within the previous 7 days• Other concerns that in the opinion of the investigator, would make it difficult or unethical for a patient to undergo intravesical treatment within approximately 6 weeks of baseline cystoscopy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the response rate of intravesical gemcitabine in patients with transitional cell carcinoma of the bladder (Rate of recurrence following treatment)[Three monthly cystoscopies +/- biopsy for one year following initial treatment.]

Secondary Outcome Measures

Name	Time	Method
To determine the toxicity and safety of weekly intravesical gemcitabine gemcitabine.[For 6 weeks during the intervention.];To determine the systemic exposure of gemcitabine when given by an intravesical route with weekly haematology, erythrocyte sedimentation rate (ESR) and C reactive protein (CRP) for 8 weeks and liver function tets (LFTs) and biochemistry (UECs) fortnightly during treatment.[];Vital signs[Recorded weekly pre and post treatment. ];Toxicity and safety[Assessed at a clinic visit after the third and sixth treatment and laboratory tests (the weekly blood tests for 8 weeks).];Pharmacokinetic blood samples[Obtained prior to intravesical treatment , then at 30, 60, 90, 120 and 180 minutes after the start of the first instillation of gemcitabine only.]