Intravesical Gemcitabine

A Phase ll trial to measure the response rate (Rate of recurrence following treatment) ,toxicity and safety of weekly intravesical gemcitabine in patients with transitional cell carcinoma of the bladder.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000160437

Enrollment

Registered

2007-03-07

Start date

2005-01-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The treatment for recurrent bladder tumour following trans-urethral resection (TUR) continues to be problematic. This protocol is a phase ll trial of gemcitabine directly instilled into the bladder of patients with transitional cell carcinoma who have undergone a standard TUR. The objectives of the study are to determine if intravesical gemcitabine is capable of reducing the rate of tumour recurrence in the bladder. Patients with transitional cell carcinoma who are at risk of recurrence following TUR, or who have failed previous standard treatment with intravesical BCG are eligible for the study. Patients will receive weekly bladder instillation of 2000mg of gemcitabine via a catheter, followed by re-evaluation of disease at 3 months by the urologist. Toxicity is expected to be minimal. The results of this trial will allow a phase lll trial comparing intravesical gemcitabine with BCG or mitomycin C to be undertaken.

Interventions

Intravesical gemcitabine 2g weekly for 6 weeks

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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

Outcome results