|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ANZCTR |
|
Last refreshed on:
|
22 February 2013 |
|
Main ID: |
ACTRN12607000160437 |
|
Date of registration:
|
07/03/2007 |
|
Primary sponsor: |
|
|
Public title:
|
Intravesical Gemcitabine
|
|
Scientific title:
|
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. |
|
Date of first enrolment:
|
1/01/2005 |
|
Target sample size:
|
90 |
|
Recruitment status: |
Recruiting |
|
URL:
|
http://www.anzctr.org.au/ACTRN12607000160437.aspx |
|
Study type:
|
Interventional |
|
Study design:
|
Nonrandomised trial
Single group |
|
|
Countries of recruitment
|
|
Australia
| | | | | | | |
|
Contacts
|
|
Name:
|
Dr. Paul de Souza |
|
Address:
|
Cancer Centre
St George Hospital
Gray Street
Kogarah NSW 2217, Australia
|
|
Telephone:
|
+61 2 93503910 |
|
Email:
|
Paul.deSouza@SESIAHS.HEALTH.NSW.GOV.AU |
|
Affiliation:
|
|
|
|
Name:
|
Linda O'Malley |
|
Address:
|
Clinical Trials Unit
Cancer Centre
St George Hospital
Gray Street
Kogarah NSW 2217, Australia
|
|
Telephone:
|
+61 2 93501920 |
|
Email:
|
Linda.O'Malley@sesiahs.health.nsw.gov.au |
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
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
Age minimum:
18 Years
Age maximum:
0 Not stated
Gender:
Both males and females
|
|
Health Condition(s) or Problem(s) studied
|
|
Superficial Bladder Cancer
|
|
Intervention(s)
|
|
Intravesical gemcitabine 2g weekly for 6 weeks
|
|
Primary Outcome(s)
|
|
To determine the response rate of intravesical gemcitabine in patients with transitional cell carcinoma of the bladder (Rate of recurrence following treatment)
|
|
Secondary Outcome(s)
|
|
Pharmacokinetic blood samples
|
|
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.
|
|
To determine the toxicity and safety of weekly intravesical gemcitabine gemcitabine.
|
|
Toxicity and safety
|
|
Vital signs
|
|
Source(s) of Monetary Support
|
|
Eli Lilly Australia
|
|