NCT00191711CompletedPhase 2
Phase II Study of 6 Weeks Intravesical Gemcitabine Instillation Followed By Transurethral Resection in Patients Affected By Superficial Bladder Cancer at Low Risk
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Eli Lilly and Company
- Enrollment
- 43
- Locations
- 1
- Primary Endpoint
- 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 .
Study Overview
Brief Summary
The purpose of this study is to determine whether neoadjuvant intravesical Gemcitabine is enough active in patients with a solitary, low risk superficial bladder cancer.After diagnostic urethrocystoscopy or bladder sonography, all patients will receive intravesical gemcitabine once a week during 6 weeks. Two weeks after finishing antiblastic therapy, all patients will be submitted to a new cystoscopy, with TUR or cold biopsies of the site of the initial lesion.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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 .
Secondary Outcomes
- To assess toxicity profile in the same group of patients.
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 2
A Randomized Study Evaluating the Feasibility and Activity of Three Different Combination With Gemcitabine as First Line Therapy for Non Small Cell Lung CancerCarcinoma, Non-Small-Cell LungNCT00191490Eli Lilly and Company162
Terminated
Phase 2
Adjuvant Intraperitoneal Gemcitabine for Resectable Pancreatic AdenocarcinomaPancreatic AdenocarcinomaNCT01206296Medstar Health Research Institute9
Completed
Phase 2
Intravesical Chemotherapy Treatment of Superficial Bladder CancerBladder NeoplasmsNCT00491114Eli Lilly and Company8
Unknown
Phase 2
The Effectiveness and Safety of Intravesical Gemcitabine Instillation to Prevent Intravesical RecurrenceUrothelial CarcinomaNCT03062059National Cancer Center, Korea134
Active, not recruiting
Phase 2
Intravesical Gemcitabine and Docetaxel for BCG naïve Non-muscle Invasive Bladder CancerUrothelial Carcinoma BladderBladder CancerNCT04386746Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins27