Instillation of Gemcitabine in Patients With Superficial Bladder Cancer
This study has been terminated.
(The study was stopped early for futility reasons.)
Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00191477
First received: September 12, 2005
Last updated: September 24, 2009
Last verified: September 2009
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Purpose
A randomized, double-blind, placebo-controlled Phase 3 multicenter study to assess the efficacy and safety of intravesical instillation of gemcitabine versus placebo immediately after transurethral resection of the bladder tumor.
| Condition | Intervention | Phase |
|---|---|---|
|
Bladder Neoplasms |
Drug: Gemcitabine Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled Phase 3 Multicenter Study of Immediate Postoperative Instillation of Gemcitabine in Patients With Superficial Transitional Cell Carcinoma of the Bladder |
Resource links provided by NLM:
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- Recurrence-Free Survival (RFS) [ Time Frame: Surgery to recurrence or death (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Time to Recurrence [ Time Frame: Surgery to recurrence (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months) ] [ Designated as safety issue: No ]
- Recurrence-Free Survival (RFS) in Subgroups [ Time Frame: Surgery to recurrence or death (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months) ] [ Designated as safety issue: No ]
- Tumor Recurrence Type [ Time Frame: Surgery to recurrence (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months) ] [ Designated as safety issue: No ]
| Enrollment: | 355 |
| Study Start Date: | January 2004 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: Gemcitabine
2000 mg, intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
Other Names:
|
| Placebo Comparator: B |
Drug: Placebo
intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Clinical evidence of superficial transitional cell carcinoma of the bladder
- Males or females at least 18 years of age
- Karnofsky Performance Status greater than or equal to 70%
- Patient compliance and geographic proximity that allow adequate follow-up
- Female patients with reproductive potential must use a reliable contraceptive method if appropriate (for example, intrauterine device [IUD], birth control pills, or barrier device) during the study. Female patients with reproductive potential must have a negative serum pregnancy test within 7 days of study enrollment.
- Signed informed consent.
Exclusion Criteria:
- Clinical evidence of muscle-invasive or locally advanced bladder cancer
- Clinical evidence of upper urinary tract tumor
- Distant metastases
- Other malignancies within the last 2 years, except non-melanotic skin tumors, carcinoma in situ of the cervix or organ-confined prostate cancer after curative therapy
- Severe concomitant psychiatric disease
- Febrile, active infection
- Other serious concomitant disorders that would compromise the safety of the patient or his/her ability to complete the study according to the protocol, at the discretion of the investigator (for example, unstable angina pectoris, uncontrolled diabetes mellitus)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00191477
Locations
| Germany | |
| For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559,1-317-615-4559) Mon-Fri from 9AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physici | |
| Reinfeld, Germany, 23858 | |
Sponsors and Collaborators
Eli Lilly and Company
Investigators
| Study Chair: | Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
More Information
Additional Information:
No publications provided by Eli Lilly and Company
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Chief Medical Officer, Eli Lilly |
| ClinicalTrials.gov Identifier: | NCT00191477 History of Changes |
| Other Study ID Numbers: | 6138, B9E-MC-S274 |
| Study First Received: | September 12, 2005 |
| Results First Received: | March 17, 2009 |
| Last Updated: | September 24, 2009 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Additional relevant MeSH terms:
|
Urinary Bladder Neoplasms Neoplasms Carcinoma, Transitional Cell Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Urinary Bladder Diseases Urologic Diseases Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Gemcitabine Antimetabolites, Antineoplastic |
Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents |
ClinicalTrials.gov processed this record on May 19, 2013