Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002917
Status:
COMPLETED
Last Update Posted:
2013-05-15
First Post:
1999-11-01
Brief Title:
Paclitaxel in Treating Patients With Early-Stage Bladder Cancer
Sponsor:
Mary Babb Randolph Cancer Center at West Virginia University Hospitals
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A PHASE III INSTITUTIONAL STUDY OF INTRAVESICAL TAXOL PACLITAXEL INSTILLATION FOR THE TREATMENT OF SUPERFICIAL BLADDER CANCER
Status:
COMPLETED
Status Verified Date:
2001-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase III trial to study the effectiveness of paclitaxel in treating patients with early-stage bladder cancer
PURPOSE Phase III trial to study the effectiveness of paclitaxel in treating patients with early-stage bladder cancer
Detailed Description:
OBJECTIVES I Evaluate toxicity and safety of intravesical paclitaxel in patients with superficial bladder cancer II Evaluate the efficacy of paclitaxel against transitional cell carcinoma in situ CIS andor unresectable papillary superficial bladder cancer III Evaluate a dose-response effect and choose an appropriate dose for further clinical study
OUTLINE Cohorts of patients receive intravesical paclitaxel in escalating doses administered twice weekly for 6 weeks then once every 2 weeks for another 6 weeks for a maximum of 2 courses at a dose level Patients must complete 8 of the first 15 instillations and a 3 month cystoscopic exam with biopsy and cytology to be deemed evaluable Participants are followed by quarterly cytoscopy and cytology for an additional 21 month period Biopsies are performed at 3 andor 6 months and thereafter if clinically applicable
PROJECTED ACCRUAL 19 evaluable patients will be enrolled
OUTLINE Cohorts of patients receive intravesical paclitaxel in escalating doses administered twice weekly for 6 weeks then once every 2 weeks for another 6 weeks for a maximum of 2 courses at a dose level Patients must complete 8 of the first 15 instillations and a 3 month cystoscopic exam with biopsy and cytology to be deemed evaluable Participants are followed by quarterly cytoscopy and cytology for an additional 21 month period Biopsies are performed at 3 andor 6 months and thereafter if clinically applicable
PROJECTED ACCRUAL 19 evaluable patients will be enrolled
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-V97-1114 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000065299 | REGISTRY | None | None |