Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003133
Status:
COMPLETED
Last Update Posted:
2013-06-28
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy Following Surgery in Treating Patients With Advanced Bladder Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Sequential Gemcitabine Doxorubicin Then Paclitaxel Plus Cisplatin Adjuvant Chemotherapy After Complete Resection of Locally Advanced Transitional Cell Carcinoma of the Urothelium
Status:
COMPLETED
Status Verified Date:
2013-06
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 Combining more than one drug may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy following surgery in treating patients with advanced bladder cancer
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy following surgery in treating patients with advanced bladder cancer
Detailed Description:
OBJECTIVES I Determine the safety and toxicity of sequential dose intensive adjuvant systemic therapy consisting of gemcitabine then doxorubin followed by paclitaxel and cisplatin with filgrastim granulocyte colony stimulating factor G-CSF for patients with completely resected locally advanced transitional cell carcinoma of the urothelium II Assess the disease free and overall survival of these patients
OUTLINE Patients receive gemcitabine IV on weeks 1 2 3 5 6 and 7 for a total of 6 doses A 1 week rest period occurs after the third dose of gemcitabine At least 14 days after the last dose of gemcitabine during the ninth week patients receive doxorubicin at 2 week intervals weeks 9 11 13 and 15 for a total of 4 doses Filgrastim granulocyte colony stimulating factor G-CSF is administered subcutaneously on days 3-10 of each cycle of doxorubicin At least 14 days after the last dose of doxorubicin during week 17 patients receive the combination of paclitaxel IV 3 hour infusion and cisplatin at 2 week intervals weeks 17 19 21 and 23 for a total of 4 doses G-CSF is again administered on days 3-10 of each of these cycles Patients are followed every 3 months for the first 2 years every 6 months for the next 3 years then annually until death
PROJECTED ACCRUAL This study will accrue 25-30 patients in 15-2 years
OUTLINE Patients receive gemcitabine IV on weeks 1 2 3 5 6 and 7 for a total of 6 doses A 1 week rest period occurs after the third dose of gemcitabine At least 14 days after the last dose of gemcitabine during the ninth week patients receive doxorubicin at 2 week intervals weeks 9 11 13 and 15 for a total of 4 doses Filgrastim granulocyte colony stimulating factor G-CSF is administered subcutaneously on days 3-10 of each cycle of doxorubicin At least 14 days after the last dose of doxorubicin during week 17 patients receive the combination of paclitaxel IV 3 hour infusion and cisplatin at 2 week intervals weeks 17 19 21 and 23 for a total of 4 doses G-CSF is again administered on days 3-10 of each of these cycles Patients are followed every 3 months for the first 2 years every 6 months for the next 3 years then annually until death
PROJECTED ACCRUAL This study will accrue 25-30 patients in 15-2 years
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-G97-1358 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000065899 | REGISTRY | None | None |