Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00022191
Status:
COMPLETED
Last Update Posted:
2013-06-12
First Post:
2001-08-10
Brief Title:
Cisplatin Plus Gemcitabine With or Without Paclitaxel in Treating Patients With Stage IV Urinary Tract Cancer
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Randomized Phase III Study Comparing PaclitaxelCisplatinGemcitabine and CisplatinGemcitabine in Patients With Metastatic or Locally Advanced Urothelial Cancer Without Prior Systemic Therapy
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 It is not yet known which combination chemotherapy regimen is more effective for urinary tract cancer
PURPOSE Randomized phase III trial to compare the effectiveness of cisplatin plus gemcitabine with or without paclitaxel in treating patients who have stage IV urinary tract cancer
PURPOSE Randomized phase III trial to compare the effectiveness of cisplatin plus gemcitabine with or without paclitaxel in treating patients who have stage IV urinary tract cancer
Detailed Description:
OBJECTIVES
Compare the duration of survival of patients with stage IV transitional cell carcinoma of the urothelium treated with cisplatin and gemcitabine with or without paclitaxel
Compare the duration of progression-free survival response rates and duration of response in patients treated with these regimens
Compare the toxicity of these regimens in these patients
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to participating center WHO performance status 0 vs 1 and presence of metastatic disease yes vs no Patients are randomized to one of two treatment arms
Arm I Patients receive gemcitabine IV over 30 minutes on days 1 8 and 15 and cisplatin IV over 1 hour on day 1 or 2 Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients receive paclitaxel IV over 1 hour on days 1 and 8 followed by cisplatin IV over 1 hour on day 1 and gemcitabine IV over 30 minutes on days 1 and 8 Treatment repeats every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years and then every 6 months for at least 3 years
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 610 patients 305 per treatment arm will be accrued for this study within 304 years
Compare the duration of survival of patients with stage IV transitional cell carcinoma of the urothelium treated with cisplatin and gemcitabine with or without paclitaxel
Compare the duration of progression-free survival response rates and duration of response in patients treated with these regimens
Compare the toxicity of these regimens in these patients
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to participating center WHO performance status 0 vs 1 and presence of metastatic disease yes vs no Patients are randomized to one of two treatment arms
Arm I Patients receive gemcitabine IV over 30 minutes on days 1 8 and 15 and cisplatin IV over 1 hour on day 1 or 2 Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients receive paclitaxel IV over 1 hour on days 1 and 8 followed by cisplatin IV over 1 hour on day 1 and gemcitabine IV over 30 minutes on days 1 and 8 Treatment repeats every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years and then every 6 months for at least 3 years
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 610 patients 305 per treatment arm will be accrued for this study within 304 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 |
|---|---|---|---|
| MRC-BA11 | None | None | None |
| EORTC-30987 | None | None | None |
| CAN-NCIC-BL7 | None | None | None |
| CECOG-EORTC-30987 | None | None | None |
| GAUO-EORTC-30987 | None | None | None |
| GETUG-EORTC-30987 | None | None | None |
| SOGUG-EORTC-30987 | None | None | None |
| SWOG-30987 | None | None | None |
| NCRI-CRUK-BA11 | None | None | None |