Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00057928
Status:
WITHDRAWN
Last Update Posted:
2012-06-13
First Post:
2003-04-07
Brief Title:
S0227 Cisplatin With Either Paclitaxel or Gemcitabine in Recurrent Persistent or Metastatic Cervical Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
Phase III Randomized Trial of CisplatinPaclitaxel Versus CisplatinGemcitabine in Recurrent Persistent or Metastatic Carcinoma of the Cervix
Status:
WITHDRAWN
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
lack of accrual
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 It is not yet known whether cisplatin is more effective when combined with paclitaxel or gemcitabine in treating cervical cancer
PURPOSE Randomized phase III trial to compare the effectiveness of cisplatin combined with paclitaxel to that of cisplatin combined with gemcitabine in treating women who have recurrent persistent or metastatic cervical cancer
PURPOSE Randomized phase III trial to compare the effectiveness of cisplatin combined with paclitaxel to that of cisplatin combined with gemcitabine in treating women who have recurrent persistent or metastatic cervical cancer
Detailed Description:
OBJECTIVES
Compare the overall survival progression-free survival and objective response rate confirmed and unconfirmed complete and partial of patients with recurrent persistent or metastatic cervical cancer treated with cisplatin and paclitaxel vs cisplatin and gemcitabine
Compare the toxicity of these regimens in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to disease status at study entry metastatic vs recurrent vs persistent prior cisplatin as a radiosensitizer yes vs no and extent of disease confined to pelvis vs extrapelvic disease Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 2 hours on day 2
Arm IIPatients receive gemcitabine IV over 30 minutes on days 1 and 8 and cisplatin IV over 2 hours on day 1
In both arms treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years and then annually for 3 years
PROJECTED ACCRUAL A total of 500 patients 250 per treatment arm will be accrued for this study within 4 years
Compare the overall survival progression-free survival and objective response rate confirmed and unconfirmed complete and partial of patients with recurrent persistent or metastatic cervical cancer treated with cisplatin and paclitaxel vs cisplatin and gemcitabine
Compare the toxicity of these regimens in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to disease status at study entry metastatic vs recurrent vs persistent prior cisplatin as a radiosensitizer yes vs no and extent of disease confined to pelvis vs extrapelvic disease Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 2 hours on day 2
Arm IIPatients receive gemcitabine IV over 30 minutes on days 1 and 8 and cisplatin IV over 2 hours on day 1
In both arms treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years and then annually for 3 years
PROJECTED ACCRUAL A total of 500 patients 250 per treatment arm will be accrued for this study within 4 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 |
|---|---|---|---|
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |
| S0227 | OTHER | None | None |