Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00014690
Status:
COMPLETED
Last Update Posted:
2013-08-02
First Post:
2001-04-10
Brief Title:
ZD9331 With or Without Topotecan in Treating Patients With Refractory or Recurrent Epithelial Ovarian Cancer Fallopian Tube Cancer or Primary Peritoneal Cancer
Sponsor:
AstraZeneca
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Open Randomized Multicenter Trial to Assess the Efficacy and Tolerability of Intravenous ZD9331 Given as Monotherapy at Two Doses or in Combination With Topotecan in Patients With Ovarian Cancer Refractory or Recurrent After Failing Platinum and Paclitaxel in Combination
Status:
COMPLETED
Status Verified Date:
2004-12
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 two or more drugs may kill more tumor cells
PURPOSE Randomized phase II trial to study the effectiveness of different regimens of ZD9331 with or without topotecan in treating patients who have refractory or recurrent epithelial ovarian cancer fallopian tube cancer or primary peritoneal cancer
PURPOSE Randomized phase II trial to study the effectiveness of different regimens of ZD9331 with or without topotecan in treating patients who have refractory or recurrent epithelial ovarian cancer fallopian tube cancer or primary peritoneal cancer
Detailed Description:
OBJECTIVES I Compare the efficacy of ZD9331 with or without topotecan in patients with refractory or recurrent ovarian epithelial primary peritoneal or fallopian tube cancer II Compare the tolerability of these regimens in these patients III Compare the objective tumor response rate progression-free survival and disease control in patients treated with these regimens IV Compare the quality of life of patients treated with these regimens
OUTLINE This is a randomized open-label multicenter study Patients are randomized to 1 of 3 treatment arms Arm I Patients receive ZD9331 IV over 30 minutes on days 1 and 8 Arm II Patients receive a higher dose of ZD9331 IV over 30 minutes on days 1 and 8 Arm III Patients receive ZD9331 as in arm I and topotecan IV over 30 minutes on days 1-5 All arms Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity Quality of life is assessed at baseline on the first day of each course and then at study withdrawal Patients are followed at day 30 every 9 weeks until disease progression and then every 6 months thereafter
PROJECTED ACCRUAL Approximately 130 patients will be accrued for this study within 5 months
OUTLINE This is a randomized open-label multicenter study Patients are randomized to 1 of 3 treatment arms Arm I Patients receive ZD9331 IV over 30 minutes on days 1 and 8 Arm II Patients receive a higher dose of ZD9331 IV over 30 minutes on days 1 and 8 Arm III Patients receive ZD9331 as in arm I and topotecan IV over 30 minutes on days 1-5 All arms Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity Quality of life is assessed at baseline on the first day of each course and then at study withdrawal Patients are followed at day 30 every 9 weeks until disease progression and then every 6 months thereafter
PROJECTED ACCRUAL Approximately 130 patients will be accrued for this study within 5 months
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 |
|---|---|---|---|
| CDR0000068604 | REGISTRY | PDQ Physician Data Query | None |