Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00085384
Status:
TERMINATED
Last Update Posted:
2012-08-02
First Post:
2004-06-10
Brief Title:
PEG-Interferon Alfa-2b in Treating Patients With Platinum-Resistant Ovarian Epithelial Peritoneal or Fallopian Tube Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase III Study to Evaluate the Optimum Dose of Pegylated-Interferon PEG INTRON in Patients With Platinum Resistant Ovarian Peritoneal or Fallopian Tube Cancer
Status:
TERMINATED
Status Verified Date:
2012-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated due to slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE PEG-interferon alfa-2b may interfere with the growth of cancer cells
PURPOSE This randomized phase III trial is studying the side effects and best dose of PEG-interferon alfa-2b and to see how well it works in treating patients with ovarian epithelial peritoneal or fallopian tube cancer that is resistant to platinum-based chemotherapy
PURPOSE This randomized phase III trial is studying the side effects and best dose of PEG-interferon alfa-2b and to see how well it works in treating patients with ovarian epithelial peritoneal or fallopian tube cancer that is resistant to platinum-based chemotherapy
Detailed Description:
OBJECTIVES
Determine the optimum biologic dose of PEG-interferon alfa-2b in patients with platinum-resistant ovarian epithelial peritoneal or fallopian tube cancer
Determine the safety and tolerability of this drug in these patients
OUTLINE This is a randomized study Patients are randomized to 1 of 3 different treatment arms
Arm I Patients receive PEG-interferon alfa-2b PEG IFN-α subcutaneously SC on days 1 8 15 and 22
Arm II Patients receive PEG IFN-α SC at a higher dose than in arm I on days 1 8 15 and 22
Arm III Patients receive PEG IFN-α SC at a higher dose than in arm II on days 1 8 15 and 22
In all arms treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity
Patients are followed for at least 28 days after study treatment
PROJECTED ACCRUAL A maximum of 75 patients will be accrued for this study within 19 months
Determine the optimum biologic dose of PEG-interferon alfa-2b in patients with platinum-resistant ovarian epithelial peritoneal or fallopian tube cancer
Determine the safety and tolerability of this drug in these patients
OUTLINE This is a randomized study Patients are randomized to 1 of 3 different treatment arms
Arm I Patients receive PEG-interferon alfa-2b PEG IFN-α subcutaneously SC on days 1 8 15 and 22
Arm II Patients receive PEG IFN-α SC at a higher dose than in arm I on days 1 8 15 and 22
Arm III Patients receive PEG IFN-α SC at a higher dose than in arm II on days 1 8 15 and 22
In all arms treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity
Patients are followed for at least 28 days after study treatment
PROJECTED ACCRUAL A maximum of 75 patients will be accrued for this study within 19 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 |
|---|---|---|---|
| P50CA083639 | NIH | None | None |
| P30CA016672 | NIH | None | None |
| MDA-ID-02115 | OTHER | None | None |
| CDR0000368964 | REGISTRY | NCI PDQ | httpsreporternihgovquickSearchP30CA016672 |