Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-03-02 @ 10:05 PM
Study NCT ID:
NCT00861120
Status:
COMPLETED
Last Update Posted:
2012-10-26
First Post:
2009-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Panitumumab and Pegylated Liposomal Doxorubicin for Platinum-Resistant Epithelial Ovarian Cancer With KRAS Wild-type
Sponsor:
Vejle Hospital
Organization:
Study Overview
Official Title:
Panitumumab and Pegylated Liposomal Doxorubicin for Platinum-Resistant Epithelial Ovarian Cancer With Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Wild-type
Status:
COMPLETED
Status Verified Date:
2012-10
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:
PaLiDo
Brief Summary:
The purpose of this study is to investigate the response rate in platinum-resistant, KRAS wild-type, ovarian cancer patients who are treated with pegylated liposomal doxorubicin (Caelyx®) in combination with biological treatment panitumumab (Vectibix®).
Detailed Description:
Patients with platinum-resistant recurrent ovarian cancer have few therapeutic options and the response rates are only 10-20% using non-cross-resistant chemotherapeutic agents.
New biologic agents in combination with chemotherapy or other treatment modalities may result in improvement in survival.
Recent results in colorectal cancer have clearly indicated that KRAS mutant tumors do not respond to treatment with EGFR inhibitors.
Panitumumab (ABX-EGF) is the first fully human monoclonal antibody specific to the EGF receptor. To date, panitumumab has been evaluated in combination with chemotherapy in patients with CRC, NSCLC, and SCCHN.
No previous studies have evaluated the effect of panitumumab in epithelial ovarian cancer based on KRAS mutation status.
New biologic agents in combination with chemotherapy or other treatment modalities may result in improvement in survival.
Recent results in colorectal cancer have clearly indicated that KRAS mutant tumors do not respond to treatment with EGFR inhibitors.
Panitumumab (ABX-EGF) is the first fully human monoclonal antibody specific to the EGF receptor. To date, panitumumab has been evaluated in combination with chemotherapy in patients with CRC, NSCLC, and SCCHN.
No previous studies have evaluated the effect of panitumumab in epithelial ovarian cancer based on KRAS mutation status.
Study Oversight
Has Oversight DMC:
True
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?: