Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00346099
Status:
WITHDRAWN
Last Update Posted:
2008-01-07
First Post:
2006-06-27
Brief Title:
Study of Panitumumab Given First With Capecitabine and Oxaliplatin CAPOX and Then With Capecitabine and Radiation of the Pelvis for Treatment of Patients With Rectal Cancers That May or May Not Have Spread Beyond the Rectum
Sponsor:
NSABP Foundation Inc
Organization:
NSABP Foundation Inc
Study Overview
Official Title:
A Phase II Study to Determine the Efficacy and Safety of Panitumumab in Combination With Chemoradiotherapy for Unresectable or Locally Recurrent Adenocarcinoma of the Rectum With or Without Metastatic Disease
Status:
WITHDRAWN
Status Verified Date:
2007-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Protocol closed based on new and as yet unpublished information from a phase II clinical trial
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Panitumumab is a monoclonal antibody It works by attaching to a protein called epidermal growth factor receptor found on normal and cancer cells When panitumumab attaches it blocks another protein called epidermal growth factor EGF from attaching to the cell This is important because when EGF is blocked a cells growth slows down or stops Panitumumab may also help radiation therapy work Also because panitumumab is a fully-human antibody it may be less toxic than other monoclonal antibodies made to block the EGF receptor Chemotherapy such as capecitabine and oxaliplatin works to kill cancer cells directly Capecitabine given during radiation helps radiation therapy work better This study is being done to learn how rectal cancer tumors that are not removed surgically respond to treatment with panitumumab and chemotherapy given before radiation therapy begins followed by treatment with panitumumab and capecitabine given with radiation therapy
Detailed Description:
Colorectal cancers express EGF andor EGFR mRNA in 66 of primary tumors 44 of adjacent mucosa and up to 62 of positive lymph nodes Patients enrolled in NSABP FR-1 will begin therapy with the anti-EGFR antibody panitumumab--which has shown single-agent activity in colorectal cancer patients--in combination with CAPOX an effective treatment for patients with advanced colorectal cancer with the convenience of using an oral fluoropyrimidine capecitabine The intent with this first phase is to expose distant metastases to the agents early and to shrink the tumor before giving radiation therapy After chemotherapy radiotherapy with capecitabine and panitumumab will be given to destroy the primary tumor Panitumumab is added to the radiochemotherapy regimen because data showed positive results when another anti-EGFR antibody was added to radiotherapy in patients with head and neck cancer This approach aims to improve neoadjuvant combined modality therapy for rectal cancer it should provide effective therapy for eligible patients and valuable information about clinical tumor response rates and treatment tolerability which if favorable may be used to develop future Phase III trials
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