PACCE: Panitumumab Advanced Colorectal Cancer Evaluation Study
Summary
The purpose of this study is to assess whether treatment with the study drug, panitumumab given concomitantly with every 2 (Q2) week oxaliplatin-based chemotherapy and bevacizumab improves progression-free survival (PFS) compared to treatment with Q2-week oxaliplatin-based chemotherapy and bevacizumab alone. All subjects will receive Q2-week oxaliplatin- or irinotecan-based chemotherapy and bevacizumab. Control arm subjects will not receive concomitant panitumumab therapy.
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Colorectal Cancer
Intervention
Bevacizumab, Panitumumab
Location
Research Site
Birmingham
Alabama
United States
Status
Completed
Source
Amgen
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00115765
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Colorectal Neoplasms
Tumors or cancer of the COLON or the RECTUM or both. Risk factors for colorectal cancer include chronic ULCERATIVE COLITIS; FAMILIAL POLYPOSIS COLI; exposure to ASBESTOS; and irradiation of the CERVIX UTERI.
Genes, Mcc
Tumor suppressor genes located in the 5q21 region on the long arm of human chromosome 5. The mutation of these genes is associated with the formation of colorectal cancer (MCC stands for mutated in colorectal cancer).
Genes, Dcc
Tumor suppressor genes located in the 18q21-qter region of human chromosome 18. The absence of these genes is associated with the formation of colorectal cancer (DCC stands for deleted in colorectal cancer). The products of these genes show significant homology to neural cell adhesion molecules and other related cell surface glycoproteins.
Colorectal Neoplasms, Hereditary Nonpolyposis
A group of autosomal-dominant inherited diseases in which COLON CANCER arises in discrete adenomas. Unlike FAMILIAL POLYPOSIS COLI with hundreds of polyps, hereditary nonpolyposis colorectal neoplasms occur much later, in the fourth and fifth decades. HNPCC has been associated with germline mutations in mismatch repair (MMR) genes. It has been subdivided into Lynch syndrome I or site-specific colonic cancer, and LYNCH SYNDROME II which includes extracolonic cancer.
Tumor Suppressor Protein P53
Nuclear phosphoprotein encoded by the p53 gene (GENES, P53) whose normal function is to control CELL PROLIFERATION and APOPTOSIS. A mutant or absent p53 protein has been found in LEUKEMIA; OSTEOSARCOMA; LUNG CANCER; and COLORECTAL CANCER.
Clinical Trials
Bevacizumab given at 7.5mg/kg. IV over 10-90 minutes every 3 weeks until disease progression.Panitumumab given at 9mg/kg. IV over 30-90 minutes every 3 weeks until disease progression.Prim...
Panitumumab Regimen Evaluation in Colorectal Cancer to Estimate Primary Response to Treatment
This is a phase 2, multi center, open label, single arm, clinical trial to be conducted in the United States. Subjects with metastatic colorectal cancer who failed (due to disease progres...
Panitumumab in Cetuximab Refractory KRAS Wild-Type Colorectal Cancer
The purpose of this research study is to learn whether panitumumab helps treat colorectal cancer in participants who have not responded to treatment with cetuximab. Panitumumab is a human...
BEP Study Phase I (Bevacizumab, Everolimus, Panitumumab)
Targeting molecular pathways of tumor growth has become a major focus of anti-cancer treatments. This study aims to investigate the toxicity, pharmacokinetics, and preliminary efficacy of...
SPIRITT - Second-Line Panitumumab Irinotecan Treatment Trial
This is a multi-center, open-label, randomized, phase 2, two-arm clinical trial to be conducted in the United States. Approximately 210 eligible KRAS wild-type expressing metastatic color...
PubMed Articles
Bevacizumab as a second- or later-line of treatment for metastatic colorectal cancer.
To determine the efficacy of bevacizumab in patients with metastatic colorectal cancer (MCRC) who have failed prior chemotherapy without bevacizumab.
Bevacizumab 5 or 7.5 mg/kg in Metastatic Colorectal Cancer Can Be Infused Safely Over 10 Minutes.
BACKGROUND: Bevacizumab is a humanized monoclonal antibody that blocks vascular endothelial factor. It demonstrated an efficacy in many cancer types. The standard recommendation of administration is t...
Bevacizumab plus Irinotecan-Based Regimens in the Treatment of Metastatic Colorectal Cancer.
Objectives: Bevacizumab is a monoclonal antibody that directly inhibits vascular endothelial growth factor, a key regulator of angiogenesis. Bevacizumab significantly improves progression-free and/or...
Bevacizumab: current updates in treatment.
PURPOSE OF REVIEW: Drugs targeting angiogenesis are rapidly being incorporated into cancer treatment regimens. Bevacizumab was the first antiangiogenesis agent to gain approval by the Food and Drug Ad...
Abstract Purpose. In breast cancer patients, Mailliez and others described that 5 of 70 patients (7%) developed a bevacizumab-induced nasal septal perforation. However, to date, no studies have report...
