WARNING: DERMATOLOGIC TOXICITY
Dermatologic Toxicity: Dermatologic toxicities occurred in 90% of patients and were severe (NCI-CTC grade 3 and higher) in 15% of patients receiving
[see Dosage and Administration (
Warnings and Precautions (
), and Adverse Reactions (
Vectibix (panitumumab) is a recombinant, human IgG2 kappa monoclonal antibody that binds specifically to the human epidermal growth factor receptor (EGFR).
Vectibix is indicated as a single agent for the treatment of EGFR-expressing, metastatic colorectal carcinoma (mCRC) with disease progression on or following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.
The effectiveness of Vectibix as a single agent for the treatment of EGFR-expressing, metastatic colorectal carcinoma is based on progression-free survival [see Clinical Studies]. Currently, no data demonstrate an improvement in disease-related symptoms or increased survival with Vectibix.
Media Articles Related to Vectibix (Panitumumab)
Genetic cause of 15 percent of colorectal cancer diagnoses identified
Source: Colorectal Cancer News From Medical News Today [2016.07.20]
Findings open up 'precision medicine' approach to prevention, diagnosis and treatment.
Internal radiation therapy: Better response in metastatic colorectal cancer patients
Source: Colorectal Cancer News From Medical News Today [2016.07.10]
New analysis shows patients with metastatic colorectal cancer treated with radiation therapy show better response than those receiving chemotherapy alone.
Colorectal cancer: Pivotal Phase III data for Xilonix presented
Source: Clinical Trials / Drug Trials News From Medical News Today [2016.07.05]
XBiotech Inc., developer of next-generation True Human™ antibody therapies, has presented positive results from a pivotal Phase III trial of Xilonix™, the company's lead monoclonal...
Anti-PD-L1 immunotherapy shows response in microsatellite-stable metastatic colorectal cancer in combination with MEK inhibition
Source: Colorectal Cancer News From Medical News Today [2016.07.04]
Anti-PD-L1 immunotherapy may achieve a response in patients with microsatellite-stable metastatic colorectal cancer if combined with a MEK inhibitor, according to phase I data presented at the ESMO...
Are older adults being appropriately screened for colorectal cancer?
Source: Colorectal Cancer News From Medical News Today [2016.06.23]
Who should consider colorectal cancer (CRC) screening and why? CRC is a common and costly disease, largely of the elderly, with nearly 25% of cases diagnosed among patients aged 75-84 years, but...
Published Studies Related to Vectibix (Panitumumab)
Health-related quality of life and colorectal cancer-specific symptoms in patients with chemotherapy-refractory metastatic disease treated with panitumumab. [2011.02]
PURPOSE: Panitumumab monotherapy is approved for chemotherapy-refractory wild-type KRAS metastatic colorectal cancer (mCRC). Patient-reported outcomes-although important in the palliative setting-have not been reported in this patient population... CONCLUSIONS: Panitumumab-treated patients with wild-type KRAS mCRC maintained better control of CRC symptoms and quality of life compared with BSC alone, extending our understanding of the benefits of panitumumab treatment beyond improvements in progression-free survival.
Randomized, phase III trial of panitumumab with infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX4) versus FOLFOX4 alone as first-line treatment in patients with previously untreated metastatic colorectal cancer: the PRIME study. [2010.11.01]
PURPOSE: Panitumumab, a fully human anti-epidermal growth factor receptor (EGFR) monoclonal antibody that improves progression-free survival (PFS), is approved as monotherapy for patients with chemotherapy-refractory metastatic colorectal cancer (mCRC). The Panitumumab Randomized Trial in Combination With Chemotherapy for Metastatic Colorectal Cancer to Determine Efficacy (PRIME) was designed to evaluate the efficacy and safety of panitumumab plus infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX4) versus FOLFOX4 alone as initial treatment for mCRC... CONCLUSION: This study demonstrated that panitumumab-FOLFOX4 was well tolerated and significantly improved PFS in patients with WT KRAS tumors and underscores the importance of KRAS testing for patients with mCRC.
Randomized phase III study of panitumumab with fluorouracil, leucovorin, and irinotecan (FOLFIRI) compared with FOLFIRI alone as second-line treatment in patients with metastatic colorectal cancer. [2010.11.01]
PURPOSE: Panitumumab is a fully human anti-epidermal growth factor receptor (EGFR) monoclonal antibody that improves progression-free survival (PFS) in chemotherapy-refractory metastatic colorectal cancer (mCRC). This trial evaluated the efficacy and safety of panitumumab plus fluorouracil, leucovorin, and irinotecan (FOLFIRI) compared with FOLFIRI alone after failure of initial treatment for mCRC by tumor KRAS status... CONCLUSION: Panitumumab plus FOLFIRI significantly improved PFS and is well-tolerated as second-line treatment in patients with WT KRAS mCRC.
Skin toxicity evaluation protocol with panitumumab (STEPP), a phase II, open-label, randomized trial evaluating the impact of a pre-Emptive Skin treatment regimen on skin toxicities and quality of life in patients with metastatic colorectal cancer. [2010.03.10]
PURPOSE: Panitumumab, a fully human monoclonal antibody targeting the epidermal growth factor receptor (EGFR), is approved in the United States and Europe for the treatment of refractory metastatic colorectal cancer (mCRC). Skin toxicities are the most common adverse events with EGFR inhibitors. This is the first study designed to examine differences between pre-emptive and reactive skin treatment for specific skin toxicities in patients with mCRC for any EGFR inhibitor... CONCLUSION: The pre-emptive skin treatment regimen was well tolerated. The incidence of specific >or= grade 2 skin toxicities during the 6-week skin treatment period was reduced by more than 50% in the pre-emptive group compared with the reactive group. Patients in the pre-emptive group reported less QOL impairment than patients in the reactive group.
Association of progression-free survival, overall survival, and patient-reported outcomes by skin toxicity and KRAS status in patients receiving panitumumab monotherapy. [2009.04.01]
BACKGROUND: The authors explored the association of skin toxicity (ST) severity as measured by patient-reported ST and Common Terminology Criteria for Adverse Events (CTCAE) grading with efficacy of panitumumab, a fully human antiepidermal growth factor receptor antibody, from a phase 3 metastatic colorectal cancer (CRC) trial... CONCLUSIONS: More severe ST, by both clinical grading and PRO, is associated with better CRC symptoms and HRQOL and with longer OS and PFS among panitumumab-treated patients. The associations for PFS were more pronounced in patients with WT KRAS tumors. (c) 2009 American Cancer Society
Clinical Trials Related to Vectibix (Panitumumab)
Panitumumab Combination Study With Rilotumumab or Ganitumab in Wild-type Kirsten Rat Sarcoma Virus Oncogene Homolog (KRAS) Metastatic Colorectal Cancer (mCRC) [Completed]
This study is a global, multicenter, open-label phase 1b and randomized, double-blinded, 2
part, phase 2 study designed to evaluate the safety and efficacy of rilotumumab or ganitumab
in combination with panitumumab versus panitumumab alone in patients with metastatic
colorectal cancer whose tumors are wild-type KRAS status.
Cabozantinib and Panitumumab to Treat KRAS Wild-Type Metastatic Colorectal Cancer [Recruiting]
There will be three parts to this phase I study: 1) the Combination Dose Finding cohort; 2)
the Combination Expansion cohort; and 3) the Monotherapy MET Amplified cohort. In the
Combination Dose Finding cohort and the Combination Expansion cohort, we will combine
cabozantinib and panitumumab in patients with KRAS wild-type metastatic colorectal cancer
(CRC). In the Monotherapy MET Amplified cohort, we will screen at least 50 patients for MET
gene amplification ("MET amplification"). Patients with MET amplification will receive
cabozantinib only (monotherapy).
The primary objective of this open-label phase Ib trial are:
1. To determine the maximum tolerated dose and the recommended phase II dose for the
combination of cabozantinib and panitumumab in patients with KRAS wild-type metastatic
colorectal cancer and
2. To identify the objective response rate (ORR) of cabozantinib monotherapy in patients
with prospectively identified MET amplified metastatic colorectal cancer.
The secondary objectives are:
1. To describe the non-dose limiting toxicities of cabozantinib and panitumumab.
2. To describe the clinical activity (ORR, PFS, OS) of cabozantinib and panitumumab.
3. To describe the safety and tolerability of cabozantinib monotherapy in patients with
MET amplified colorectal cancer.
4. To describe the clinical activity (PFS, OS) of cabozantinib monotherapy in patients
with MET amplified colorectal cancer.
Panitumumab and Irinotecan for Malignant Gliomas [Terminated]
This is a phase II study of the combination of panitumumab with irinotecan in malignant
glioma patients. The primary objective of the study is to determine the activity of the
combination of panitumumab with irinotecan as measured by 6-month progression-free survival.
Secondary objectives include the following- to determine the safety of panitumumab in
combination with irinotecan in patients with malignant glioma; to determine the effect of
panitumumab in combination with irinotecan on corticosteroid dose for each patient; to
explore any relationship between epidermal growth factor receptor (EGF-R) mutational
analysis and efficacy or toxicity; and, to determine the response rate and overall survival
of recurrent glioblastoma (GBM) patients treated with panitumumab in combination with
The patients will have histologically documented grade 4 malignant gliomas (glioblastoma
multiforme or gliosarcoma) that have failed at least one prior chemotherapy regimen and all
patients will have received radiation therapy. This study will investigate second or greater
line of therapy for recurrent grade 4 malignant glioma. The patient population will include
The patients will undergo a baseline magnetic resonance imaging (MRI) as well as a MRI after
every six-week cycle to determine response and progression. After 16 patients with recurrent
GBM are treated, an interim analysis will be conducted. The most common side effects
associated with panitumumab have been dermatological (skin) problems such as erythema
(redness of the skin), acneiform rash (skin eruptions of the face), skin exfoliation,
pruritus (itching), skin fissures (skin tears), xerosis (dryness of the eye, skin, or
mouth), and rash. The most common side effects associated with irinotecan have been
decreased blood counts of platelets (increased risk of bleeding), white blood cells
(increased risk of infection), red blood cells (anemia); diarrhea, constipation, nausea,
vomiting, tiredness, fever, mouth sores, dehydration (excessive loss of body fluids), rash,
itching, changes in skin color, swelling, numbness, tingling, dizziness, confusion, low
blood pressure, sweating, hot flashes, hair loss, inflammation of the liver, flu-like
symptoms, decreased urine output, shortness of breath, and pneumonia (inflammatory disease
of the lungs).
Chemoradiation With Gemcitabine in Combination With Panitumumab for Patients With Locally Advanced Pancreatic Cancer [Active, not recruiting]
The purpose of this study is to investigate whether the addition of panitumumab to
radiotherapy plus gemcitabine will increase the number of patients who are alive and
progression free at 7 months.
Maintenance Therapy With 5-FU/FA Plus Panitumumab vs. 5-FU/FA Alone After Prior Induction and Re-induction After Progress for 1st-line Treatment of Metastatic Colorectal Cancer [Recruiting]
This is a phase II, randomized, multi-center, open-label, parallel-group study to evaluate
the progression-free survival during maintenance therapy.
Eligible patients will be treated within a 12-week induction therapy. Those patients
achieving CR/PR or SD at 12 weeks and qualifying for maintenance treatment and re-induction
treatment with all potential drug components, will be randomized in a ratio of 1: 1 to
receive chemotherapy plus panitumumab or chemotherapy alone during maintenance. In case of
progression, re-induction treatment will be started.
Reports of Suspected Vectibix (Panitumumab) Side Effects
Disease Progression (12),
Skin Toxicity (10),
Skin Reaction (8),
DRY Skin (8),
Pulmonary Embolism (7),
Eczema (7), more >>
Page last updated: 2016-07-20