Study of First-line Single-agent Panitumumab in Frail Elderly Patients With Advanced Wild Type K-RAS Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the efficacy and safety of first-line single-agent panitumumab in frail elderly patients with advanced Wild Type K-RAS colorectal cancer

Detailed Description
-----------------
The purpose of the study is to evaluate the efficacy and safety of first-line single-agent panitumumab in frail elderly patients with advanced Wild Type K-RAS colorectal cancer

Official Title
-----------------
Phase II Study of First-line Single-agent Panitumumab in Frail Elderly Patients With Advanced Wild Type K-RAS Colorectal Cancer

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Biological: Panitumumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed Inform Consent Age > 70 years. Histologically documented metastatic colorectal cancer not candidate for surgical resection Wild type K-RAS Measurable disease by RECIST Criteria Intermediate or High-risk group according to the Köhne Prognostic Classification ECOG status < 3 Magnesium ≥ institutional lower limit of normal frail elderly patients and or not candidates for chemotherapy: Frail elderly patients: Presence of one or more of the following criteria: Dependence for one of the basic daily living activities (Katz Index) Three or more comorbid conditions according Charlson scale and dependence for one of the instrumental activities of daily living (IADL) Presence one or more of the following geriatric syndromes (age > 85 years, fecal or urinary incontinence in the absence of stress, frequent falls, spontaneous bone fractures, neglect) Presence of one or more of the following criteria that make patients not candidates for chemotherapy: neutrophils < 2000/mm3 platelets < 100.000/mm3 creatinine clearance < 30 ml/min and bilirubin levels > 1.5 x ULN creatinine clearance < 30 ml/min and AST or ALT levels > 3 x UNL (if liver metastasis > 5 x ULN) Exclusion Criteria: Patients will be excluded from the study if they have received prior systemic therapy for the treatment of metastatic colorectal carcinoma or antiEGFR therapy, with the exception of adjuvant fluoropyrimidine-based chemotherapy given at least six months prior to enrolment or oxaliplatin at least 12 months prior to enrolment. Systemic chemotherapy, hormonal therapy, immunotherapy or experimental or approved proteins/antibodies (eg, bevacizumab) ≤ 30 days before inclusion Unresolved toxicities from prior systemic therapy that, in the opinion of the investigator, does not qualify the patient for inclusion Patients cognitively impaired or with severe depression according mini mental state examination and geriatric depression scale. Patients with central nervous system metastases, or those with significant cardiovascular disease, will also be excluded. History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline chest CT scan Treatment for systemic infection within 14 days before initiating study treatment Radiotherapy < 14 days prior to inclusion in the study. Active inflammatory bowel disease or other bowel disease causing chronic diarrhoea (defined as > 4 loose stools per day) History of any medical condition that may increase the risks associated with study participation or may interfere with the interpretation of the study results Known positive test for human immunodeficiency virus infection, hepatitis C virus, chronic active hepatitis B infection subject allergic to the ingredients of the study medication or to Staphylococcus protein A Any co-morbid disease that would increase risk of toxicity Any investigational agent within 30 days before enrolment Must not have had a major surgical procedure within 28 days of enrolment Subject unwilling or unable to comply with study requirements

Ages Eligible for Study
-----------------
Minimum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Panitumumab<br>Panitumumab: 6 mg/Kg Q2W Treatment cycles repeated every 14 days. Subjects will be evaluated for tumour response every 3 cycles (6 wks ± 1 wk) the first 24 weeks and every 8 weeks ± 2 weeks thereafter (per the revised-RECIST 1.1 guideline) until PD or withdrawal from the trial. | Biological: Panitumumab<br>* Panitumumab: 6 mg/Kg Q2W<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival rate at 6 months |  | May 2010 - March 2012 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | May 2010 - March 2012 | 
| Objective Response Rate |  | May 2010 - March 2012 | 
| Disease control rate |  | May 2010 - March 2012 | 
| Time to response |  | May 2010 - March 2012 | 
| Time to progression |  | May 2010 - March 2012 | 
| Time to treatment failure |  | May 2010 - March 2012 | 
| Duration of response |  | May 2010 - March 2012 | 
| Duration of stable disease |  | May 2010 - March 2012 | 
| Overall survival |  | May 2010 - March 2012 | 
| Changes in patient-reported outcomes |  | May 2010 - March 2012 | 
| Adverse events |  | May 2010 - March 2012 | 
| Evaluation of molecular predictive markers for response. |  | May 2010 - March 2012 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
advanced colorectal cancer; K-RAS; panitumumab, advanced Wild Type K-RAS colorectal cancer