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

Phase 2
70 Years
Open (Enrolling)
Colorectal Cancer

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Trial Information

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

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

Inclusion Criteria:

- Signed Inform Consent

- Age > 70 years.

- Histologically documented metastatic colorectal cancer not candidate for surgical

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival rate at 6 months

Outcome Time Frame:

May 2010 - March 2012

Safety Issue:


Principal Investigator

Javier Sastre

Investigator Role:

Study Chair

Investigator Affiliation:

Hospital Universitario Clínico San Carlos. Madrid. Spain


Spain: Spanish Agency of Medicines

Study ID:




Start Date:

May 2010

Completion Date:

February 2013

Related Keywords:

  • Colorectal Cancer
  • advanced colorectal cancer; K-RAS; panitumumab
  • advanced Wild Type K-RAS colorectal cancer
  • Colorectal Neoplasms