Clinical trial NCT01126112: Study 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Cancer
Keywords: advanced colorectal cancer; K-RAS; panitumumab
advanced Wild Type K-RAS colorectal cancer
Lead sponsor: Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
Sponsor class: OTHER
Collaborators: name: Amgen
First posted: 2010-05-19
Enrollment: 33
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Progression-free survival rate at 6 months
timeFrame: May 2010 - March 2012
Secondary outcomes:
measure: Progression-free survival
timeFrame: May 2010 - March 2012
measure: Objective Response Rate
timeFrame: May 2010 - March 2012
measure: Disease control rate
timeFrame: May 2010 - March 2012
measure: Time to response
timeFrame: May 2010 - March 2012
measure: Time to progression
timeFrame: May 2010 - March 2012
measure: Time to treatment failure
timeFrame: May 2010 - March 2012
measure: Duration of response
timeFrame: May 2010 - March 2012
measure: Duration of stable disease
timeFrame: May 2010 - March 2012
measure: Overall survival
timeFrame: May 2010 - March 2012
measure: Changes in patient-reported outcomes
timeFrame: May 2010 - March 2012
measure: Adverse events
timeFrame: May 2010 - March 2012
measure: Evaluation of molecular predictive markers for response.
timeFrame: May 2010 - March 2012
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Spanish Cooperative Group for Gastrointestinal Tumour Therapy
Study officials:
affiliation: Hospital Universitario Clínico San Carlos. Madrid. Spain
name: Javier Sastre
role: STUDY_CHAIR
References:
citation: Sastre J, Massuti B, Pulido G, Guillen-Ponce C, Benavides M, Manzano JL, Reboredo M, Rivera F, Gravalos C, Safont MJ, Martinez Villacampa M, Llovet P, Dotor E, Diaz-Rubio E, Aranda E; Spanish Cooperative Group for the Treatment of Digestive Tumours TTD. First-line single-agent panitumumab in frail elderly patients with wild-type KRAS metastatic colorectal cancer and poor prognostic factors: A phase II study of the Spanish Cooperative Group for the Treatment of Digestive Tumours. Eur J Cancer. 2015 Jul;51(11):1371-80. doi: 10.1016/j.ejca.2015.04.013. Epub 2015 May 8.