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

• ClinicalTrials.gov Identifier: NCT01126112
• Recruitment Status: Completed
• First Posted: May 19, 2010
• Last Update Posted: March 24, 2015
• Sponsor: Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
• Collaborator: Amgen
• Information provided by (Responsible Party): Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)

Study Description

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

Condition or disease	Intervention/treatment	Phase
Colorectal Cancer	Biological: Panitumumab	Phase 2

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 33 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Study of First-line Single-agent Panitumumab in Frail Elderly Patients With Advanced Wild Type K-RAS Colorectal Cancer
• Study Start Date: May 2010
• Actual Primary Completion Date: July 2014
• Actual Study Completion Date: July 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: Panitumumab; 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; Panitumumab: 6 mg/Kg Q2W

Outcome Measures

Primary Outcome Measures :

1. Progression-free survival rate at 6 months [ Time Frame: May 2010 - March 2012 ]

Secondary Outcome Measures :

1. Progression-free survival [ Time Frame: May 2010 - March 2012 ]
2. Objective Response Rate [ Time Frame: May 2010 - March 2012 ]
3. Disease control rate [ Time Frame: May 2010 - March 2012 ]
4. Time to response [ Time Frame: May 2010 - March 2012 ]
5. Time to progression [ Time Frame: May 2010 - March 2012 ]
6. Time to treatment failure [ Time Frame: May 2010 - March 2012 ]
7. Duration of response [ Time Frame: May 2010 - March 2012 ]
8. Duration of stable disease [ Time Frame: May 2010 - March 2012 ]
9. Overall survival [ Time Frame: May 2010 - March 2012 ]
10. Changes in patient-reported outcomes [ Time Frame: May 2010 - March 2012 ]
11. Adverse events [ Time Frame: May 2010 - March 2012 ]
12. Evaluation of molecular predictive markers for response. [ Time Frame: May 2010 - March 2012 ]

Eligibility Criteria

• Ages Eligible for Study: 70 Years and older (Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Spain

Spanish Cooperative Group for Gastrointestinal Tumour Therapy

Madrid, Spain, 28046

Sponsors and Collaborators

Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)

Amgen

Investigators

• Study Chair: Javier Sastre; Hospital Universitario Clínico San Carlos. Madrid. Spain

More Information

Additional Information:

Related Info 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Sastre J, Massuti B, Pulido G, Guillén-Ponce C, Benavides M, Manzano JL, Reboredo M, Rivera F, Grávalos C, Safont MJ, Martínez Villacampa M, Llovet P, Dotor E, Díaz-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.

• Responsible Party: Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
• ClinicalTrials.gov Identifier: NCT01126112
• Other Study ID Numbers: TTD-09-03; 2009-016661-28 ( EudraCT Number )
• First Posted: May 19, 2010
• Last Update Posted: March 24, 2015
• Last Verified: March 2015

Keywords provided by Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD):

advanced colorectal cancer; K-RAS; panitumumab; advanced Wild Type K-RAS colorectal cancer

Additional relevant MeSH terms:

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Panitumumab; Antineoplastic Agents, Immunological; Antineoplastic Agents