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

NCT ID: NCT01126112

Last Updated: 2015-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2014-07-31

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

Conditions

Colorectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Panitumumab

Intervention Type: BIOLOGICAL

Panitumumab: 6 mg/Kg Q2W

Interventions

Panitumumab

Panitumumab: 6 mg/Kg Q2W

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Javier Sastre

Role: STUDY_CHAIR

Hospital Universitario Clínico San Carlos. Madrid. Spain

Locations

Spanish Cooperative Group for Gastrointestinal Tumour Therapy

Madrid, , Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 25963019 (View on PubMed)

Related Links

http://www.ttdgroup.org

Related Info

Other Identifiers

2009-016661-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

TTD-09-03

Identifier Type: -

Identifier Source: org_study_id