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

NCT01126112 | Completed Phase 2

• 2 other identifiers: TTD-09-032009-016661-28
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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

Conditions

Colorectal Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Progression-free survival rate at 6 months

  May 2010 - March 2012

Secondary Outcomes (12)

• 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

Study Arms (1)

Panitumumab

EXPERIMENTAL

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

Interventions

Panitumumab BIOLOGICAL

Panitumumab: 6 mg/Kg Q2W

Panitumumab

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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
• 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

Sponsors & Collaborators

• Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD): lead
• Amgen: collaborator

Study Sites (1)

Spanish Cooperative Group for Gastrointestinal Tumour Therapy

Madrid, 28046, Spain

Location

Related Publications (1)

• 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.

  PMID: 25963019 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Panitumumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Javier Sastre

  Hospital Universitario Clínico San Carlos. Madrid. Spain

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2010
• First Posted: May 19, 2010
• Study Start: May 1, 2010
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: March 24, 2015

Record last verified: 2015-03

Locations

ES (1)