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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Spanish Cooperative Group for Digestive Tumour Therapy (TTD)
ClinicalTrials.gov Identifier:
NCT01126112
First received: May 17, 2010
Last updated: March 26, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Colorectal Cancer
Biological: Panitumumab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Spanish Cooperative Group for Digestive Tumour Therapy (TTD):

Primary Outcome Measures:
  • Progression-free survival rate at 6 months [ Time Frame: May 2010 - March 2012 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: May 2010 - March 2012 ] [ Designated as safety issue: No ]
  • Objective Response Rate [ Time Frame: May 2010 - March 2012 ] [ Designated as safety issue: No ]
  • Disease control rate [ Time Frame: May 2010 - March 2012 ] [ Designated as safety issue: No ]
  • Time to response [ Time Frame: May 2010 - March 2012 ] [ Designated as safety issue: No ]
  • Time to progression [ Time Frame: May 2010 - March 2012 ] [ Designated as safety issue: No ]
  • Time to treatment failure [ Time Frame: May 2010 - March 2012 ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: May 2010 - March 2012 ] [ Designated as safety issue: No ]
  • Duration of stable disease [ Time Frame: May 2010 - March 2012 ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: May 2010 - March 2012 ] [ Designated as safety issue: No ]
  • Changes in patient-reported outcomes [ Time Frame: May 2010 - March 2012 ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: May 2010 - March 2012 ] [ Designated as safety issue: Yes ]
  • Evaluation of molecular predictive markers for response. [ Time Frame: May 2010 - March 2012 ] [ Designated as safety issue: No ]

Estimated Enrollment: 33
Study Start Date: May 2010
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01126112

Locations
Spain
Spanish Cooperative Group for Gastrointestinal Tumour Therapy
Madrid, Spain, 28046
Sponsors and Collaborators
Spanish Cooperative Group for Digestive Tumour Therapy (TTD)
Amgen
Investigators
Study Chair: Javier Sastre Hospital Universitario Clínico San Carlos. Madrid. Spain
  More Information

Additional Information:
No publications provided

Responsible Party: Spanish Cooperative Group for Digestive Tumour Therapy (TTD)
ClinicalTrials.gov Identifier: NCT01126112     History of Changes
Other Study ID Numbers: TTD-09-03, 2009-016661-28
Study First Received: May 17, 2010
Last Updated: March 26, 2014
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Spanish Cooperative Group for Digestive Tumour Therapy (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
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014