Study of First-line Single-agent Panitumumab in Frail Elderly Patients With Advanced Wild Type K-RAS Colorectal Cancer (FRAIL)
March 23, 2015 updated by: Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
Phase II Study of First-line Single-agent Panitumumab in Frail Elderly Patients With Advanced Wild Type K-RAS Colorectal Cancer
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 Overview
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 Type
Interventional
Enrollment (Actual)
33
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Madrid, Spain, 28046
- Spanish Cooperative Group for Gastrointestinal Tumour Therapy
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
70 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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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.
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Panitumumab: 6 mg/Kg Q2W
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Progression-free survival rate at 6 months
Time Frame: May 2010 - March 2012
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May 2010 - March 2012
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Progression-free survival
Time Frame: May 2010 - March 2012
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May 2010 - March 2012
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Objective Response Rate
Time Frame: May 2010 - March 2012
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May 2010 - March 2012
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Disease control rate
Time Frame: May 2010 - March 2012
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May 2010 - March 2012
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Time to response
Time Frame: May 2010 - March 2012
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May 2010 - March 2012
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Time to progression
Time Frame: May 2010 - March 2012
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May 2010 - March 2012
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Time to treatment failure
Time Frame: May 2010 - March 2012
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May 2010 - March 2012
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Duration of response
Time Frame: May 2010 - March 2012
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May 2010 - March 2012
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Duration of stable disease
Time Frame: May 2010 - March 2012
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May 2010 - March 2012
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Overall survival
Time Frame: May 2010 - March 2012
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May 2010 - March 2012
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Changes in patient-reported outcomes
Time Frame: May 2010 - March 2012
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May 2010 - March 2012
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Adverse events
Time Frame: May 2010 - March 2012
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May 2010 - March 2012
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Evaluation of molecular predictive markers for response.
Time Frame: May 2010 - March 2012
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May 2010 - March 2012
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: Javier Sastre, Hospital Universitario Clínico San Carlos. Madrid. Spain
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2010
Primary Completion (Actual)
July 1, 2014
Study Completion (Actual)
July 1, 2014
Study Registration Dates
First Submitted
May 17, 2010
First Submitted That Met QC Criteria
May 18, 2010
First Posted (Estimate)
May 19, 2010
Study Record Updates
Last Update Posted (Estimate)
March 24, 2015
Last Update Submitted That Met QC Criteria
March 23, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TTD-09-03
- 2009-016661-28 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.