NCT01126112CompletedPhase 2
Phase II Study of First-line Single-agent Panitumumab in Frail Elderly Patients With Advanced Wild Type K-RAS Colorectal Cancer
Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)1 site in 1 country33 target enrollmentStarted: May 1, 2010Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- Progression-free survival rate at 6 months
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 70 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Panitumumab (Biological)
Outcomes
Primary Outcomes
Progression-free survival rate at 6 months
Time Frame: May 2010 - March 2012
Secondary Outcomes
- 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)
- Time to treatment failure(May 2010 - March 2012)
- Duration of response(May 2010 - March 2012)
- Duration of stable disease(May 2010 - March 2012)
- Overall survival(May 2010 - March 2012)
- Changes in patient-reported outcomes(May 2010 - March 2012)
- Adverse events(May 2010 - March 2012)
- Evaluation of molecular predictive markers for response.(May 2010 - March 2012)
Investigators
Study Sites (1)
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