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

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ClinicalTrials.gov Identifier: NCT01126112
Recruitment Status : Completed
First Posted : May 19, 2010
Last Update Posted : March 24, 2015
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)

Tracking Information
First Submitted Date  ICMJE May 17, 2010
First Posted Date  ICMJE May 19, 2010
Last Update Posted Date March 24, 2015
Study Start Date  ICMJE May 2010
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 18, 2010)
Progression-free survival rate at 6 months [ Time Frame: May 2010 - March 2012 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 18, 2010)
  • Progression-free survival [ Time Frame: May 2010 - March 2012 ]
  • Objective Response Rate [ Time Frame: May 2010 - March 2012 ]
  • Disease control rate [ Time Frame: May 2010 - March 2012 ]
  • Time to response [ Time Frame: May 2010 - March 2012 ]
  • Time to progression [ Time Frame: May 2010 - March 2012 ]
  • Time to treatment failure [ Time Frame: May 2010 - March 2012 ]
  • Duration of response [ Time Frame: May 2010 - March 2012 ]
  • Duration of stable disease [ Time Frame: May 2010 - March 2012 ]
  • Overall survival [ Time Frame: May 2010 - March 2012 ]
  • Changes in patient-reported outcomes [ Time Frame: May 2010 - March 2012 ]
  • Adverse events [ Time Frame: May 2010 - March 2012 ]
  • Evaluation of molecular predictive markers for response. [ Time Frame: May 2010 - March 2012 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of First-line Single-agent Panitumumab in Frail Elderly Patients With Advanced Wild Type K-RAS Colorectal Cancer
Official Title  ICMJE Phase II Study of First-line Single-agent Panitumumab in Frail Elderly Patients With Advanced Wild Type K-RAS Colorectal Cancer
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE Biological: Panitumumab
Panitumumab: 6 mg/Kg Q2W
Study Arms  ICMJE 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.
Intervention: Biological: Panitumumab
Publications * Sastre J, Massuti B, Pulido G, Guillén-Ponce C, Benavides M, Manzano JL, Reboredo M, Rivera F, Grávalos C, Safont MJ, Martínez Villacampa M, Llovet P, Dotor E, Díaz-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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 18, 2010)
33
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 70 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01126112
Other Study ID Numbers  ICMJE TTD-09-03
2009-016661-28 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
Study Sponsor  ICMJE Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
Collaborators  ICMJE Amgen
Investigators  ICMJE
Study Chair: Javier Sastre Hospital Universitario Clínico San Carlos. Madrid. Spain
PRS Account Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP