Study of First-line Single-agent Panitumumab in Frail Elderly Patients With Advanced Wild Type K-… (NCT01126112) | Clinical Trial Compass
CompletedPhase 2
Study of First-line Single-agent Panitumumab in Frail Elderly Patients With Advanced Wild Type K-RAS Colorectal Cancer
Spain33 participantsStarted 2010-05
Plain-language 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
Who can participate
Age range70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Progression-free survival rate at 6 months
Timeframe: May 2010 - March 2012
Trial details
NCT IDNCT01126112
SponsorSpanish Cooperative Group for the Treatment of Digestive Tumours (TTD)