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 range
70 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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)