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 enrollmentMay 2010

ConditionsColorectal Cancer

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Colorectal Cancer
Sponsor: Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
Enrollment: 33
Locations: 1
Primary Endpoint: Progression-free survival rate at 6 months
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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

Registry

clinicaltrials.gov

Start Date

May 2010

End Date

July 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)

Responsible Party

Sponsor

Eligibility Criteria

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:

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