Open, Multicenter Phase II Study to Evaluate the Efficacy and Safety of the Combination of Panitumumab With Irinotecan in Patients With Wild-Type KRAS Metastatic Colorectal Cancer Refractory to Irinotecan Based Chemotherapy

Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)1 site in 1 country61 target enrollmentAugust 2009

ConditionsMetastatic Colorectal Cancer

InterventionsPanitumumab+irinotecan

DrugsPanitumumab+irinotecan

Overview

Phase: Phase 2
Intervention: Panitumumab+irinotecan
Conditions: Metastatic Colorectal Cancer
Sponsor: Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
Enrollment: 61
Locations: 1
Primary Endpoint: Objective response rate
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the study is to evaluate the efficacy and safety of the combination of Panitumumab with Irinotecan in patients with Wild-Type KRAS metastatic colorectal cancer refractory to irinotecan based chemotherapy.

Registry

clinicaltrials.gov

Start Date

August 2009

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

•Competent to comprehend, sign, and date an IEC-approved informed consent form.
•Men or women 18 years of age or older at the time the written informed consent is obtained.
•Histologically confirmed metastatic adenocarcinoma of the colon or rectum
•Wild-Type KRAS (No mutation) by allelic discrimination on tumor DNA.
•Karnofsky performance status ≥ 70% at the time of enrolment in the study.
•Within seven days prior to initiating study treatment:
•Adequate bone marrow function: neutrophils ≥ 1.5x109/ L; platelets ≥ 100x109/L; hemoglobin ≥ 9g/dL.
•Hepatic functions as follows: total bilirubin count ≤ 1.5 x ULN; ALAT and ASAT ≤ 2.5 x ULN (≤5 x ULN in case of liver metastasis).
•Renal function: serum creatinine ≤1.5 ULN
•Metabolic functions: magnesium ≥ lower limit of normal (LLN), calcium ≥ lower limit of normal (LLN)

Exclusion Criteria

•Prior malignant tumor in the last 5 years, except a history of basal cell carcinoma of the skin or pre-invasive cervical cancer.
•Unresolved toxicities from prior systemic therapy that, in the opinion of the investigator, does not qualify the patient for inclusion.
•Documented or suspected central nervous system metastases.
•Hormonal therapy, immunotherapy or experimental or approved proteins/antibodies (eg, Bevacizumab) ≤ 30 days before inclusion.
•Significant cardiovascular disease including unstable angina or myocardial infarction within 12 months before initiating study treatment or a history of ventricular arrhythmia.
•Prior anti-EGFr antibody therapy (eg, Cetuximab) or treatment small molecule EGFr tyrosine kinase inhibitors (eg, Erlotinib) or EGFR signal transduction inhibitors. Subjects who discontinue their first dose of anti-EGFR therapy (Cetuximab) because of an infusion reaction may participate in this clinical trial.
•Paraffin-embedded tissue or unstained tumor slides from primary or metastatic tumor not available (blocks available for Translational research).
•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.
•Acute or sub-acute intestinal occlusion and /or active inflammatory bowel disease or other bowel disease causing chronic diarrhoea (defined as \> 4 loose stools per day).