UNRESECTABLE KRAS WILD-TYPE METASTATIC COLORECTAL CANCER PATIENTS MedDRA version: 14.1 Level: LLT Classification code 10050035 Term: Metastatic colon cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: IRINOTECAN TEVA*1FL 100MG 5ML
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: NA
CAS Number: 97682-44-5
Current Sponsor code: NA
Other descriptive name: NA
Sponsors
G.O.N.O. - GRUPPO ONCOLOGICO NORD OVEST
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Histologically confirmed colorectal adenocarcinoma; ? Availability of formalin-fixed paraffin embedded tumor block from primary and/or metastasis; ? KRAS wild-type status of primary colorectal cancer or related metastasis; ? Unresectable and measurable metastatic disease according to RECIST criteria; ? Male or female, aged > 18 years and =65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: ? Prior palliative chemotherapy; ? Prior treatment with EGFR or VEGF inhibitors; ? Symptomatic peripheral neuropathy > 2 grade NCIC-CTG criteria; ? Presence or history of CNS metastasis; ? Active uncontrolled infections; active disseminated intravascular coagulation; ? Past or current history of malignancies other than colorectal carcinoma, except for curatively treated basal and squamous cell carcinoma of the skin cancer or in situ carcinoma of the cervix; ? Clinically significant cardiovascular disease: cerebrovascular accidents or myocardial infarction in the 12 months before treatment start, unstable angina, grade 2 NYHA chronic heart failure, uncontrolled arrhythmia, uncontrolled hypertension; ? Serious, non-healing wound, ulcer, or bone fracture; ? Evidence of bleeding diathesis or coagulopathy; ? Major surgical procedure or significant traumatic injury within 28 days prior to study treatment start; ? Current or recent (within 10 days prior to study treatment start) ongoing treatment with anticoagulants for therapeutic purposes or chronic, daily treatment with high-dose aspirin (>325 mg/day); ? Subtotal colectomy, malabsorption syndrome and chronic inflammatory bowel disease (i.e. ulcerative colitis, Chron syndrome); ? Fertile women (<2 years after last menstruation) and men of childbearing potential not willing to use effective means of contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 10 months-Progression Free Rate (10m-PFR);Secondary Objective: • Response rate, • Resection Rate, • Time to strategy failure, • Time to 2nd PD, • Progression Free Survival (PFS), • Overall Survival (OS), • Safety profile;Primary end point(s): 10 months-Progression Free Rate (10m-PFR);Timepoint(s) of evaluation of this end point: 18 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -;Timepoint(s) of evaluation of this end point: 18 months | — |
Countries
Italy
Contacts
Public ContactU.O. Oncologia Medica 2
AOUP Pisa
Outcome results
None listed