Status:
COMPLETED
Induction Chemoterapy With Folfoxiri Plus Cetuxumab in Unresectable Colorectal Cancer Patient
Lead Sponsor:
Gruppo Oncologico del Nord-Ovest
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This is a phase II randomized study of 4-months induction first-line chemotherapy with FOLFOXIRI + cetuximab followed by maintenance with cetuximab or bevacizumab in patients affected by KRAS wild typ...
Detailed Description
The aim of the study is to obtain a rapid disease control with the therapy and the maximum tumoral shrinkage, and than to treat patient with less intensive maintenance to inhibit tumoral regrowth.
Eligibility Criteria
Inclusion
- 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 \< 75 years;
- ECOG PS \< 2 if aged \< 71 years, ECOG PS = 0 if aged 71-75 years;
- Life expectancy of more than 3 months;
- Adequate haematological function: ANC ≥ 1.5 x 109/L; platelets ≥ 100 x 109/L, Hb ≥ 9 g/dL;
- Adequate liver and renal function: serum bilirubin ≤ 1.5 x ULN; alkaline phosphatase and transaminases ≤ 2.5 x ULN (in case of liver metastases \< 5 x ULN); serum creatinine ≤ 1.5 x ULN;
- Previous adjuvant chemotherapy containing oxaliplatin is allowed if more than 12 months have elapsed between the end of adjuvant therapy and first relapse;
- Previous adjuvant chemotherapy with fluoropyrimidine monotherapy is allowed if more than 6 months have elapsed between the end of adjuvant and first relapse;
- At least 6 weeks from prior extended radiotherapy and 4 weeks from surgery;
- Written informed consent to experimental treatment and KRAS analysis.
Exclusion
- 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 ≤ 12 months before treatment start, unstable angina, NYHA ≥ grade 2 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.
- Psychiatric disorder precluding understanding of information on trial related topics,
- Serious underlying medical condition (judged by the investigator) which could impair the ability of the patient to participate in the trial (e.g. uncontrolled diabetes mellitus, active autoimmune disease)
- Concurrent treatment with other experimental drugs or other anti-cancer therapy; treatment in a clinical trial within 30 days prior to trial entry
- Definite contraindications for the use of corticosteroids and antihistamines as premedication
- Known hypersensitivity to trial drugs or hypersensitivity to any other component of the trial drugs
- Any concomitant drugs contraindicated for use with the trial drugs according to the product information of the pharmaceutical companies
- Pregnancy
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- Medical or psychological condition which, in the opinion of the investigator, would not permit the patient to complete the study or sign meaningful informed consent
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
143 Patients enrolled
Trial Details
Trial ID
NCT02295930
Start Date
October 1 2011
Last Update
March 12 2015
Active Locations (22)
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1
A.O.Universitaria Policlinico S.Orsola-Malpighi Di Bologna (Oncologia Medica)
Bologna, Italy, Italy, 40138
2
AUSL DI FROSINONE - FROSINONE (FR) ONCOLOGIA MEDICA U.O. Oncologia Medica
Frosinone, Italy, Italy, 03100
3
Ausl 12 Di Viareggio (Lu) - Lido Di Camaiore (Lu) Oncologia Medica
Lucca, Italy, Italy, 50053
4
AZIENDA OSPEDALIERA DI PERUGIA - OSPEDALE S. MARIA DELLA MISERICORDIA - PERUGIA (PG) ONCOLOGIA MEDICA U.O. Oncologia Medica
Perugia, Italy, Italy, 06156