First-line chemotherapy for patients with metastatic colorectal cancer MedDRA version: 14.1 Level: PT Classification code 10052358 Term: Colorectal cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Avastin
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Bevacizumab
Concentration unit: mg milligram(s)
Concentration number: 100-
Trade Name: Avastin
Pharmaceutical Form:
Sponsors
ROCHE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically proven diagnosis of colon or rectum with metastatic disease. 2. Patients must not have previously received systemic treatment for advanced disease. Adjuvant chemotherapy or neo-adjuvant treatment for non-metastatic disease (M0) is allowed if completed at least 6 months prior to initiation of the study treatment. If prior adjuvant therapy was received, patients must not have progressed during therapy or within 6 months of its completation. 3. Age >= 18 4. ECOG Performance Status 0-1 (Appendix I) 5. Life expectancy of at least 12 weeks 6. At least one target lesion with a minimum lesion size as per the RECIST criteria 7. Laboratory requirements: - Neutrophils >=1.5 x 109/L, Platelets >= 100 x 109/L, and Haemoglobin >= 10g/dL - Total bilirubin 50 mL/min or serum creatinine = 2+ proteinuria on dipstick urinalysis at baseline, should undergo a 24-hour urine collection and must demonstrate =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Radiotherapy to any site within 4 weeks before the study. 2. Symptomatic and/or unstable pre-existing brain metastases or leptomeningeal metastases requiring medication. 3. History of inflammatory bowel disease and/or acute/subacute bowel occlusion. 4. Serious non-healing wound or ulcer. 5. Evidence of bleeding diathesis or coagulopathy. 6. Uncontrolled hypertension. 7. Clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents (≤6 months), myocardial infarction (≤6 months), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication. 8. Current or recent (within 10 days prior to study treatment start) use of full-dose oral or parenteral anticoagulants for therapeutic purposes. 9. Chronic, daily treatment with high-dose aspirin (>325 mg/day) or other medications known to predispose to gastrointestinal ulceration. 10. Treatment with any investigational drug within 30 days prior to enrolment. 11. Patients with known allergy to Chinese hamster ovary cell proteins, or any of the components of the study medications 12. Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ 13. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start, or anticipation of the need for major surgical procedure during the course of the study. 14. Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medication. 15. Pregnant or lactating women. Women of childbearing potential with either a positive or no pregnancy test at baseline. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential. Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate, in terms of time to progression (TTP) or death, the non inferiority of each of three bevacizumab-containing chemotherapies.;Secondary Objective: - To evaluate and compare the toxicity and the safety profile of the three bevacizumab-containig chemotherapies; - To evaluate the response rate (RR), duration of response (DR), time to treatment failure (TTF), and overall survival (OS) in patients treated with each of three combinations.;Primary end point(s): Time to disease progression and best response rate. | — |
Countries
Italy
Outcome results
None listed