Metastatic cancer of the colon or rectum.
Conditions
Sponsors
F.Hoffmann-La Roche Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with histologically confirmed diagnosis of metastatic CRC, untreated yet with chemotherapy for metastatic disease (prior adjuvant chemotherapy for colorectal cancer allowed), who are scheduled to start first line fluoropyrimidine-based chemotherapeutic treatment. 2. Age = 18. 3. Measurable or non-measurable disease. 4. Performance status ECOG performance status 0 or 1. 5. Life expectancy greater than 3 months. 6. Neutrophils = 1’500/µl, Platelets = 100’000/µl, AST/ALT = 2.5 × ULN (=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Treatment with first-line chemotherapy for metastatic CRC. 2. Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to Day 0 (Patients must have recovered from any major surgery), or anticipation of need for major surgical procedure during the course of the study. 3. Planned radiotherapy for underlying disease (prior completed radiotherapy treatment allowed). 4. Clinical or radiological evidence of CNS metastases. 5. Past or current history (within the last 5 years) of malignancies except for the indication under this study and curatively treated: - Basal and squamous cell carcinoma of the skin - In-situ carcinoma of the cervix 6. Serious non-healing wound or ulcer. 7. Evidence of bleeding diathesis or coagulopathy. 8. Uncontrolled hypertension. 9. 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. 10. Current or recent (within 10 days prior to study treatment start) ongoing treatment with anticoagulants for therapeutic purposes i.e. except for anticoagulation for maintenance of patency of permanent indwelling IV catheters. 11. Treatment with any investigational drug (including IMMP, EGFR inhibitors, COX-2 inhibitors) or participation in another investigational study within 30 days prior to enrolment. 12. Evidence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or patient at high risk from treatment complications 13. Ongoing treatment with aspirin (> 325 mg/day) or other medications known to predispose to gastrointestinal ulceration 14. Pregnancy (positive serum pregnancy test) and lactation 15. Any other serious or uncontrolled illness which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety profile of bevacizumab when combined with fluoropyrimidine-based chemotherapy regimens as first line treatment of metastatic cancer of the colon or rectum. ;Secondary Objective: To assess the effectiveness of bevacizumab as measured by time to disease progression and duration of survival.;Primary end point(s): The intent to treat (ITT) population, which includes all patients receiving at least one dose of study drug, will be used for reporting the safety information. All safety parameters will be analysed and presented in terms of listings and summary tables. Adverse events and laboratory parameters will be assessed according to the National Cancer Institute Common Toxicity Criteria grading system (NCI CTC) (version 3.0, 2003). Adverse events will be displayed in standard frequency tables. For laboratory parameters, descriptive summary tables of change from baseline over time based on SI units will be produced. Shift tables of changes in NCI CTC grades will also be provided for laboratory parameters, with worst changes displayed. Descriptive summary tables of change from baseline over time will be provided for vital signs parameters. | — |
Countries
Hungary, Italy, Slovakia, Spain
Outcome results
None listed