Locally advanced or metastatic cancer of the colon or rectum MedDRA version: 9.1 Level: LLT Classification code 10061451 Term: Colorectal cancer
Conditions
Sponsors
ROCHE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologically or cytologically proven diagnosis of colorectal cancer - Locally advanced or metastatic colorectal cancer not previously treated with chemotherapy for metastatic disease - Age ≥ 18 - ECOG Performance Status 0-1 (Appendix III) - Life expectancy of at least 12 weeks - At least one measurable lesion according to RECIST criteria - Neutrophils ≥1.5 x 109/L and Platelets ≥100 x 109/L - Total bilirubin ≤1.5 time the upper-normal limits (UNL) of the Institutional normal values and ASAT (SGOT) and/or ALAT (SGPT) ≤2.5 x UNL, or ≤5 x UNL in case of liver metastases, alkaline phosphatase ≤2.5 x UNL, ≤5 x UNL in case of liver metastases. - Creatinine clearance >50 mL/min or serum creatinine ≤1.5 x UNL - Urine dipstick of proteinuria =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Radiotherapy to any site within 4 weeks before the study. - Untreated brain metastases or spinal cord compression or primary brain tumours. - History or evidence upon physical examination of CNS disease unless adequately treated (e.g., seizure not controlled with standard medical therapy or history of stroke). - Serious, non-healing wound, ulcer, or bone fracture. - Evidence of bleeding diathesis or coagulopathy. - Uncontrolled hypertension. - 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. - Current or recent (within 10 days prior to study treatment start) ongoing treatment with anticoagulants for therapeutic purposes. - Chronic, daily treatment with high-dose aspirin (>325 mg/day). - Treatment with any investigational drug within 30 days prior to enrolment. - Patients with known allergy to Chinese hamster ovary cell proteins, or any of the components of the study medications. - Other co-existing malignancies or malignancies diagnosed within the last 5 years. - 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. - Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medication. - 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 nonchildbearing potential. Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study. - Symptomatic peripheral neuropathy ≥grade 1 according the NCI Common Toxicity Criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To confirm the efficacy of bevacizumab in combination with oxaliplatin and capecitabine (XELOX) based regimen, based on progression free survival;Secondary Objective: - To evaluate the safety profile of bevacizumab in combination with oxaliplatin and capecitabine (XELOX) based regimen. - To determine the overall response rate, time to response, duration of response, overall survival rate, percentage of R0 resectability of metastatic lesions and quality of life of patients treated with bevacizumab in combination with oxaliplatin and capecitabine (XELOX);Primary end point(s): Progression free survival (PFS), defined as the time period from the start of study medication to disease progression or death from any cause. | — |
Countries
Italy
Outcome results
None listed