metastatic colorectal cancer
Conditions
Interventions
Trade Name: Avastin
Product Name: Avastin
Pharmaceutical Form: Concentrate for solution for injection
Trade Name: Xeloda
Product Name: Xeloda
Pharmaceutical Form: Tablet
Sponsors
Pia österlund and Helena Isoniemi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria 1. Patients with histologically confirmed diagnosis of CRC, chemotherapy naïve for metastatic disease (prior adjuvant chemotherapy more than 6 months previously for CRC allowed), who are scheduled to start first line chemotherapy for metastatic disease 2. Age ? 18 3. Measurable or evaluable metastatic disease 4. Performance status ECOG performance status 0-2 5. Life expectancy greater than 3 months 6. Thrombocytes ? 100’000/?l, neutrophils ? 1’500/µl, Aspartate amino transferase/Alanine amino transferase ? 2.5 ? Upper limit of normal (ULN) (= 5 ? ULN if liver metastases present), Alkaline phosphatase ? 2.5 ? ULN (= 5 ? ULN if liver metastases present), Serum bilirubin ? 1.5 ? ULN, Serum Creatinine ? 1.5 ? ULN, Urine dipstick of proteinuria =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria 1. Prior treatment with first-line chemotherapy for metastatic CRC 2. Adjuvant treatment within 6 months 3. Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to Day 0 (Patients must have recovered from any major surgery) 4. Near future planned radiotherapy for underlying disease (prior completed radiotherapy treatment allowed) 5. Clinical or radiological evidence of CNS metastases 6. Past or current history within the last 2 years of malignancies except for the indication under this study and curatively treated basal and squamous cell carcinoma of the skin or in-situ carcinoma of the cervix 7. Serious non-healing wound or ulcer 8. Evidence of bleeding diathesis or coagulopathy 9. Uncontrolled hypertension 10. 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 11. Treatment with any investigational drug 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 the treatment or patient at high risk from treatment complications 13. Chronic daily intake of aspirin (> 325 mg/day) or clopidogren (> 75 mg/day) 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: - PFS - To assess overall resectability in patients with metastatic colorectal cancer, postoperative morbidity and outcomes after resection ;Secondary Objective: - To assess response rates according to RECIST criteria, failure free survival (TTF) and overall survival (OS) - Quality of life according to 15D questionnaire - To radiologically assess tumor density and morphology, and assess alternative radiologic response evaluation in comparison with RECIST response criteria - Biomarker evaluation to measure plasma biomarkers, tumor blocks and DNA polymorphisms that may predict drug effects, safety, and clinical behavior of the tumor ;Primary end point(s): PFS, resectability rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - response rates, failure free survival (TTF) and overall survival (OS) - Quality of life stionnaire - tumor density and morphology and alternative radiologic response evaluation - Biomarker evaluation | — |
Countries
Finland
Contacts
Public ContactHelsinki University Hospital
Pia Österlund
Outcome results
None listed