Status:
UNKNOWN
Neo-adjuvant Therapy and the Effect on Synchronous Metastatic Growth
Lead Sponsor:
Radboud University Medical Center
Conditions:
Colorectal Neoplasms
Liver Neoplasms
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
Study Hypothesis • As well as in animal models as in patients with colorectal cancer resection of the primary tumor resulted in increase in vascular density, metabolism and secondary tumor growth of ...
Eligibility Criteria
Inclusion
- Patients with histological proven primary colorectal cancer and synchronous unresectable liver metastases with or without additional extrahepatic disease (primary tumor in situ). Unresectable liver metastases defined as too extensive hepatic involvement or extrahepatic disease.
- Measurable liver metastases on CT scan (RECIST), positive signal of liver metastases on FDG-PET scan
- Age: 18-80 years
- WHO performance scale 0-1
- ASA category I or II
- Negative pregnancy test in women with childbearing potential
- Life expectancy \> 12 weeks
- Laboratory values obtained ≤ 3 weeks prior to study entry, disease evaluation performed ≤ 3 weeks prior to study entry. Adequate bone marrow function (Hb \> 6.5 mmol/L, absolute neutrophil count \> 1.5 x 109/L, platelets \> 100 x 109/L), renal function (serum creatinine \< 1.5 x ULN or creatinine clearance ≥ 50 mL/min (calculated according to Cockroft and Gault), liver function (ASAT and ALAT ≤ 3 x upper normal limit, serum bilirubin ≤ 2 x upper normal limit)
- Written informed consent
Exclusion
- Signs of bowel obstruction or bleeding from primary tumor
- Prior chemotherapy treatment for advanced disease, prior treatment with anti-angiogenic drugs
- Resectable liver metastases
- Diabetes mellitus
- Continuous use of immunosuppressive agents
- Pregnancy or lactation
- Contra-indications for systemic therapy with bevacizumab (Avastin)/ chemotherapy (Xelox)
- Concurrent severe or uncontrolled disease (i.e. uncontrolled hypertension, congestive heart failure, myocardial infarction \< 12 months, chronic active infection)
- Sensory neuropathy \> grade 1
- Serious non-healing wound or ulcer
- Patients (M/F) with reproductive potential not implementing adequate contraceptive measures
- Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to start of bevacizumab
- Bleeding disorders or coagulopathy or need for full-dose anticoagulation
- Signs or symptoms of brain metastases
- Cerebrovascular accident or transient ischemic attack within the past 12 months
- Impairment of gastrointestinal function or -disease that may significantly impair the absorption of oral drugs (i.e. uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, bowel obstruction, or inability to swallow tablets)
- Presence of proteinuria at baseline as defined by: patients with \> 1 g of protein/24 hr by a 24-hour urine collection.
- Any concomitant disorder preventing the safe administration of study drugs or surgical procedure.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2014
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00659022
Start Date
July 1 2008
End Date
April 1 2014
Last Update
September 12 2011
Active Locations (2)
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1
The Netherlands Cancer Institute/ Antoni van Leeuwenhoek Hospital
Amsterdam, Netherlands, 1066 CX
2
Radboud University Nijmegen Medical Center
Nijmegen, Netherlands, 6500 HB