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Accelerated Growth of Synchronous Colorectal Liver Metastases: Effects of Neo-adjuvant Therapy

Phase 2
18 Years
80 Years
Open (Enrolling)
Colorectal Neoplasms, Liver Neoplasms

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Trial Information

Accelerated Growth of Synchronous Colorectal Liver Metastases: Effects of Neo-adjuvant Therapy

Inclusion Criteria:

- 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 Criteria:

- 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

- 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

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Difference in response of liver metastases between control group and experimental groups determined by histopathological scoring of vascular density,apoptotic and mitotic index

Outcome Time Frame:

12 weeks

Safety Issue:


Principal Investigator

Theo Ruers, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Netherlands Cancer Institute


Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:




Start Date:

July 2008

Completion Date:

April 2014

Related Keywords:

  • Colorectal Neoplasms
  • Liver Neoplasms
  • colorectal cancer
  • liver metastases
  • angiogenesis
  • metabolism
  • Neoplasms
  • Colorectal Neoplasms
  • Liver Neoplasms