A Randomised Two Arm Phase III Study in Patients Post Radical Resection of Liver Metastasis of Colorectal Cancer to Investigate Bevacizumab (q3w) in Combination With Capecitabine Plus Elaoxantin (XELOX) (q3w) as Adjuvant Chemotherapy vs XELOX (q3w) alone as Adjuvant Treatment - Hepatica

• Conditions: iver metastatis of colorectal cancer.

• Registration Number: EUCTR2006-006072-38-SE
• Lead Sponsor: the Dutch Colorectal Cancer Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09-21
• Last Update Posted: 5 August 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 620

Inclusion Criteria

1.Signed written informed consent obtained prior to any study-specific procedure.
2.Age = 18 years.
3.Liver metastases radically resected (R0 resection)
4.Study medication started =4 and = 8 weeks post liver surgery.
5.Histologically confirmed liver metastasis of colorectal cancer after surgery.
6.ECOG performance status 0 or 1 (Appendix 1).
7.Adequate hematology: neutrophils =1.5 x 109/L, platelets =100 x 109/L, Hb =5.5 mmol/L, INR = 1.5, APTT < 1.5 X UNL.
8.Adequate biochemistry: total bilirubin =1.5 UNL, ASAT and ALAT =2.5 x UNL, alkaline phosphatase =2.5 x UNL, serum creatinin =1.5 UNL.
9.Urine dipstick <2+ for protein.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1Extrahepatic metastatic disease.
2Adjuvant chemotherapy given <6 months prior to detection of the liver metastases.
3Chemotherapy for metastatic disease.
4Prior non colorectal malignancies, except adequately treated basalioma of the skin or carcinoma in situ of the cervix.
5Bleeding diathesis or coagulation disorders or the need for full-dose anticoagulation.
6Major surgical procedure <4 weeks prior to start of study treatment.
7Females with a positive pregnancy test (within 14 days before treatment start).
8Lactating women.
9Fertile women (<2 years after last menstruation) and women of childbearing potential not willing to use effective means of contraception.
10History of psychiatric disability judged by the investigator to be clinically significant, precluding informed consent or interfering with compliance for oral drug intake.
11Clinically significant (i.e. active) cardiovascular disease e.g. cerebrovascular accidents (=6 months prior to randomisation), myocardial infarction (=1 year prior to randomisation), uncontrolled hypertension while receiving chronic medication, unstable angina, New York Heart Association (NYHA) Grade II or greater congestive heart failure, or serious cardiac arrhytmia requiring medication.
12Lack of physical integrity of the upper gastro-intestinal tract, malabsorption syndrome, or inability to take oral medication.
13Known peripheral neuropathy, including oxaliplatin-induced neuropathy > grade 1. Absence of deep tendon reflexes as the sole neurological abnormality does not render the patient ineligible.
14Organ allografts requiring immunosuppressive therapy.
15Serious, non-healing wound, ulcer, or bone fracture.
16Current or recent (within 10 days prior to study treatment start) use of full-dose oral or parenteral anticoagulants or thrombolytic agent for therapeutic purposes.
17Chronic, daily treatment with high-dose asprin (>325 mg/day) or nonsteroidal anti-inflammatory medications (those known to inhibit platelet function at doses used to treat chronic inflammatory diseases). Patients can be rendered eligible by changing the treatment to COX II inhibitors.
18Chronic treatment with corticosteroids (dose of =10 mg/day methylprednisolone equivalent excluding inhaled steroids).
19Serious intercurrent infections (uncontrolled or requiring treatment).
20Current or recent (within the 28 days prior to randomisation) treatment with another investigational drug or participation in another investigational study.
21Patients with known allergy to Chinese hamster Ovary cell proteins or other recombinant human or humanized antibodies or to any excipients of bevacizumab formulation, platinum compounds or to any other component of the study drugs.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified