Adjuvant Xeloda Plus Eloxatin +/- Avastin After Radical Resection of Liver Metastasis of Colorectal Cancer

• Status: Terminated
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary aim of this study is to investigate whether the addition of the new anti-cancer drug bevacizumab (Avastin) to the combination of the chemotherapeutic agents capecitabine (Xeloda) and oxaliplatin (Eloxatin) reduces (slows down) the recurrence of metastatic disease after a radical resection of liver metastases in patients with colorectal cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dutch Colorectal Cancer Group
• Collaborators: Roche Pharma AG; Sanofi
• Treatments: Bevacizumab; Capecitabine; Oxaliplatin

Criteria

Inclusion Criteria:

• Signed written informed consent obtained prior to any study-specific procedures.

• Age ≥ 18 years.

• Liver metastases radically resected (R0 resection).

• Study medication started ≥4 and ≤ 8 weeks post liver surgery.

• Histologically confirmed liver metastasis of colorectal cancer after surgery.

• ECOG performance status 0 or 1.

• Adequate hematology: ANC ≥1.5 x 109/L, platelets ≥100 x 109/L, Hb ≥5.5 mmol/L, INR ≤ 1.5, APTT < 1.5 X UNL.

• Adequate biochemistry: total bilirubin ≤1.5 UNL, ASAT and ALAT ≤2.5 x UNL, alkaline phosphatase ≤2.5 x UNL, serum creatinine ≤1.5 UNL.

• Urine dipstick <2+ for protein.

Exclusion Criteria:

• Extrahepatic metastatic disease.

• Prior adjuvant chemotherapy given <6 months prior to detection of the liver metastases.

• Prior non colorectal malignancies.

• Bleeding diathesis or coagulation disorders or the need for full-dose anticoagulation.

• Major surgical procedure <4 weeks prior to start of study treatment.

• Females with a positive pregnancy test (within 14 days before treatment start) .

• Lactating women.

• Fertile women (<2 years after last menstruation) and women of childbearing potential not willing to use effective means of contraception.

• History of psychiatric disability judged by the investigator to be clinically significant, precluding informed consent or interfering with compliance for oral drug intake.

• Clinically significant (i.e. active) cardiovascular disease e.g. cerebrovascular accidents (≤6 months prior to randomization), myocardial infarction (≤1 year prior to randomization), uncontrolled hypertension while receiving chronic medication, unstable angina, New York Heart Association (NYHA) Grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication.

• Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medication.

• Known peripheral neuropathy, including oxaliplatin induced neuropathy > grade Absence of deep tendon reflexes as the sole neurological abnormality does not render the patient ineligible.

• Organ allografts requiring immunosuppressive therapy.

• Serious, non-healing wound, ulcer, or bone fracture.

• Current or recent (within 10 days prior to study treatment start) use of full-dose oral or parenteral anticoagulants or thrombolytic agent for therapeutic purposes.

• Chronic, 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.

• Chronic treatment with corticosteroids (dose of ≥ 10 mg/day methylprednisolone equivalent excluding inhaled steroids).

• Serious intercurrent infections (uncontrolled or requiring treatment).

• Current or recent (within the 28 days prior to randomization) treatment with another investigational drug or participation in another investigational study.

• Patients 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.