ABCSG C06 (98)/QUASAR 2 Details

Multicentre international study of capecitabine ± bevacizumab as adjuvant treatment of colon cancer

Start:
06/2007
End of randomizing:
15.10.2010
Sample size:
2.240 international,
200 national

Contact ABCSG-Trial office

E-mail: info@abcsg.at
Phone: +43 1 408 92 30
Fax: +43 1 409 09 90

Design

ABCSG-C06 Design
Click to enlarge

Primary objectives:

  • Disease free survival (3 year)

Secondary objectives:

  • Disease free survival for stage III patients (3 years)
  • Overall survival (5 year)
  • Side effect profiles
  • Translational science

Inclusion criteria

  1. Histologically proven stage III (stage T2, T3 or T4) and stage II (any one or more of the following – stage T4, lymphatic invasion, vascular invasion, peritoneal involvement, poor differentiation, obstruction and perforation of the primary tumour during the pre-operative period) colorectal cancer
  2. Patients must have undergone complete resection of the primary tumour without evidence of residual disease
  3. Patients must be randomised to start treatment a minimum of 28 days and maximum of 70 days* after surgery
  4. WHO Performance Status 0 or 1
  5. Male or female outpatients age 18 years
  6. Written informed consent given.
  7. Life expectancy of 5 years, in terms of non-cancer-related morbidity.

* Calculation of these dates is based on date of surgery being day 1.

Exclusion criteria

  1. Previous chemotherapy, immunotherapy or infra-diaphragmatic radiotherapy; or patients who are expected to require radiotherapy to these sites within the next 12 months, for any reason
  2. Received any investigational drug or agent/procedure, (i.e. participation in another treatment trial) within 4 weeks of randomisation
  3. Moderate or severe renal impairment [creatinine clearance <30ml/min]
  4. Any of the following laboratory values (tests must not have been carried out more than 2 weeks prior to randomisation):
    1. Absolute neutrophil count (ANC) <1.5 x 109/L
    2. Platelet count < 100 x 109/L
    3. Total bilirubin > 1.5 ULN
    4. ALT, AST > 2.5 x ULN
    5. Alkaline phosphatase > 2.5 x ULN (ULN = Upper Limit of Normal)
  5. Patients requiring chronic use of full dose oral or parenteral anticoagulants, high dose aspirin (>325mg/day), anti-platelet drugs or known bleeding diathesis. Low dose aspirin is allowed. Low dose clopidogrel (≤75mg) is allowed
  6. Proteinuria > 500 mg/24 hours
  7. Known coagulopathy
  8. Clinically significant cardiovascular disease [i.e. active; or <12 months since e.g. cerebrovascular accident, myocardial infarction, unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication; or uncontrolled hypertension]
  9. Concomitant treatment with sorivudine or its chemically related analogues such as brivudine
  10. Pregnant (positive pregnancy test within 7 days of starting treatment), or lactating women
  11. Sexually active patients of child bearing potential not using adequate contraception (male and female)**
  12. Previous malignancies other than adequately treated in situ carcinoma of the uterine cervix or basal or squamous cell carcinoma of the skin, unless there has been a disease-free interval of at least 10 years
  13. Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome or inability to take oral medication
  14. Chronic inflammatory bowel disease and/or active peptic ulcer, either of which have been active or required medication in the last 2 years
  15. History of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant precluding informed consent or interfering with compliance for oral drug intake
  16. Patients with known allergy to Chinese hamster ovary cell proteins or other recombinant human or humanized antibodies or to any excipients of bevacizumab formulation; or to any other study drugs

** Women of childbearing potential randomised to receive bevacizumab are required to have a serum pregnancy test at baseline (i.e. prior to starting treatment). Postmenopausal women must have been amenorrheic for at least 12 months to be considered of nonchildbearing potential.