Study to Assess Safety and Tolerability of G17DT in Patients With Colorectal Adenocarcinoma. (CC1A&B)

Inclusion Criteria:

• Histologically verified adenocarcinoma of the colon or rectum
• Recurrent/ metastatic disease not amenable to curative surgery and/or radiotherapy
• measurable/ evaluable lesions
• Life expectancy > 3 months
• Karnofsky index > 50% or WHO performance rating of 0-2

• Biochemical markers:

  • renal function < 25% above upper limit of normal range (creatinine, 140 imol/1 unless malignant involvement proven)
  • liver function < 25% above upper limit of normal range (bilirubin ~25 mcmol/1 unless malignant involvement proven)

• Haematological status:

  • haemoglobin, 11 g/ dl
  • WBC, 4 X 109/1
  • platelets, 100 x 109/l
• Written consent

Exclusion Criteria:

• Other concomitant malignant disease except treated basal cell carcinoma of the skin or cancer of the uterine cervix stage 0-1
• H 2 receptor antagonist or proton pump inhibitor therapy
• Previous gastric surgery (including vagotomy)
• Active uncontrolled infection
• Autoimmune disorders
• Anticancer treatment within the last three months unless progression of the disease occurred in the interim
• Women of child-bearing age
• Patient is a poor medical risk because of non-malignant systemic disease
• Previous radiotherapy to all measurable or evaluable lesions.