A Phase 2 study of Tomudex & Iressa as second line chemotherapy in subjects with colorectal carcinoma

Exclusion Criteria

• - Known severe hypersensitivity to raltitrexed or any of the excipients of this product
• - known severe hypersensitivity to raltitrexed or any of the excipients of this product
• - active infection or uncontrolled diarrhoea
• - cerebral metastasis or meningeal carcinomatosis
• - any evidence of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded)
• - simultaneous antitumoral treatment
• - radiotherapy within 2 weeks before entry into the study
• - other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
• - any unresolved chronic toxicity greater than common toxicity criteria (CTC) grade 2 from previous anticancer therapy (except alopecia)
• - significant clinical disorder or laboratory finding (leukocyte count less than 3.0 x 109 /litre (L) or platelets less than 100 x 109 /L; serum total bilirubin more than 2.0 mg/dl; as judged by investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic, or renal disease); creatinine clearance ≥ 65ml/min (according to Cockcroft-Gault formula); alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2 times the upper limit of the reference range (ULRR) if no demonstrable liver metastases, or greater than 5 times the ULRR in the presence of liver metastases)
• - pregnancy or breast feeding (women of child-bearing potential)
• - concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or ST John’s Wort;
• - Treatment with a non- approved or investigational drug within 30 days before Day 1 of study treatment