A Phase 2 Study of Tomudex & Iressa as Second Line Chemotherapy in Subjects With Colorectal Carcinoma

Inclusion Criteria: * Male or female, aged 18 to 75 years, inclusive * histologically-confirmed metastatic colorectal carcinoma; measurable lesion according to the Response Evaluation Criteria in Solid Tumours (RECIST) * relapsed after treatment with a fluoropyrimidine-based chemotherapy * prior chemotherapeutic regimen for metastatic or locally advanced disease with an interval of at least 4 weeks between the last administration of chemotherapy an the first administration of study treatment * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 * life expectancy of at least 12 weeks 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