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