A Trial to Evaluate ZD1839 (IRESSA) in Combination With Radiotherapy & Gemcitabine as First-Line Treatment in Patients With Locally Advanced Pancreatic Cancer
Inclusion Criteria:
- Histologically confirmed pancreatic cancer (aspiration biopsy by fine needle [PAAF]
by USE or biopsy guide by ECO-CT). It is mandatory the diagnostic by USE and will
recommend the aspiration biopsy with this technique
- Tumoural volume by TAC < 500 cc
- Aged 18 to 75 years inclusive
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) £ 1
- Life-expectancy of more than 12 weeks
- Women of child-bearing potential must be willing to practice reliable methods of
birth control to prevent pregnancy
Exclusion Criteria:
- Previous radiotherapy or chemotherapy for malignant disease
- Other co-existing malignancies or malignancies diagnosed within the last 5 years with
the exception of basal cell carcinoma or cervical cancer in situ
- In the opinion of the investigator, any evidence of severe or uncontrolled systemic
disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal
disease)
- Absolute neutrophil count (ANC) less than 1.5 x 109/litre (L), platelets less than
100 x 109/L or haemoglobin less than 9 mg/dL; Prothrombin time (PT) less than 50%;
Serum bilirubin greater than 2.5 times the upper limit of reference range (ULRR;
Creatinine clearance less than 45 mL/min; ALT or AST greater than 2.5 times the ULRR
- Active dermatoses (e.g. psoriasis, eczema)
- Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, or drugs with
known corneal toxicity
- Known, severe hypersensitivity to ZD1839 or any of the excipients of this product