IRESSA Combined With Radiotherapy & Gemcitabine as First-Line Treatment in Locally Advanced Pancreatic Cancer

AstraZeneca

Status and phase

Completed

Phase 2

Phase 1

Conditions

Pancreatic Cancer

Treatments

Drug: Gemcitabine

Drug: Gefitinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT00234416

1839IL/0100

Details and patient eligibility

About

The primary objective of the trial is to identify the dose of gemcitabine given as a 2-hour intravenous (iv) infusion that can be administered in combination with ZD1839 250 mg once daily and a standard course (45 Grays [Gy]) of radiotherapy in patients with locally advanced, unresectable pancreatic cancer.

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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