Status:
COMPLETED
IRESSA Combined With Radiotherapy & Gemcitabine as First-Line Treatment in Locally Advanced Pancreatic Cancer
Lead Sponsor:
AstraZeneca
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
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 standa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2002
Trial Type :
INTERVENTIONAL
End Date :
March 1 2005
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00234416
Start Date
August 1 2002
End Date
March 1 2005
Last Update
April 23 2009
Active Locations (2)
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1
Research Site
Barcelona, Spain
2
Research Site
Valencia, Spain