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A Trial to Evaluate ZD1839 (IRESSA) in Combination With Radiotherapy & Gemcitabine as First-Line Treatment in Patients With Locally Advanced Pancreatic Cancer


Phase 1/Phase 2
18 Years
75 Years
Not Enrolling
Both
Pancreatic Cancer

Thank you

Trial Information

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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of DLT

Principal Investigator

AstraZeneca Spain Medical Director, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca Spain

Authority:

Spain: Spanish Agency of Medicines

Study ID:

1839IL/0100

NCT ID:

NCT00234416

Start Date:

August 2002

Completion Date:

March 2005

Related Keywords:

  • Pancreatic Cancer
  • Pancreatic Cancer
  • EGF-R
  • Pancreatic Neoplasms

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