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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00234416
• Other study ID #: 1839IL/0100
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 5, 2005
• Last updated: April 22, 2009
• Start date: August 2002
• Est. completion date: March 2005

Study information

• Verified date: April 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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 standard course (45 Grays [Gy]) of radiotherapy in patients with locally advanced, unresectable pancreatic cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Gefitinib

• Gemcitabine

Locations

Country	Name	City	State
Spain	Research Site	Barcelona
Spain	Research Site	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of DLT
Secondary	Overall objective tumour response (CR and PR) based on the Response Evaluation Criteria in Solid Tumours (RECIST), assessed by abdominal CT (abdominal scan)
Secondary	Nature, incidence and severity of adverse events (AEs) and serious adverse events (SAEs)