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IRESSA Combined With Radiotherapy & Gemcitabine as First-Line Treatment in Locally Advanced Pancreatic Cancer
This study has been completed.
Sponsored by: AstraZeneca
Information provided by: AstraZeneca
ClinicalTrials.gov Identifier: NCT00234416
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer
Drug: Gefitinib
Drug: Gemcitabine
Phase I
Phase II

MedlinePlus related topics: Cancer Pancreatic Cancer
Drug Information available for: Gemcitabine hydrochloride Gemcitabine ZD1839
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: A Trial to Evaluate ZD1839 (IRESSA) in Combination With Radiotherapy & Gemcitabine as First-Line Treatment in Patients With Locally Advanced Pancreatic Cancer

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Incidence of DLT

Secondary Outcome Measures:
  • Overall objective tumour response (CR and PR) based on the Response Evaluation Criteria in Solid Tumours (RECIST), assessed by abdominal CT (abdominal scan)
  • Nature, incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

Estimated Enrollment: 45
Study Start Date: August 2002
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00234416

Locations
Spain
Research Site
Barcelona, Spain
Research Site
Valencia, Spain
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Spain Medical Director, MD AstraZeneca Spain
  More Information

Study ID Numbers: 1839IL/0100
Study First Received: October 5, 2005
Last Updated: March 3, 2008
ClinicalTrials.gov Identifier: NCT00234416  
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by AstraZeneca:
Pancreatic Cancer
EGF-R

Study placed in the following topic categories:
Digestive System Diseases
Digestive System Neoplasms
Pancreatic Neoplasms
Endocrine System Diseases
Pancreatic Diseases
Gastrointestinal Neoplasms
Endocrinopathy
Gemcitabine
Gefitinib
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on January 16, 2009