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

NCT00234416 | Completed Phase 1

• 1 other identifier: 1839IL/0100
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

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

Conditions

Pancreatic Cancer

Keywords

Pancreatic Cancer; EGF-R

Outcome Measures

Primary Outcomes (1)

• Incidence of DLT

Secondary Outcomes (2)

• 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)

Interventions

Gefitinib DRUG

Gemcitabine DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (2)

Research Site

Barcelona, Spain

Location

Research Site

Valencia, Spain

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gefitinib; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• AstraZeneca Spain Medical Director, MD

  AstraZeneca Spain

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 5, 2005
• First Posted: October 7, 2005
• Study Start: August 1, 2002
• Study Completion: March 1, 2005
• Last Updated: April 23, 2009

Record last verified: 2009-04

Locations

ES (2)