Clinical trial NCT00234416: IRESSA Combined With Radiotherapy & Gemcitabine as First-Line Treatment in Locally Advanced Pancreatic Cancer
Official title: A Trial to Evaluate ZD1839 (IRESSA) in Combination With Radiotherapy & Gemcitabine as First-Line Treatment in Patients With Locally Advanced Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Pancreatic Cancer
Keywords: Pancreatic Cancer
EGF-R
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-10-07
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Incidence of DLT
Secondary outcomes:
measure: Overall objective tumour response (CR and PR) based on the Response Evaluation Criteria in Solid Tumours (RECIST), assessed by abdominal CT (abdominal scan)
measure: Nature, incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
Study officials:
affiliation: AstraZeneca Spain
name: AstraZeneca Spain Medical Director, MD
role: STUDY_DIRECTOR
References: