Pancreatic Cancer
Conditions
Keywords
Pancreatic Cancer, EGF-R
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.
Interventions
DRUGGefitinib
DRUGGemcitabine
Sponsors
AstraZeneca
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of DLT | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Spain
Outcome results
None listed