IRESSA Combined With Radiotherapy & Gemcitabine as First-Line Treatment in Locally Advanced Pancreatic Cancer
Phase 1
Completed
- Conditions
- Pancreatic Cancer
- Registration Number
- NCT00234416
- Lead Sponsor
- AstraZeneca
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Incidence of DLT
- Secondary Outcome Measures
Name Time Method 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)
Trial Locations
- Locations (1)
Research Site
🇪🇸Valencia, Spain