Clinical trial · Interventional
IRESSA Combined With Radiotherapy & Gemcitabine as First-Line Treatment in Locally Advanced Pancreatic Cancer
A Trial to Evaluate ZD1839 (IRESSA) in Combination With Radiotherapy & Gemcitabine as First-Line Treatment in Patients With Locally Advanced Pancreatic Cancer
NCT00234416CI-TRIAL-00002238completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gefitinib | Drug | Gefitinib | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Incidence of DLT
Secondary outcomes (2)
- 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)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.