Clinical trial · Interventional
Docetaxel in Combination With Iressa in Previously Treated Patients With Pancreatic Cancer
A Phase II Study of Docetaxel in Combination With ZD 1839 (IRESSA) in Previously Treated Patients With Metastatic Pancreatic Cancer
NCT00137761CI-TRIAL-00002747completedPhase 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 purpose of this study is to find out what activity the combination of docetaxel and Iressa have against metastatic 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 |
|---|---|---|---|
| Metastatic Pancreatic Carcinoma | Pancreatic Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To determine the response rate of Iressa and docetaxel in patients with advanced pancreatic cancer following failure of gemcitabine-based therapy
- timeFrame
- 3 years
Secondary outcomes (1)
- measure
- To determine the safety, radiologic response rate, progression-free survival and overall survival of patients treated with Iressa and docetaxel
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Metastatic pancreatic carcinoma (excluding pancreatic endocrine tumors); histologic confirmation of either the primary or metastatic site. * ECOG performance status of \< 1 * \> 4 weeks since completion of previous chemotherapy * \> 4 weeks since participation in any investigational drug study * Peripheral neuropathy of grade \< 1 * Patients must have failed a gemcitabine-containing regimen administered in the metastatic, adjuvant, or locally advanced setting. * Absolute neutrophil count (ANC) \> 1,500/mm3 * Hemoglobin \> 9.0gm/dl * Platelets \> 100,000/mm3 * Total bilirubin \< 2.0mg/dl * AST and alkaline phosphatase \< 5 x upper limit of normal (ULN) * Albumin \> 2.5gm/dl * CA 19-9 \> 1.5 x ULN Exclusion Criteria: * Prior therapy with taxane or with epidermal growth factor receptor (EGFR) inhibitors * More than one prior chemotherapy treatment * Clinically significant cardiac disease * Major surgery within 4 weeks of the start of study treatment * Evidence of central nervous system (CNS) metastases or carcinomatous meningitis or history of uncontrolled seizures, central nervous system disorders. * Uncontrolled serious medical or psychiatric illness * Pregnant or breast-feeding women * Other active malignancy * Inability to swallow tablets or evidence of a gastrointestinal malabsorption syndrome * Known severe hypersensitivity to Iressa * Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, or St. John's wort. * History of severe hypersensitivity reaction to drugs formulated with polysorbate 80 * Any evidence of clinically active interstitial lung disease * Ascites requiring paracentesis
References
Publications (0)
Data not yet available
No reference posted for this study.