Clinical trial · Interventional
The Efficacy and Safety of Gemcitabine in Combination With Docetaxel to Treat Pancreatic or Biliary Cancer
National Trial Phase II to Study the Combination of Gemcitabine and Docetaxel in Patients With Locally Advanced or Metastatic Pancreatic or Biliary Adenocarcinoma That Cannot be Removed by Surgery
NCT00268840CI-TRIAL-00005133completedPhase 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 assess the efficacy of combination therapy with gemcitabine and docetaxelin in patients with locally advanced or metastatic pancreatic or biliary adenocarcinoma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Tract Neoplasms | — | UNRESOLVED | — |
| Pancreatic Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- unique
- description
- Taxotère - Gemzar
- interventionNames
- Drug: Docetaxel
- Drug: Gemcitabine
Primary outcomes (1)
- measure
- Overall response rate
Secondary outcomes (4)
- measure
- Clinical benefit
- measure
- Progression-free survival
- measure
- Overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Patients aged 18 years or older * Patients must sign informed consent prior to study entry * Patients has Karnofsky performance status of more than 50% * No prior chemotherapy * Histologically or cytologically confirmed adenocarcinoma of the pancreas, locally advanced or metastatic disease or biliary cancer * No previous radiotherapy for locally advanced or metastases. * Hematopoietic: WBC \> 3000/mm2, Absolute neutrophile count \> 1500/mm2, Hemoglobin \> 9g/dl, Platelet count \> 100 000/mm2 Exclusion Criteria: * No intracerebral or meningeal metastases * Pregnant * Fertile patient must use effective contraception * No other serious medical condition or illness that would preclude study participation * Hepatic: Bilirubin greater than upper limit of normal(ULN) SGOT and SGPT \> 3.5 times upper limit of normal(ULN) alkaline phosphatase \> 6 times upper limit of normal(ULN) * More than 30 days since prior investigational therapy
References
Publications (0)
Data not yet available
No reference posted for this study.