Clinical trial · Interventional
Gemcitabine Plus Erlotinib Versus Erlotinib Plus Gemcitabine Plus Oxaliplatin, in Pancreatic Cancer
Phase II Study of Gemcitabine Plus Erlotinib Versus Erlotinib Plus Gemcitabine Plus Oxaliplatin, in Patients With Locally Advanced or Metastatic Pancreatic Cancer
NCT00564720CI-TRIAL-00009479terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to poor accrual of the study
Summary
Brief summary (as posted)
This randomized phase II trial will compare the efficacy and toxicity of Gemcitabine plus Erlotinib versus Gemcitabine plus Erlotinib plus Oxaliplatin in patients with 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Erlotinib | Drug | Erlotinib | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- GEM/TAR
- interventionNames
- Drug: Gemcitabine
- Drug: Erlotinib
- type
- EXPERIMENTAL
- label
- 2
- description
- GEM/OX/TAR
- interventionNames
- Drug: Gemcitabine
- Drug: Erlotinib
- Drug: Oxaliplatin
Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
- 1 year survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed pancreatic cancer. * Measurable disease. * Absence of ascites or obstructive jaundice. * ECOG Performance Status 0-2. * Adequate liver kidney and bone marrow function. * Written informed consent. Exclusion Criteria: * Chronic diarrheic syndrome. * Uncontrolled brain metastases after radiation. * Liver infiltration over 50%. * Peripheral neuropathy ≥ 2. * No second primary malignancy within the past 5 years, except non-melanomas skin cancer or in situ carcinoma of the cervix. * No active uncontrolled infection. * Active cardiac disease : unstable angina or onset of angina within last 3 months, myocardial infarction within 6 months, congestive heart failure \> class II, cardiac ventricular arrhythmias requiring anti-arrhythmic therapy. * Women who are pregnant or lactating.
References
Publications (0)
Data not yet available
No reference posted for this study.