Clinical trial · Interventional
Oxaliplatin, Gemcitabine, and Erlotinib Study in Patients With Advanced Chemo-naïve Pancreatic Cancer
NCT00636883CI-TRIAL-00013534GEMOX-TterminatedPhase 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): slow accrual rate
Summary
Brief summary (as posted)
The purpose of this study is to determine if the combination of Gemcitabine, Oxaliplatin and Erlotinib in the treatment of patients with pancreatic cancer will provide increased clinical benefits and improvement in their quality of life.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Response rate (partial and complete response, stable disease, and progressive disease)
- timeFrame
- Tumor response will be assessed following the induction therapy and after cycle 4,8 and at the end of the treatment.
Secondary outcomes (1)
- measure
- Overall survival
- timeFrame
- UNMEASURABLE
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patient's age between 18 and 75 years. 2. Presence of microscopic diagnosis of pancreatic cancer. 3. The disease is Locally advanced deemed by the surgeon to be unresectable, or metastatic disease. 4. Karnofsky Performance status \>50%. 5. Prior radiotherapy for local diseases is allowed provided disease progression had been documented, and treatment completed at least 4 weeks before random assignment 6. Prior chemotherapy is not permitted, except for fluorouracil given concurrently as a radiosensitizer. 7. Patients must have normal organ function evidenced by * Cr \<1.5 ULN * ANC \>1000 * platelets\> 100,000 * total bilirubin \<1.5ULN. 8. Pain should be controlled for at least two weeks without an increase in the narcotic consumption. 9. Biliary obstruction should be controlled for at least two weeks evident by stable or improving liver function tests especially total bilirubin. 10. Patient has signed a Patient Informed Consent Form. 11. For all females of childbearing potential, a negative pregnancy test must be obtained within 72 hours before starting therapy. Exclusion Criteria: 1. Contraindication to chemotherapy. 2. Evidence of uncontrolled CNS disease (patients with controlled CNS disease for 4 weeks using the same imaging method and for whom are off steroid will be eligible) 3. Uncontrolled Nausea and Vomiting 4. Diagnosis of other malignancy in the last 5 years excluding non-melanoma skin cancer and in -situ cervical cancer. 5. Subjects unlikely to comply with protocol, e.g. uncooperative attitude, inability to return for follow- up visits and unlikelihood of completing the study. 6. Any known history of hypersensitivity to the study drugs. 7. Pregnant or lactating women. 8. Participation in a clinical trial with any investigational drug used with curative intent and within 30 days prior to study entry 9. Peripheral sensitive neuropathy with functional impairment prior to study entry.
References
Publications (0)
Data not yet available
No reference posted for this study.