Clinical trial · Interventional
Gemcitabine and Oxaliplatin in Treating Patients With Metastatic Pancreatic Cancer
Phase II Randomisee Dans Les Adenocarcinomes Metastatiques Du Pancreas: Gemox Et Gemox Simplifie. [GEMOX]
- 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)
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether giving both of these drugs on the same day is more effective than giving them on different days. PURPOSE: This randomized phase III trial is studying two different schedules of gemcitabine and oxaliplatin to compare how well they work in treating patients with 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 |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Objective response rate
Secondary outcomes (2)
- measure
- Clinical benefits and tolerability
- measure
- Progression-free and overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the pancreas * Metastatic disease * Measurable disease (primary tumor or metastasis) * At least 1 cm in diameter by spiral CT scan * No ampulla of Vater carcinoma or biliary adenocarcinoma * No known brain metastases PATIENT CHARACTERISTICS: * ECOG performance status (PS) 0-2 or Karnofsky PS 60-100% * Life expectancy more than 12 weeks * Absolute neutrophil count \> 1,500/mm\^3 * Platelet count \> 100,000/mm\^3 * Alkaline phosphatase \< 5 times normal * Bilirubin \< 1.5 times normal * Creatinine \< 1.5 times normal * No pre-existing neuropathy * No unstable or uncontrolled pain * Not pregnant or nursing * Fertile patients must use effective contraception * No serious cardiovascular disease * No serious respiratory disease * No uncontrolled or persistent hypercalcemia * No psychological, familial, social, or geographical condition that would preclude study treatment * No other active malignancy PRIOR CONCURRENT THERAPY: * No prior chemotherapy or radiotherapy * No concurrent corticosteroids
References
Publications (0)
Data not yet available