Clinical trial · Interventional
Vinorelbine in Unresectable or Metastatic Esophageal and Gastric Adenocarcinoma
A Phase II Study of Vinorelbine in Unresectable or Metastatic Esophageal and Gastric Adenocarcinoma
NCT00215462CI-TRIAL-00002253completedPhase 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 collect anti-tumor activity of vinorelbine when given to patients with esophageal or gastric tumors. We will also collect information on the toxicities of vinorelbine in these patients.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Stomach Cancer | Malignant Gastric Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vinorelbine | Drug | Vinorelbine | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To assess the anti-tumor activity of vinorelbine when administered to patients with locally advanced or metastatic esophageal or gastric adenocarcinoma.
Secondary outcomes (1)
- measure
- To evaluate the toxicities of vinorelbine in this patient population.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Locally unresectable or metastatic esophageal adenocarcinoma. Locally unresectable or metastatic gastric adenocarcinoma. Only patients with measurable tumors are eligible. * No more than one prior chemotherapy regimen * ECOG performance status of 0-1 * Life expectancy of \> 12 weeks * Greater than or equal to 1,200 calorie/day intake * ANC \> 1,500/mm3 * AST \< 3 x ULN * Total bilirubin \< 2.0 ng/dl * Platelets \> 100,000/mm3 * Serum creatinine \< 2.0 mg/dl Exclusion Criteria: * Prior therapy with vinca alkaloids * Chemotherapy within the past three weeks * Clinically apparent central nervous system metastases or carcinomatous meningitis * Peripheral neuropathy \> 1
References
Publications (0)
Data not yet available
No reference posted for this study.