Clinical trial · Interventional
Doxorubicin, Cisplatin, 5-Fluorouracil in Patients With Advanced Adenocarcinoma of the Stomach or Esophagus
A Phase II Study of Doxorubicin, Cisplatin, and 5-Fluorouracil in Patients With Advanced Adenocarcinoma of the Stomach or Esophagus
NCT00165191CI-TRIAL-00002256completedPhase 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 information on the anti-tumor activity of the combination doxorubicin, cisplatin, and 5-fluorouracil when given to patients with advanced esophageal or gastric adenocarcinoma. We will also be collecting information about the side effects and safety of this combination.
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 |
|---|---|---|---|
| Adenocarcinoma of Esophagus | Esophageal Adenocarcinoma | ALIAS | 0.90 |
| Adenocarcinoma of GE Junction | — | UNRESOLVED | — |
| Adenocarcinoma of Stomach | Gastric Adenocarcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-fluorouracil | Drug | Fluorouracil | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To determine the activity of doxorubicin, cisplatin and continuous infusion of 5-fluorouracil in patients with measurable, locally unresectable or metastatic adenocarcinoma of the stomach, GE junction, or esophagus.
Secondary outcomes (2)
- measure
- Assess the safety of doxorubicin, cisplatin and 5-fluorouracil when given in combination to treat this patient population
- measure
- evaluate the survival of this patient population.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Measurable, locally unresectable or metastatic adenocarcinoma of the stomach, GE junction or esophagus * No more than one prior chemotherapy regimen * ECOG performance status of \< or equal to 2 * Life expectancy \> 12 weeks * ANC \> 1,500/mm3 * Hemoglobin \> 9.0 gm/dl * Platelets \> 100,000/mm3 * SGOT \< 3 x ULN * Total bilirubin \< 2.0 mg/dl * Creatinine \< 1.5 mg/dl Exclusion Criteria: * Prior cisplatin or doxorubicin as neoadjuvant or adjuvant therapy with in 1 year of study entry * Clinically apparent central nervous system metastases or carcinomatous meningitis * Myocardial infarction in the past 6 months * Major surgery in the past 2 weeks * Uncontrolled serious medical or psychiatric illness * Pregnant or lactating women * Concurrent malignancy of any site, except limited basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix * History or clinical evidence of congestive heart failure
References
Publications (0)
Data not yet available
No reference posted for this study.