Clinical trial · Interventional
Fluorouracil, Oxaliplatin, and Leucovorin in Treating Patients With Metastatic Stomach Cancer or Gastroesophageal Junction Cancer
Pharmacogenomically Selected Treatment for Gastric and Gastroesophageal Junction (GEJ) Tumors: A Phase II Study
NCT00514020CI-TRIAL-00008385completedPhase 2Results postedClinicalTrials.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)
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, oxaliplatin, and leucovorin, 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. PURPOSE: This phase II trial is studying how well giving fluorouracil together with oxaliplatin and leucovorin works in treating patients with metastatic stomach cancer or gastroesophageal junction 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 |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fluorouracil | Drug | Fluorouracil | ALIAS |
| gene expression analysis | Genetic | — | UNRESOLVED |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
| pharmacological study | Other | — | UNRESOLVED |
| polymorphism analysis | Genetic | — | UNRESOLVED |
| protein expression analysis | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- interventionNames
- Drug: fluorouracil
- Drug: leucovorin calcium
- Drug: oxaliplatin
- Genetic: gene expression analysis
- Genetic: polymorphism analysis
- Genetic: protein expression analysis
- Other: pharmacological study
Primary outcomes (1)
- measure
- Number of Patients With Each Response in "Good Risk" Genotype (Thymidylate Synthase Promoter Enhancer Region [TSER]*2/*2 or TSER*2/*3 Genotype [Low TS Expression])
- timeFrame
- every 8 weeks to progression
- description
- Per RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) \> 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) \> 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions. This is a one-time assessment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction * Metastatic disease * Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan * No known active brain metastases * Patients with treated brain metastases are eligible if stable off steroids for at least 30 days PATIENT CHARACTERISTICS: * ECOG performance status ≤ 2 (Karnofsky performance status ≥ 60%) * Life expectancy ≥ 3 months * WBC ≥ 3,000/μL * Absolute neutrophil count ≥ 1,500/μL * Platelets ≥ 100,000/μL * Total bilirubin ≤ 1.5 x upper limit of normal (ULN) * AST or ALT ≤ 2.5 x ULN (\< 5 x ULN if known liver metastases) * Creatinine clearance ≤ 1.5 x ULN * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 21 days after completion of study treatment * No history of allergic reactions to fluorouracil or oxaliplatin * No concurrent uncontrolled illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements PRIOR CONCURRENT THERAPY: * No prior therapy for metastatic disease * Prior neoadjuvant or adjuvant therapy is allowed if the disease-free interval has been longer than 6 months * No other concurrent chemotherapy * No concurrent combination anti-retroviral therapy for HIV-positive patients * No concurrent routine prophylaxis with filgrastim (G-CSF) * No other concurrent antineoplastic agents, including chemotherapy, radiation therapy, or biologic agents
References
Publications (0)
Data not yet available
No reference posted for this study.