A Phase 2 interventional study of fluorouracil and leucovorin calcium in Gastric Cancer, sponsored by Vanderbilt-Ingram Cancer Center. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-11-01.
Sponsored by Vanderbilt-Ingram Cancer Center · Phase 2, Interventional, and Treatment
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.
OBJECTIVES:
Primary
OUTLINE: This is a multicenter study.
Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
Available tumor tissue samples are assessed for expression of TS at the mRNA and protein levels. The results are correlated with germline and tumor TSER genotypes as well as response to the study treatment regimen. Polymorphisms in other genes associated with treatment outcome or toxicity are also assessed.
After completion of study treatment, patients are followed periodically for 4 years.
2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.
This study's enrollment of 33 is below the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Vanderbilt-Ingram Cancer Center is the lead sponsor of 220 studies on the registry; 32 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 18 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Patients must have histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction
No known active brain metastases
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No prior therapy for metastatic disease
Drug: fluorouracil · Drug: leucovorin calcium · Drug: oxaliplatin · Genetic: gene expression analysis · Genetic: polymorphism analysis · Genetic: protein expression analysis · Other: pharmacological study
Given through a vein over 5 minutes and then continuously over 46 hours on days 1 and 15.
through a vein over 2 hours on days 1 and 15.
500 ml D5W through a vein over 2 hours on days 1 and 15.
Blood collection
Blood collection
Blood collection
Blood collection
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])
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.
Time frame: every 8 weeks to progression
This study was conducted from August 2007 to March 2011.
| Milestone | 5-FU, Leucovorin, Oxaliplatin |
|---|---|
| Started | 33 |
| Completed | 5 |
| Not completed | 28 |
| Withdrew: Adverse event | 6 |
| Withdrew: Withdrawal by subject | 3 |
| Withdrew: Physician decision | 1 |
| Withdrew: Disease progression | 9 |
| Withdrew: Other complicating disease | 2 |
| Withdrew: Patient went to radiation treatment | 1 |
| Withdrew: Patients moved to the "no tx" group | 6 |
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.
| participants | Oxaliplatin + Leucovorin + 5-Fluorouracil |
|---|---|
| Complete Response | 0 |
| Partial Response | 9 |
| Progressive Disease | 1 |
| Stable Disease | 14 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Oxaliplatin + Leucovorin + 5-Fluorouracil | — | 14/24 (58.3%) | 24/24 (100%) |
| Event | Oxaliplatin + Leucovorin + 5-Fluorouracil |
|---|---|
| pain-abdomen NOSGastrointestinal disorders | 6/24 |
| nauseaGastrointestinal disorders | 4/24 |
| constipationGastrointestinal disorders | 3/24 |
| dysphagiaGastrointestinal disorders | 3/24 |
| vomitingGastrointestinal disorders | 3/24 |
| death not associated with CTCAE-disease progression NOSGeneral disorders | 2/24 |
| supraventricular and nodal arrhythmia-atrial fibrillationCardiac disorders | 2/24 |
| distension/bloating, abdominalGastrointestinal disorders | 1/24 |
| fever (in the absence of neutropenia, where neutropenia is defined as ANC < 1.0 x 10e9/L)General disorders | 1/24 |
| obstruction, GU-ureterRenal and urinary disorders | 1/24 |
| Event | Oxaliplatin + Leucovorin + 5-Fluorouracil |
|---|---|
| hemoglobinInvestigations | 22/24 |
| albumin, serum-lowMetabolism and nutrition disorders | 17/24 |
| nauseaGastrointestinal disorders | 15/24 |
| leukocytes (total WBC)Blood and lymphatic system disorders | 14/24 |
| neuropathy - sensoryNervous system disorders | 14/24 |
| plateletsBlood and lymphatic system disorders | 14/24 |
| fatigueGeneral disorders | 12/24 |
| Neutrophils/granulocytes (ANC/AGC)Blood and lymphatic system disorders | 12/24 |
| ALT/SGPT (serum glutamine pyruvic transminase)Investigations | 11/24 |
| AST, SGOT (serum glutamine oxaloacetic transminase)Investigations | 11/24 |
| Age, Categorical(Participants) | Oxaliplatin + Leucovorin + 5-Fluorouracil |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 20 |
| >=65 years | 13 |
| Age Continuous(years) | Oxaliplatin + Leucovorin + 5-Fluorouracil |
|---|---|
| Mean | 58 ± 1 |
| Sex: Female, Male(Participants) | Oxaliplatin + Leucovorin + 5-Fluorouracil |
|---|---|
| Female | 13 |
| Male | 20 |
| Region of Enrollment(participants) | Oxaliplatin + Leucovorin + 5-Fluorouracil |
|---|---|
| United States | 33 |
This study is completed, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.
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Vanderbilt-Ingram Cancer Center