Phase 2
N=33
Fluorouracil, Oxaliplatin, and Leucovorin in Treating Patients With Metastatic Stomach Cancer or Gastroesophageal Junction Cancer
Gastric Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00514020 ↗Enrolled (actual)
33
Serious AEs
58.3%
Results posted
Oct 2012
Primary outcome: Primary: 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]) — 0; 9; 1; 14 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- fluorouracil (Drug); leucovorin calcium (Drug); oxaliplatin (Drug); gene expression analysis (Genetic); polymorphism analysis (Genetic); protein expression analysis (Genetic); pharmacological study (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanderbilt-Ingram Cancer Center
- Primary completion
- Jan 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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]) |
0; 9; 1; 14 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00514020). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.