Gastric Cancer Clinical Trial
Official title:
A Phase I/II Study of Taxotere, Oxaliplatin, and 5- Fluorouracil
RATIONALE: Drugs used in chemotherapy, such as docetaxel, oxaliplatin, and fluorouracil, 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 I/II trial is studying the side effects and best dose of docetaxel when
given with oxaliplatin and fluorouracil and to see how well they work in treating patients
with metastatic or unresectable stomach cancer, gastroesophageal junction cancer, or other
solid tumor.
OBJECTIVES:
Primary
- To establish the maximum tolerated dose of docetaxel when administered with oxaliplatin
and fluorouracil in patients with metastatic or unresectable solid tumors. (Phase I)
- To determine the response rate in patients with metastatic or unresectable
adenocarcinoma of the stomach or gastroesophageal junction treated with this regimen.
(Phase II)
Secondary
- To determine the dose limiting toxicity of this regimen in these patients.
- To evaluate the frequency of CYP3A4, CYP3A5, and MDR polymorphisms and their impact on
toxicity of docetaxel.
- To evaluate the frequency of XRCC1 and ERCC2 polymorphisms and their impact on the
toxicity of oxaliplatin.
- To evaluate the frequency of DPD and TSER polymorphisms and their impact on the toxicity
of fluorouracil.
- To characterize the toxicity profile of this regimen in these patients.
OUTLINE: This is a dose-escalation study of docetaxel.
Patients receive docetaxel IV over 1 hour and oxaliplatin IV over 2 hours on day 1 and
fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 14 days
for at least 2 courses in the absence of disease progression, symptomatic tumor progression,
or unacceptable toxicity.
Patients undergo blood sample collection periodically for pharmacokinetic and pharmacogenomic
correlative studies. Plasma concentrations of docetaxel are analyzed by reverse-phase high
performance liquid chromatography and tandem mass spectrometry. Polymorphisms in CYP3A4/5,
MDR, and other genes are analyzed by PCR.
After completion of study therapy, patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 73 patients (30 for phase I and 43 for phase II) will be
accrued for this study.
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