Gastric Cancer Clinical Trial
Official title:
A Phase I Study of Capecitabine, Cisplatin and Imatinib in Patients With Unresectable or Metastatic Gastric Cancer.
RATIONALE: Imatinib may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth. Drugs used in chemotherapy, such as capecitabine and cisplatin, work
in different ways to stop the growth of tumor cells, either by killing the cells or by
stopping them from dividing. Giving imatinib together with combination chemotherapy may kill
more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of imatinib when
given together with capecitabine and cisplatin in treating patients with unresectable or
metastatic stomach cancer.
OBJECTIVES:
Primary
- To determine the maximum tolerable dose and assess the safety and tolerability of
imatinib mesylate in combination with capecitabine and cisplatin in patients with
unresectable or metastatic gastric cancer.
Secondary
- To assess the preliminary antitumor activity of this regimen in these patients.
- To assess the response with regard to the expression and/or mutation of the tyrosine
kinase receptors PDGF-R and c-kit in gastric cancer.
OUTLINE: This is a dose-escalation study of imatinib mesylate.
Patients receive oral imatinib mesylate once daily on days -4 to 21 in course 1 and on days
1-21 in all subsequent courses, oral capecitabine twice daily on days 1-14, and cisplatin IV
on day 1. Courses repeat every 3 weeks* for 12 months in the absence of disease progression
or unacceptable toxicity.
NOTE: *First course is 25 days.
After completion of study therapy, patients are followed every 3 weeks.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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