|
|
|
|
|
|
Sponsored by: |
Technische Universität München |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00601510 |
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.
Condition | Intervention | Phase |
Gastric Cancer |
Drug: capecitabine Drug: cisplatin Drug: imatinib mesylate |
Phase I |
MedlinePlus related topics: | Cancer Stomach Cancer |
Drug Information available for: | Cisplatin Imatinib Imatinib mesylate Capecitabine |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase I Study of Capecitabine, Cisplatin and Imatinib in Patients With Unresectable or Metastatic Gastric Cancer. |
Estimated Enrollment: | 28 |
Study Start Date: | November 2007 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed gastric cancer
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No concurrent warfarin or acetaminophen
Germany | |||||
Klinikum Rechts Der Isar - Technische Universitaet Muenchen | Recruiting | ||||
Munich, Germany, D-81675 | |||||
Contact: Contact Person 49-89-4140-4872 |
Technische Universität München |
Study Chair: | Matthias Ebert, MD | Technische Universität München |
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
Study ID Numbers: | CDR0000581134, KRDI-TUM-STI571, KRDI-TUM-GLIVEC-CSTI571BDE54, EU-20797, NOVARTIS-KRDI-TUM-STI571, EUDRACT-2006-005792-17 |
First Received: | January 25, 2008 |
Last Updated: | October 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00601510 |
Health Authority: | Unspecified |
|
|
|
|
|