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Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00253370 |
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as docetaxel 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 sorafenib together with docetaxel and cisplatin may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving sorafenib together with docetaxel and cisplatin works in treating patients with metastatic or locally advanced gastric or gastroesophageal junction cancer that cannot be removed by surgery.
Condition | Intervention | Phase |
---|---|---|
Gastric Cancer |
Drug: cisplatin Drug: docetaxel Drug: sorafenib tosylate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study to Evaluate Overall Response Rate of BAY 43-9006 (Sorafenib) Combined With Docetaxel And Cisplatin in the Treatment of Metastatic or Advanced Unresectable Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma |
Estimated Enrollment: | 38 |
Study Start Date: | October 2005 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is an open-label, multicenter study. Patients are stratified according to Siewert's tumor location (I vs II vs III) and extent of disease (locally advanced unresectable vs distant metastases).
Patients receive oral sorafenib twice daily on days 1-21. Patients also receive docetaxel IV over 1 hour and cisplatin IV over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 3 years.
PROJECTED ACCRUAL: A total of 38 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed gastric or gastroesophageal junction (GEJ) adenocarcinoma
PATIENT CHARACTERISTICS:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Immunologic
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Radiotherapy
Surgery
Other
No concurrent cytochrome P450 enzyme-inducing antiepileptic drugs including the following:
Study ID Numbers: | CDR0000450764, ECOG-E5203 |
Study First Received: | November 11, 2005 |
Last Updated: | October 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00253370 |
Health Authority: | United States: Food and Drug Administration |
recurrent gastric cancer stage IV gastric cancer stage III gastric cancer adenocarcinoma of the stomach |
Docetaxel Stomach Diseases Digestive System Diseases Digestive System Neoplasms Cisplatin Gastrointestinal Diseases |
Stomach Neoplasms Gastrointestinal Neoplasms Stomach cancer Adenocarcinoma Sorafenib Recurrence |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Radiation-Sensitizing Agents Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |