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| Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00074009 |
Purpose
RATIONALE: Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.
PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who have unresectable or metastatic gastric cancer or gastroesophageal junction adenocarcinoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastric Cancer |
Drug: bortezomib |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Multicenter, Open-Label, Two-Stage, Phase II Study Of PS-341 (LDP-341, NSC # 681239) In Patients With Unresectable Or Metastatic Gastric Adenocarcinoma |
| Study Start Date: | October 2003 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, nonrandomized, multicenter study.
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 15-33 patients will be accrued for this study within 5-12 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma
Measurable disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, Illinois | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637-1470 | |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| Queens Cancer Center of Queens Hospital | |
| Jamaica, New York, United States, 11432 | |
| United States, Wisconsin | |
| University of Wisconsin Comprehensive Cancer Center | |
| Madison, Wisconsin, United States, 53792-3236 | |
| Principal Investigator: | Manish A. Shah, MD | Memorial Sloan-Kettering Cancer Center |
| Principal Investigator: | Gary K. Schwartz, MD | Memorial Sloan-Kettering Cancer Center |
More Information
| Study ID Numbers: | CDR0000341565, MSKCC-03101, NCI-6003 |
| Study First Received: | December 10, 2003 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00074009 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent gastric cancer stage III gastric cancer stage IV gastric cancer adenocarcinoma of the stomach |
|
Digestive System Neoplasms Gastrointestinal Diseases Bortezomib Recurrence Carcinoma Protease Inhibitors Digestive System Diseases |
Stomach Diseases Stomach Neoplasms Gastrointestinal Neoplasms Stomach Cancer Adenocarcinoma Neoplasms, Glandular and Epithelial |
|
Neoplasms by Histologic Type Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gastrointestinal Diseases Bortezomib Enzyme Inhibitors Pharmacologic Actions Protease Inhibitors Carcinoma |
Neoplasms Neoplasms by Site Digestive System Diseases Stomach Diseases Therapeutic Uses Stomach Neoplasms Gastrointestinal Neoplasms Adenocarcinoma Neoplasms, Glandular and Epithelial |