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Sponsors and Collaborators: |
California Cancer Consortium National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00103103 |
RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Drugs used in chemotherapy, such as fluorouracil and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with fluorouracil and leucovorin may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving bortezomib together with fluorouracil and leucovorin works in treating patients with metastatic or unresectable stomach cancer.
Condition | Intervention | Phase |
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Gastric Cancer |
Drug: bortezomib Drug: fluorouracil Drug: leucovorin calcium |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Combination Trial of PS-341 and 5-FU/LV in Gastric and/or GE Junction Adenocarcinoma |
Study Start Date: | March 2005 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a non-randomized, multicenter study.
Patients receive bortezomib IV over 3-5 seconds on days 1, 8, and 15. One hour after completion of bortezomib, patients receive leucovorin calcium IV and fluorouracil IV followed by fluorouracil IV continuously over 46 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for survival.
PROJECTED ACCRUAL: A total of 12-37 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:
Diagnosis of gastric or gastroesophageal junction adenocarcinoma
Progressive disease after receiving 1 prior chemotherapy regimen for metastatic disease comprising 1 of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
No significant conduction abnormality by EKG, including either of the following:
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, California | |
City of Hope Comprehensive Cancer Center | |
Duarte, California, United States, 91010-3000 | |
City of Hope Medical Group | |
Pasadena, California, United States, 91105 | |
University of California Davis Cancer Center | |
Sacramento, California, United States, 95817 | |
USC/Norris Comprehensive Cancer Center and Hospital | |
Los Angeles, California, United States, 90089-9181 | |
United States, Pennsylvania | |
Hillman Cancer Center at University of Pittsburgh Cancer Institute | |
Pittsburgh, Pennsylvania, United States, 15232 |
Study Chair: | Heinz-Josef Lenz, MD | USC/Norris Comprehensive Cancer Center |
Study ID Numbers: | CDR0000410827, CCC-PHII-43, NCI-5991, LAC-USC-3G036 |
Study First Received: | February 7, 2005 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00103103 History of Changes |
Health Authority: | United States: Federal Government |
recurrent gastric cancer stage IV gastric cancer adenocarcinoma of the stomach |
Antimetabolites Vitamin B Complex Digestive System Neoplasms Immunologic Factors Gastrointestinal Diseases Bortezomib Leucovorin Trace Elements Folinic Acid Immunosuppressive Agents Recurrence |
Protease Inhibitors Calcium, Dietary Digestive System Diseases Stomach Diseases Vitamins Stomach Neoplasms Fluorouracil Gastrointestinal Neoplasms Micronutrients Stomach Cancer Adenocarcinoma |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Gastrointestinal Diseases Antineoplastic Agents Physiological Effects of Drugs Leucovorin Stomach Diseases Neoplasms by Site Stomach Neoplasms Therapeutic Uses Vitamins |
Micronutrients Digestive System Neoplasms Vitamin B Complex Growth Substances Bortezomib Enzyme Inhibitors Immunosuppressive Agents Pharmacologic Actions Protease Inhibitors Neoplasms Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms |