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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00253526 |
RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells an help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of pancreatic cancer by blocking blood flow to the tumor. Giving gemcitabine hydrochloride together with bevacizumab after surgery may kill any remaining tumor cells.
PURPOSE: This phase II trial is studying gemcitabine hydrochloride and bevacizumab to see how well they work compared to gemcitabine hydrochloride alone in treating patients who are undergoing surgery for pancreatic cancer.
Condition | Intervention | Phase |
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Adenocarcinoma of the Pancreas Recurrent Pancreatic Cancer Stage I Pancreatic Cancer Stage II Pancreatic Cancer Stage III Pancreatic Cancer |
Drug: bevacizumab Drug: gemcitabine hydrochloride Procedure: adjuvant therapy Procedure: anti-cytokine therapy Procedure: antiangiogenesis therapy Procedure: antibody therapy Procedure: biological therapy Procedure: chemotherapy Procedure: conventional surgery Procedure: growth factor antagonist therapy Procedure: monoclonal antibody therapy Procedure: surgery |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase II Randomized Study of Surgical Resection and Adjuvant Gemcitabine Hydrochloride With Versus Without Bevacizumab in Patients With Adenocarcinoma of the Pancreas |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, controlled study.
All patients undergo surgical resection for the pancreatic tumor. Within 4-8 weeks after surgery, patients are stratified according to projected 2-year survival (≤ 5% vs > 5% and ≤ 33% vs > 33%). Patients are randomized to 1 of 2 treatment arms.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 130 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:
PATIENT CHARACTERISTICS:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Study ID Numbers: | CDR0000448825, NCI-05-C-0158, NCI-P6503 |
Study First Received: | November 11, 2005 |
Last Updated: | December 4, 2006 |
ClinicalTrials.gov Identifier: | NCT00253526 |
Health Authority: | United States: Federal Government |
Digestive System Neoplasms Pancreatic Neoplasms Endocrine System Diseases Bevacizumab Pancrelipase Recurrence Carcinoma Antibodies, Monoclonal Antibodies |
Digestive System Diseases Gastrointestinal Neoplasms Pancreatic Diseases Endocrinopathy Adenocarcinoma Gemcitabine Immunoglobulins Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms |
Antimetabolites Anti-Infective Agents Neoplasms by Histologic Type Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors |
Angiogenesis Inhibitors Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents |