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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-05-C-0158 | |||
| NCI-P6503 |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bevacizumab | Drug | |||
| gemcitabine hydrochloride | Drug | |||
| adjuvant therapy | Procedure | |||
| anti-cytokine therapy | Procedure | |||
| antiangiogenesis therapy | Procedure | |||
| antibody therapy | Procedure | |||
| biological therapy | Procedure | |||
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
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| Name | Affiliation | Role |
|---|---|---|
| Richard E. Royal, MD, FACS | National Cancer Institute (NCI) | Principal Investigator |
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| chemotherapy |
| Procedure |
| conventional surgery | Procedure |
| growth factor antagonist therapy | Procedure |
| monoclonal antibody therapy | Procedure |
| surgery | Procedure |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D000093542 | Gemcitabine |
| D017024 | Chemotherapy, Adjuvant |
| D007116 | Immunization, Passive |
| D001691 | Biological Therapy |
| D004358 | Drug Therapy |
| D000911 | Antibodies, Monoclonal |
| D013514 | Surgical Procedures, Operative |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D007114 | Immunization |
| D007167 | Immunotherapy |
| D056747 | Immunomodulation |
| D007158 | Immunologic Techniques |
| D008919 | Investigative Techniques |
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