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Sponsors and Collaborators: |
Duke University National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00416494 |
RATIONALE: Drugs used in chemotherapy, such as capecitabine, and oxaliplatin, 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 find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving capecitabine and oxaliplatin together with bevacizumab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving oxaliplatin and capecitabine together with bevacizumab works in treating patients with metastatic or recurrent colorectal cancer.
Condition | Intervention | Phase |
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Colorectal Cancer |
Drug: bevacizumab Drug: capecitabine Drug: oxaliplatin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Study of Oxaliplatin, Capecitabine and Bevacizumab in the Treatment of Metastatic Colorectal Cancer |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive oral capecitabine twice daily on days 1-5 and 8-12, oxaliplatin IV over 2 hours on day 1, and bevacizumab IV over 1-1½ hours on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 50 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 documented adenocarcinoma of the colon or rectum
PATIENT CHARACTERISTICS:
No unstable or poorly controlled hypertension (> 150/100 mm Hg)
PRIOR CONCURRENT THERAPY:
Study ID Numbers: | CDR0000449971, DUMC-4951-05-7R2, GENENTECH-DUMC-4951-05-7R2, SANOFI-DUMC-4951-05-7R2, ROCHE-DUMC-4951-05-7R2 |
Study First Received: | December 27, 2006 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00416494 |
Health Authority: | United States: Food and Drug Administration |
adenocarcinoma of the colon recurrent colon cancer stage IV colon cancer |
adenocarcinoma of the rectum recurrent rectal cancer stage IV rectal cancer |
Capecitabine Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Colonic Diseases Bevacizumab Intestinal Diseases Rectal Diseases Recurrence |
Intestinal Neoplasms Rectal neoplasm Oxaliplatin Digestive System Diseases Gastrointestinal Neoplasms Adenocarcinoma Rectal cancer Colorectal Neoplasms |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Angiogenesis Inhibitors |
Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors |