|
|
|
|
|
|
Sponsored by: |
Roswell Park Cancer Institute |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00107315 |
RATIONALE: 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 and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of colorectal cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with capecitabine may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with capecitabine works as first-line therapy in treating older patients with metastatic colorectal cancer.
Condition | Intervention | Phase |
Colorectal Cancer |
Drug: bevacizumab Drug: capecitabine |
Phase II |
MedlinePlus related topics: | Cancer Colorectal Cancer |
ChemIDplus related topics: | Capecitabine Bevacizumab |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of Capecitabine and Bevacizumab in Elderly Patients With Metastatic Colorectal Cancer |
Estimated Enrollment: | 40 |
Study Start Date: | March 2004 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label study.
Patients receive bevacizumab IV over 30-90 minutes on day 1 and oral capecitabine twice daily on days 1-7. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 13-16 months.
Ages Eligible for Study: | 70 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically* or cytologically* confirmed colorectal cancer
Measurable disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
No proteinuria OR clinically significant renal function impairment
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, New York | |||||
Roswell Park Cancer Institute | |||||
Buffalo, New York, United States, 14263-0001 |
Roswell Park Cancer Institute |
Principal Investigator: | Marwan Fakih, MD | Roswell Park Cancer Institute |
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
Study ID Numbers: | CDR0000420933, RPCI-I-22204, GENENTECH-RPCI-I-22204 |
First Received: | April 5, 2005 |
Last Updated: | September 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00107315 |
Health Authority: | United States: Federal Government |
|
|
|
|
|