Study of Oxaliplatin, Capecitabine, and Bevacizumab to Treat Older Patients With Colorectal Cancer
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ClinicalTrials.gov Identifier: NCT00120172 |
Recruitment Status :
Terminated
(positive results from a larger study with same regimen was released.)
First Posted : July 15, 2005
Last Update Posted : November 16, 2007
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Colorectal Cancer Neoplasm Metastasis | Drug: oxaliplatin, capecitabine, bevacizumab | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase II Study of Oxaliplatin, Capecitabine, and Bevacizumab in the Treatment of Elderly Patients With Metastatic Colorectal Cancer |
Study Start Date : | May 2005 |
Actual Study Completion Date : | June 2006 |

- To evaluate the efficacy (measured by time to progression) of oxaliplatin, capecitabine, and bevacizumab as first-line therapy in elderly patients with metastatic colorectal cancer.
- Overall response
- Duration of response
- Safety and tolerability (NCI CTCAE v3.0, discontinuations, dose intensity)
- Vulnerable Elders Survey (VES-13) and Geriatric Depression Scale (GDS) scores

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Ages Eligible for Study: | 65 Years and older (Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age 65 years and above;
- Histologically or cytologically documented adenocarcinoma of the colon or rectum;
- Metastatic disease;
- Measurable disease or assessable but nonmeasurable disease allowed;
- ECOG 0-1
- No prior oxaliplatin or bevacizumab.
- No prior chemotherapy for metastatic disease. Prior adjuvant chemotherapy allowed;
- No prior fluoropyrimidine therapy (unless give in an adjuvant setting and completed at least 4 months earlier);
- No bleeding diathesis or coagulopathy
- Adequate renal and hepatic functions as per protocol;
- Signed informed consent
Exclusion Criteria:
- Clinically significant cardiovascular or peripheral vascular disease;
- Concurrent chronic aspirin, nonsteroidal anti-inflammatory drugs, warfarin, or therapeutic heparin;
- Serious non-healing wound, ulcer, or bone fracture;

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00120172
United States, California | |
Mission Hills, California, United States, 91345 | |
United States, District of Columbia | |
Washington, District of Columbia, United States, 20007 | |
United States, Florida | |
Inverness, Florida, United States, 34452 | |
New Port Richey, Florida, United States, 34652 | |
United States, Idaho | |
Coeur D'Alene, Idaho, United States, 83814 |
Study Chair: | Stuart Lichtman, MD | Geriatric Oncology Consortium |
ClinicalTrials.gov Identifier: | NCT00120172 |
Other Study ID Numbers: |
GOC-GI-010 |
First Posted: | July 15, 2005 Key Record Dates |
Last Update Posted: | November 16, 2007 |
Last Verified: | November 2007 |
colorectal metastatic elderly metastatic colorectal cancer |
Colorectal Neoplasms Neoplasm Metastasis Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Neoplastic Processes Pathologic Processes |
Bevacizumab Capecitabine Oxaliplatin Antineoplastic Agents, Immunological Antineoplastic Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action |