Study of Oxaliplatin, Capecitabine, and Bevacizumab to Treat Older Patients With Colorectal Cancer
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Purpose
Currently there is no one standard of care for older patients with metastatic colorectal cancer. The study will examine the tumor response to capecitabine, oxaliplatin, plus bevacizumab. The study will also gather information on the usefulness and side effects of this treatment combination.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer Neoplasm Metastasis |
Drug: oxaliplatin, capecitabine, bevacizumab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
- 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
| Estimated Enrollment: | 40 |
| Study Start Date: | May 2005 |
| Study Completion Date: | June 2006 |
Colorectal cancer is primarily a disease of the elderly, with the median age in the United States of 70 years. Age greater than 65 years at presentation is not a contraindication to standard therapies; acceptable morbidity and mortality, as well as long term survival, are achieved in this patient population. However, studies evaluating combination therapy have generally involved younger patients with high performance status scores. Given the non-over-lapping safety profiles of the proposed study agents and the potential synergy, it would be of benefit to explore the combination of oxaliplatin, capecitabine, and bevacizumab in the treatment of older patients with colorectal cancer. Time to progression, overall response, duration of response, and toxicity profile will be evaluated. The feasibility of using a self-report geriatric assessment tool will also be assessed.
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| 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;
Contacts and Locations| 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 |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00120172 History of Changes |
| Other Study ID Numbers: | GOC-GI-010 |
| Study First Received: | July 8, 2005 |
| Last Updated: | November 15, 2007 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Geriatric Oncology Consortium:
|
colorectal metastatic elderly metastatic colorectal cancer |
Additional relevant MeSH terms:
|
Neoplasms Colorectal Neoplasms Neoplasm Metastasis Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Neoplastic Processes Pathologic Processes |
Oxaliplatin Capecitabine Bevacizumab Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |
ClinicalTrials.gov processed this record on October 16, 2012
