Colorectal Cancer, Neoplasm Metastasis
Conditions
Keywords
colorectal, metastatic, elderly, metastatic colorectal cancer
Brief summary
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.
Detailed description
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.
Interventions
DRUGoxaliplatin, capecitabine, bevacizumab
Sponsors
Sanofi
Geriatric Oncology Consortium
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United States
Outcome results
None listed