Study of Oxaliplatin, Capecitabine, and Bevacizumab to Treat Older Patients With Colorectal Cancer

Phase 2TerminatedNCT00120172

Geriatric Oncology Consortium40 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Colorectal Cancer Neoplasm Metastasis

Interventions

oxaliplatin, capecitabine, bevacizumabDRUG

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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;

Locations (5)

Unnamed facility

Mission Hills, California, United States

Unnamed facility

Washington D.C., District of Columbia, United States

Unnamed facility

Inverness, Florida, United States

Unnamed facility

New Port Richey, Florida, United States

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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