Clinical trial NCT00120172: Study of Oxaliplatin, Capecitabine, and Bevacizumab to Treat Older Patients With Colorectal Cancer
Official title: A Phase II Study of Oxaliplatin, Capecitabine, and Bevacizumab in the Treatment of Elderly Patients With Metastatic Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Colorectal Cancer
Neoplasm Metastasis
Keywords: colorectal
metastatic
elderly
metastatic colorectal cancer
Lead sponsor: Geriatric Oncology Consortium
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2005-07-15
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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;

Primary outcomes:
measure: 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:
measure: Overall response
measure: Duration of response
measure: Safety and tolerability (NCI CTCAE v3.0, discontinuations, dose intensity)
measure: Vulnerable Elders Survey (VES-13) and Geriatric Depression Scale (GDS) scores
Other outcomes:
Locations:
city: Mission Hills
country: United States
state: California
city: Washington
country: United States
state: District of Columbia
city: Inverness
country: United States
state: Florida
city: New Port Richey
country: United States
state: Florida
city: Coeur D'Alene
country: United States
state: Idaho
Study officials:
affiliation: Geriatric Oncology Consortium
name: Stuart Lichtman, MD
role: STUDY_CHAIR
References: