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A Phase II Study of Oxaliplatin, Capecitabine, and Bevacizumab in the Treatment of Elderly Patients With Metastatic Colorectal Cancer


Phase 2
65 Years
N/A
Not Enrolling
Both
Colorectal Cancer, Neoplasm Metastasis

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Trial Information

A Phase II Study of Oxaliplatin, Capecitabine, and Bevacizumab in the Treatment of Elderly Patients With Metastatic Colorectal Cancer


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.


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;

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome 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.

Principal Investigator

Stuart Lichtman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Geriatric Oncology Consortium

Authority:

United States: Institutional Review Board

Study ID:

GOC-GI-010

NCT ID:

NCT00120172

Start Date:

May 2005

Completion Date:

June 2006

Related Keywords:

  • Colorectal Cancer
  • Neoplasm Metastasis
  • colorectal
  • metastatic
  • elderly
  • metastatic colorectal cancer
  • Neoplasms
  • Colorectal Neoplasms
  • Neoplasm Metastasis

Name

Location
Fountain Valley, California  92708
Miami, Florida  33176
Washington, District of Columbia  
Coeur D'alene, Idaho  83814