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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00120172
• Other study ID #: GOC-GI-010
• Status: Terminated
• Phase: Phase 2
• First received: July 8, 2005
• Last updated: November 15, 2007
• Start date: May 2005
• Est. completion date: June 2006

Study information

• Verified date: November 2007
• Source: Geriatric Oncology Consortium
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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;

Study Design

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Neoplasm Metastasis

Intervention

Drug:
• oxaliplatin, capecitabine, bevacizumab

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Geriatric Oncology Consortium	Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall response
Secondary	Duration of response
Secondary	Safety and tolerability (NCI CTCAE v3.0, discontinuations, dose intensity)
Secondary	Vulnerable Elders Survey (VES-13) and Geriatric Depression Scale (GDS) scores