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

November 15, 2007 updated by: Geriatric Oncology Consortium

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Mission Hills, California, United States, 91345
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
    • Florida
      • Inverness, Florida, United States, 34452
      • New Port Richey, Florida, United States, 34652
    • Idaho
      • Coeur D'Alene, Idaho, United States, 83814

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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.

Secondary Outcome Measures

Outcome Measure
Duration of response
Overall response
Safety and tolerability (NCI CTCAE v3.0, discontinuations, dose intensity)
Vulnerable Elders Survey (VES-13) and Geriatric Depression Scale (GDS) scores

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Geriatric Oncology Consortium

Collaborators

Sanofi

Investigators

  • Study Chair: Stuart Lichtman, MD, Geriatric Oncology Consortium

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Study Completion (Actual)

June 1, 2006

Study Registration Dates

First Submitted

July 8, 2005

First Submitted That Met QC Criteria

July 8, 2005

First Posted (Estimate)

July 15, 2005

Study Record Updates

Last Update Posted (Estimate)

November 16, 2007

Last Update Submitted That Met QC Criteria

November 15, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GOC-GI-010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Neoplasm Metastasis

Clinical Trials on oxaliplatin, capecitabine, bevacizumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sri Lanka

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe