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

This study has been terminated.
(positive results from a larger study with same regimen was released.)
Sponsor:
Collaborator:
Sanofi
Information provided by:
Geriatric Oncology Consortium
ClinicalTrials.gov Identifier:
NCT00120172
First received: July 8, 2005
Last updated: November 15, 2007
Last verified: November 2007
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
Neoplasm Metastasis
Drug: oxaliplatin, capecitabine, bevacizumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Oxaliplatin, Capecitabine, and Bevacizumab in the Treatment of Elderly Patients With Metastatic Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Geriatric Oncology Consortium:

Primary Outcome Measures:
  • 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:
  • 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

Estimated Enrollment: 40
Study Start Date: May 2005
Study Completion Date: June 2006
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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00120172

Locations
United States, California
Mission Hills, California, United States, 91345
United States, District of Columbia
Washington, District of Columbia, United States, 20007
United States, Florida
Inverness, Florida, United States, 34452
New Port Richey, Florida, United States, 34652
United States, Idaho
Coeur D'Alene, Idaho, United States, 83814
Sponsors and Collaborators
Geriatric Oncology Consortium
Sanofi
Investigators
Study Chair: Stuart Lichtman, MD Geriatric Oncology Consortium
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00120172     History of Changes
Other Study ID Numbers: GOC-GI-010
Study First Received: July 8, 2005
Last Updated: November 15, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Geriatric Oncology Consortium:
colorectal
metastatic
elderly
metastatic colorectal cancer

Additional relevant MeSH terms:
Neoplasms
Colorectal Neoplasms
Neoplasm Metastasis
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Oxaliplatin
Capecitabine
Bevacizumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014