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

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ClinicalTrials.gov Identifier: NCT00120172
Recruitment Status : Terminated (positive results from a larger study with same regimen was released.)
First Posted : July 15, 2005
Last Update Posted : November 16, 2007
Sponsor:
Collaborator:
Sanofi
Information provided by:
Geriatric Oncology Consortium

Study Description
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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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Neoplasm Metastasis Drug: oxaliplatin, capecitabine, bevacizumab Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 2005
Actual Study Completion Date : June 2006

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. Overall response
  2. Duration of response
  3. Safety and tolerability (NCI CTCAE v3.0, discontinuations, dose intensity)
  4. Vulnerable Elders Survey (VES-13) and Geriatric Depression Scale (GDS) scores

Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00120172


Locations
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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
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Study Chair: Stuart Lichtman, MD Geriatric Oncology Consortium
More Information
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ClinicalTrials.gov Identifier: NCT00120172     History of Changes
Other Study ID Numbers: GOC-GI-010
First Posted: July 15, 2005    Key Record Dates
Last Update Posted: November 16, 2007
Last Verified: November 2007
Keywords provided by Geriatric Oncology Consortium:
colorectal
metastatic
elderly
metastatic colorectal cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Neoplasm Metastasis
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
 Bevacizumab
Capecitabine
Oxaliplatin
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action