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Capecitabine, Oxaliplatin, and Bevacizumab in Treating Patients With Metastatic or Recurrent Colorectal Cancer
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Duke University
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00416494
  Purpose

RATIONALE: Drugs used in chemotherapy, such as capecitabine, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving capecitabine and oxaliplatin together with bevacizumab may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving oxaliplatin and capecitabine together with bevacizumab works in treating patients with metastatic or recurrent colorectal cancer.


Condition Intervention Phase
Colorectal Cancer
Drug: bevacizumab
Drug: capecitabine
Drug: oxaliplatin
Phase II

MedlinePlus related topics: Cancer Colorectal Cancer
Drug Information available for: Capecitabine Bevacizumab Oxaliplatin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Study of Oxaliplatin, Capecitabine and Bevacizumab in the Treatment of Metastatic Colorectal Cancer

Further study details as provided by National Cancer Institute (NCI):

Detailed Description:

OBJECTIVES:

Primary

  • Evaluate the response rate in patients with previously untreated metastatic colorectal cancer treated with capecitabine, oxaliplatin, and bevacizumab.
  • Assess the safety and tolerability of bevacizumab, oxaliplatin, and capecitabine in patients with previously untreated metastatic colorectal cancer.

Secondary

  • Assess time to progression (TTP), disease-free survival (DFS), and overall survival (OS) in patients treated with this regimen.
  • Evaluate the effect of this regimen on the biomarkers of angiogenesis.
  • Assess the effect of this regimen on wound angiogenesis.

OUTLINE: Patients receive oral capecitabine twice daily on days 1-5 and 8-12, oxaliplatin IV over 2 hours on day 1, and bevacizumab IV over 1-1½ hours on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically documented adenocarcinoma of the colon or rectum

    • Metastatic or recurrent disease not amenable to potentially curative treatment (e.g., inoperable metastatic disease)
  • No leptomeningeal or brain metastases

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Absolute neutrophil count ≥ 2,000/mm^3
  • Platelet count ≥ 100,000/mm^3
  • AST/ALT < 2.5 times upper limit of normal (ULN) (5 times ULN if known liver metastases)
  • Bilirubin < 1.5 times ULN
  • Creatinine clearance > 50 mL/min
  • No unstable or poorly controlled hypertension (> 150/100 mm Hg)

    • Patients who have recently started or adjusted antihypertensive medications are eligible provided blood pressure is < 140/90 mm Hg on any new regimen for at least 3 different observations over 14 days
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during study and for at least 3-4 months after study completion
  • No arterial or venous thrombosis (including cerebrovascular accident) within the last 3 months
  • No known, existing, uncontrolled coagulopathy
  • No clinically significant cardiac disease
  • No congestive heart failure
  • No symptomatic coronary artery disease
  • No cardiac arrhythmias not well controlled with medication
  • No myocardial infarction within the last 12 months
  • No history of allergic reactions attributed to compounds of similar chemical or biologic composition to oxaliplatin, capecitabine, or bevacizumab
  • No history of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the patient at high risk from treatment complications

PRIOR CONCURRENT THERAPY:

  • At least 4 weeks since prior sorivudine or brivudine
  • At least 6 months since prior adjuvant treatment with fluorouracil and leucovorin calcium or a fluorouracil and leucovorin calcium-based regimen
  • No major surgery within 4 weeks without complete recovery
  • No prior chemotherapy for metastatic/recurrent disease
  • No cancer immunotherapy or other biologic therapy while on therapy
  • No radiotherapy while on study
  • No hormonal therapy for cancer while on study
  • No full-dose warfarin (INR of > 1.5), heparin (> 10,000 units/day), or thrombolytic agents
  • Allopurinol and cimetidine should be discontinued prior to starting on this regimen
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00416494

Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Herbert I. Hurwitz, MD Duke University
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications of Results:
Hurwitz H, Fernando N, Yu D, et al.: A phase II study of oxaliplatin, capecitabine and bevacizumab in the treatment of metastatic colorectal cancer. [Abstract] Ann Oncol 16 (Suppl 2): A-55P, ii285, 2005.

Study ID Numbers: CDR0000449971, DUMC-4951-05-7R2, GENENTECH-DUMC-4951-05-7R2, SANOFI-DUMC-4951-05-7R2, ROCHE-DUMC-4951-05-7R2
Study First Received: December 27, 2006
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00416494  
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the colon
recurrent colon cancer
stage IV colon cancer
adenocarcinoma of the rectum
recurrent rectal cancer
stage IV rectal cancer

Study placed in the following topic categories:
Capecitabine
Digestive System Neoplasms
Rectal Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Bevacizumab
Intestinal Diseases
Rectal Diseases
Recurrence
Intestinal Neoplasms
Rectal neoplasm
Oxaliplatin
Digestive System Diseases
Gastrointestinal Neoplasms
Adenocarcinoma
Rectal cancer
Colorectal Neoplasms

Additional relevant MeSH terms:
Antimetabolites
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Angiogenesis Modulating Agents
Growth Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009