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Oxaliplatin, Capecitabine, and Bevacizumab Followed By Surgery and/or Radiofrequency Ablation in Patients With Colorectal Cancer

This study has been withdrawn prior to enrollment.
(Lack of accrual)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00408772
First Posted: December 7, 2006
Last Update Posted: June 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Sanofi
Information provided by (Responsible Party):
University of California, Davis
  Purpose

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, 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 block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Radiofrequency ablation uses a high-frequency, electric current to kill tumor cells. Giving chemotherapy and bevacizumab before surgery or radiofrequency ablation may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase II trial is studying how well giving oxaliplatin and capecitabine together with bevacizumab followed by surgery and/or radiofrequency ablation works in treating patients with colorectal cancer that has spread to the liver and cannot be removed by surgery.


Condition Intervention Phase
Colorectal Cancer Metastatic Cancer Biological: bevacizumab Drug: capecitabine Drug: oxaliplatin Procedure: conventional surgery Procedure: neoadjuvant therapy Procedure: radiofrequency ablation Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Neoadjuvant XELOX/AVASTIN Therapy for Nonresectable Colorectal Liver Metastases With Secondary Hepatic Resection/Radiofrequency

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Conversion rate of nonresectable disease to resectable disease [ Time Frame: 48 months ]

Secondary Outcome Measures:
  • Disease-free and overall survival [ Time Frame: 48 months ]
  • Objective response rate [ Time Frame: 48 months ]
  • Duration of response [ Time Frame: 48 months ]

Enrollment: 0
Study Start Date: June 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Unresectable colorectal liver mets Biological: bevacizumab Drug: capecitabine Drug: oxaliplatin Procedure: conventional surgery Procedure: neoadjuvant therapy Procedure: radiofrequency ablation

Detailed Description:

OBJECTIVES:

Primary

  • Evaluate the conversion rate of nonresectable disease to resectable disease in patients with nonresectable liver metastases secondary to colorectal adenocarcinoma treated with neoadjuvant therapy comprising oxaliplatin, capecitabine, and bevacizumab followed by hepatic resection and/or radiofrequency ablation.
  • Evaluate progression-free survival of patients treated with this regimen.

Secondary

  • Determine disease-free and overall survival of patients treated with this regimen.
  • Determine the toxicities of this regimen in these patients.

OUTLINE:

  • Neoadjuvant therapy: Patients receive oxaliplatin IV over 2 hours and bevacizumab IV over 1 hour on day 1 and oral capecitabine twice daily on days 1-14. Treatment repeats every 3 weeks for 4-6 courses in the absence of disease progression or unacceptable toxicity or until conversion to resectable disease.
  • Surgery and/or radiofrequency ablation (RFA): Patients undergo hepatic resection (with or without RFA) when tumor is deemed resectable. Patients with stable (< 8 lesions) and unresectable disease undergo laparoscopic or percutaneous RFA. RFA repeats once 4-6 weeks later.
  • Adjuvant therapy: Beginning 6-8 weeks after surgery and/or RFA, patients may receive adjuvant therapy comprising oxaliplatin, capecitabine, and bevacizumab, as in neoadjuvant therapy, for up to 4 courses.

After completion of study treatment, patients are followed every 4 months.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed colorectal adenocarcinoma metastatic to the liver

    • Unresectable liver metastases
  • Measurable disease
  • No evidence of extrahepatic metastases
  • No CNS metastases

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • Absolute neutrophil count > 1,500/mm^3
  • Platelet count > 100,000/mm^3
  • Creatinine ≤ 1.5 times upper limit of normal (ULN) OR creatinine clearance ≥ 45 mL/min
  • Urinary protein < 2+ by dipstick OR < 2 g by 24-hour urine collection
  • Bilirubin < 2 times ULN
  • SGOT and SGPT < 2 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 18 months after completion of study therapy
  • Able to take oral medications (e.g., no dysphagia or malabsorption symptoms)
  • No other prior malignancy unless in complete remission and off therapy for ≥ 5 years
  • No known allergy to the study drugs
  • No peripheral neuropathy > grade 1
  • No uncontrolled infection
  • No uncontrolled hypertension
  • No active bleeding or hemoptysis
  • No other serious concurrent illness within the past 12 months, including any of the following:

    • Nonstable coronary artery disease
    • Myocardial infarction
    • Transient ischemic attack
    • Cardiovascular accident

PRIOR CONCURRENT THERAPY:

  • Recovered from prior therapy
  • At least 28 days since prior major surgery
  • Prior therapy for advanced disease allowed

    • No prior oxaliplatin-based therapy
  • Concurrent maintenance and palliative treatment during study chemotherapy allowed (e.g., nutritional or transfusional support or pain control)
  • No concurrent corticosteroids except when used under the following circumstances:

    • As oxaliplatin premedication
    • Anti-5-HT_3 as antiemetic
  • No concurrent cold cap or iced mouth rinses
  • No other concurrent chemotherapy
  • No placement of hepatic artery port for regional chemotherapy
  Contacts and Locations
Information from the National Library of Medicine

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): NCT00408772


Locations
United States, California
University of California Davis Cancer Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Sanofi
Investigators
Principal Investigator: Vijay Khatri, MD, FACS University of California, Davis
  More Information

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00408772     History of Changes
Other Study ID Numbers: 200412546
UCDCC#131 ( Other Identifier: University of California Davis )
CDR0000517440 ( Other Identifier: UC Davis )
First Submitted: December 6, 2006
First Posted: December 7, 2006
Last Update Posted: June 9, 2017
Last Verified: June 2017

Keywords provided by University of California, Davis:
liver metastases
stage IV colon cancer
stage IV rectal cancer
adenocarcinoma of the colon
adenocarcinoma of the rectum
recurrent colon cancer
recurrent rectal cancer

Additional relevant MeSH terms:
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
Oxaliplatin
Capecitabine
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action