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Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00070265 |
RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Giving capecitabine and oxaliplatin before surgery may shrink the tumor so that it can be removed. Giving capecitabine and oxaliplatin after surgery may kill any remaining tumor cells.
PURPOSE: This phase II trial is studying how well capecitabine and oxaliplatin work when given before and after surgery in treating patients with resectable liver metastases that is secondary to colorectal cancer.
Condition | Intervention | Phase |
---|---|---|
Colorectal Cancer Metastatic Cancer |
Drug: capecitabine Drug: oxaliplatin Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Multi-Institutional Phase II Trial Of Neoadjuvant Capecitabine (XELODA) And Oxaliplatin (ELOXATIN) For Resectable Colorectal Metastases In The Liver |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients are followed at 4-6 weeks after surgery, every 3 months for 2 years, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A maximum of 80 patients will be accrued for this study.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed hepatic colorectal metastasis by percutaneous hepatic biopsy
Resectable disease, as determined by a surgeon with hepatic surgery expertise (at least 10 resections performed per year)
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Study ID Numbers: | CDR0000331853, MDA-ID-02636, NCI-6021 |
Study First Received: | October 3, 2003 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00070265 |
Health Authority: | United States: Federal Government |
liver metastases stage IV colon cancer stage IV rectal cancer recurrent colon cancer recurrent rectal cancer |
Capecitabine Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Recurrence |
Intestinal Neoplasms Rectal neoplasm Oxaliplatin Digestive System Diseases Neoplasm Metastasis Gastrointestinal Neoplasms Rectal cancer Colorectal Neoplasms |
Antimetabolites Neoplastic Processes Neoplasms Antimetabolites, Antineoplastic Pathologic Processes |
Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |