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Neoadjuvant and Adjuvant Capecitabine and Oxaliplatin in Treating Patients With Resectable Liver Metastases Secondary to Colorectal Cancer
This study has been completed.
Study NCT00070265   Information provided by National Cancer Institute (NCI)
First Received: October 3, 2003   Last Updated: February 6, 2009   History of Changes

October 3, 2003
February 6, 2009
 
 
 
 
Complete list of historical versions of study NCT00070265 on ClinicalTrials.gov Archive Site
 
 
 
Neoadjuvant and Adjuvant Capecitabine and Oxaliplatin in Treating Patients With Resectable Liver Metastases Secondary to Colorectal Cancer
A Multi-Institutional Phase II Trial Of Neoadjuvant Capecitabine (XELODA) And Oxaliplatin (ELOXATIN) For Resectable Colorectal Metastases In The Liver

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.

OBJECTIVES:

Primary

  • Determine the efficacy and toxicity of neoadjuvant and adjuvant capecitabine and oxaliplatin in patients with resectable liver metastases secondary to colorectal cancer who are undergoing surgery.
  • Determine the rates of R0 resection in patients treated with this regimen before surgery.

Secondary

  • Determine the response rate in patients treated with this regimen.
  • Determine the resectability in the subsets of patients defined as resectable preoperatively and treated with this regimen.
  • Determine improvement in survival associated with downstaging based on metastatic colorectal prognostic score in patients treated with this regimen.
  • Determine the disease-free and overall survival of patients treated with this regimen.
  • Correlate drug-specific biomarkers with clinical response in patients treated with this regimen.

OUTLINE: This is a multicenter study.

  • Neoadjuvant chemotherapy: Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
  • Surgery: Four to six weeks after the completion of chemotherapy, patients undergo surgical resection of the tumor.
  • Adjuvant chemotherapy: Patients with satisfactory response to therapy receive 4 additional courses of oxaliplatin and capecitabine after surgery.

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.

Phase II
Interventional
Masking:  Open Label
Primary Purpose:  Treatment
  • Colorectal Cancer
  • Metastatic Cancer
  • Drug: capecitabine
  • Drug: oxaliplatin
  • Procedure: adjuvant therapy
  • Procedure: conventional surgery
  • Procedure: neoadjuvant therapy
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

DISEASE CHARACTERISTICS:

  • Histologically confirmed hepatic colorectal metastasis by percutaneous hepatic biopsy

    • Imaging evidence of liver metastasis by CT helical scan
  • Resectable disease, as determined by a surgeon with hepatic surgery expertise (at least 10 resections performed per year)

    • Resectable, defined as a sparing of 2 adjacent liver segments with adequate vascular inflow and outflow and hepatic remnant volume
    • Minor resections (less than a hemihepatectomy) or major resections (hemihepatectomy or extended hepatectomy) allowed
    • Bilobar resection allowed, including atypical resections
  • No evidence of extrahepatic disease by chest x-ray or CT scan of the chest, abdomen, and pelvis

PATIENT CHARACTERISTICS:

Age

  • Not specified

Performance status

  • Zubrod 0-1

Life expectancy

  • Not specified

Hematopoietic

  • WBC at least 3,000/mm^3
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 9.0 g/dL

Hepatic

  • Bilirubin no greater than 2 mg/dL
  • AST and ALT no greater than 300 IU/L
  • No preexisting chronic hepatic disease (e.g., chronic active hepatitis or cirrhosis) that would preclude surgical resection of metastases

Renal

  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance 60 mL/min

Cardiovascular

  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other malignancy within the past 5 years except completely resected nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No preexisting grade 2 or greater peripheral neuropathy
  • No concurrent uncontrolled illness
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent biologic therapy
  • No concurrent sargramostim (GM-CSF)

Chemotherapy

  • More than 6 months since prior adjuvant fluorouracil-based chemotherapy
  • No prior chemotherapy for liver metastasis
  • No prior oxaliplatin for colorectal cancer
  • No prior or concurrent hepatic artery infusion chemotherapy for metastatic disease

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior or concurrent radiotherapy for metastatic disease

Surgery

  • No prior or concurrent radiofrequency ablation for metastatic disease
  • No prior or concurrent cryotherapy/other ablative techniques for metastatic disease

Other

  • No other concurrent investigational therapy
  • No concurrent oral anticoagulation
Both
 
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00070265
 
CDR0000331853, MDA-ID-02636, NCI-6021
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study Chair: Jean-Nicolas Vauthey, MD M.D. Anderson Cancer Center
National Cancer Institute (NCI)
January 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP