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A Multi-Institutional Phase II Trial Of Neoadjuvant Capecitabine (XELODA) And Oxaliplatin (ELOXATIN) For Resectable Colorectal Metastases In The Liver

Phase 2
Not Enrolling
Liver Metastases, Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage IV Colon Cancer, Stage IV Rectal Cancer

Thank you

Trial Information

A Multi-Institutional Phase II Trial Of Neoadjuvant Capecitabine (XELODA) And Oxaliplatin (ELOXATIN) For Resectable Colorectal Metastases In The Liver


I. 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.

II. Determine the rates of R0 resection in patients treated with this regimen before


I. Determine the response rate in patients treated with this regimen. II. Determine the
resectability in the subsets of patients defined as resectable preoperatively and treated
with this regimen.

III. Determine improvement in survival associated with downstaging based on metastatic
colorectal prognostic score in patients treated with this regimen.

IV. Determine the disease-free and overall survival of patients treated with this regimen.

V. Correlate drug-specific biomarkers with clinical response in patients treated with this

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.

Inclusion Criteria:

- 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

- Performance status - Zubrod 0-1

- 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

- 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

- Creatinine no greater than 1.5 mg/dL

- Creatinine clearance 60 mL/min

- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia

- 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

- No concurrent biologic therapy

- No concurrent sargramostim (GM-CSF)

- 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

- No prior or concurrent radiotherapy for metastatic disease

- No prior or concurrent radiofrequency ablation for metastatic disease

- No prior or concurrent cryotherapy/other ablative techniques for metastatic disease

- No other concurrent investigational therapy

- No concurrent oral anticoagulation

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Rate of complete resection (R0 resection)

Outcome Description:

The design of Thall and Simon will be used.

Outcome Time Frame:

Up to 5 years

Safety Issue:


Principal Investigator

Jean-Nicolas Vauthey

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

August 2003

Completion Date:

Related Keywords:

  • Liver Metastases
  • Recurrent Colon Cancer
  • Recurrent Rectal Cancer
  • Stage IV Colon Cancer
  • Stage IV Rectal Cancer
  • Colonic Neoplasms
  • Rectal Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Liver Neoplasms



University of Texas Houston, Texas  77225