Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Neoadjuvant and Adjuvant Capecitabine and Oxaliplatin in Treating Patients With Resectable Liver Metastases Secondary to Colorectal Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	Not specified	NCI	MDA-ID-02636 NCI-6021, NCT00070265, 6021

Objectives

Primary

1. 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.
2. Determine the rates of R0 resection in patients treated with this regimen before surgery.

Secondary

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

Entry Criteria

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

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

Patient Characteristics:

Age

• Not specified

Performance status

• Zubrod 0-1

Life expectancy

• Not specified

Hematopoietic

• WBC at least 3,000/mm³
• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³
• 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

Expected Enrollment

A maximum of 80 patients will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

M. D. Anderson Cancer Center at University of Texas

Jean-Nicolas Vauthey, MD, Protocol chair		Ph: 713-792-2022; 800-392-1611 Email: jvauthey@mdanderson.org

Registry Information
Official Title		A Multi-Institutional Phase II Trial Of Neoadjuvant Capecitabine (XELODA) And Oxaliplatin (ELOXATIN) For Resectable Colorectal Metastases In The Liver
Registered in ClinicalTrials.gov		NCT00070265 1
Date Submitted to PDQ		2003-08-26
Information Last Verified		2004-01-09
NCI Grant/Contract Number		P30-CA16672, N01-CM17003

Table of Links

1	http://clinicaltrials.gov/ct/show/NCT00070265