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

NCT ID: NCT00070265

Last Updated: 2013-01-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-08-31

Brief Summary

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. 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

Detailed Description

PRIMARY OBJECTIVES:

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 surgery.

SECONDARY OBJECTIVES:

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 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.

Conditions

Liver Metastases; Recurrent Colon Cancer; Recurrent Rectal Cancer; Stage IV Colon Cancer; Stage IV Rectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (oxaliplatin, capecitabine, and surgery)

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.

Group Type: EXPERIMENTAL

oxaliplatin

Intervention Type: DRUG

Given IV

capecitabine

Intervention Type: DRUG

Given orally

therapeutic conventional surgery

Intervention Type: PROCEDURE

Undergo surgical resection

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

Interventions

oxaliplatin

Given IV

Intervention Type: DRUG

capecitabine

Given orally

Intervention Type: DRUG

therapeutic conventional surgery

Undergo surgical resection

Intervention Type: PROCEDURE

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

Other Intervention Names

1-OHP; Dacotin; Dacplat; Eloxatin; L-OHP; CAPE; Ro 09-1978/000; Xeloda

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Nicolas Vauthey

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

University of Texas

Houston, Texas, United States

Countries

United States

Other Identifiers

MDA-ID-02636

Identifier Type: -

Identifier Source: secondary_id

N01CM17003

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDR0000331853

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2012-02722

Identifier Type: -

Identifier Source: org_study_id