search
Back to results

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

Primary Purpose

Liver Metastases, Recurrent Colon Cancer, Recurrent Rectal Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
oxaliplatin
capecitabine
therapeutic conventional surgery
laboratory biomarker analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Metastases

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Texas

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (oxaliplatin, capecitabine, and surgery)

Arm Description

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.

Outcomes

Primary Outcome Measures

Rate of complete resection (R0 resection)
The design of Thall and Simon will be used.

Secondary Outcome Measures

Response rate assessed using RECIST criteria
Resectability in the subsets defined as resectable preoperatively
Improvement in survival associated with downstaging based on metastatic colorectal prognostic score
Disease-free survival
Overall survival
Positron emission tomography response rate

Full Information

First Posted
October 3, 2003
Last Updated
January 23, 2013
Sponsor
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00070265
Brief Title
Neoadjuvant and Adjuvant Capecitabine and Oxaliplatin in Treating Patients With Resectable Liver Metastases Secondary to Colorectal Cancer
Official Title
A Multi-Institutional Phase II Trial Of Neoadjuvant Capecitabine (XELODA) And Oxaliplatin (ELOXATIN) For Resectable Colorectal Metastases In The Liver
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Terminated
Why Stopped
Administratively complete.
Study Start Date
August 2003 (undefined)
Primary Completion Date
September 2004 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Metastases, Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage IV Colon Cancer, Stage IV Rectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (oxaliplatin, capecitabine, and surgery)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
oxaliplatin
Other Intervention Name(s)
1-OHP, Dacotin, Dacplat, Eloxatin, L-OHP
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
capecitabine
Other Intervention Name(s)
CAPE, Ro 09-1978/000, Xeloda
Intervention Description
Given orally
Intervention Type
Procedure
Intervention Name(s)
therapeutic conventional surgery
Intervention Description
Undergo surgical resection
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Rate of complete resection (R0 resection)
Description
The design of Thall and Simon will be used.
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
Response rate assessed using RECIST criteria
Time Frame
Up to 5 years
Title
Resectability in the subsets defined as resectable preoperatively
Time Frame
Up to 5 years
Title
Improvement in survival associated with downstaging based on metastatic colorectal prognostic score
Time Frame
Up to 5 years
Title
Disease-free survival
Time Frame
Up to 5 years
Title
Overall survival
Time Frame
Up to 5 years
Title
Positron emission tomography response rate
Time Frame
Up to 5 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Nicolas Vauthey
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs