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TerminatedNCT00070265Updated Jan 24, 2013

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

A Phase 2 interventional study of oxaliplatin and capecitabine in Liver Metastases, Recurrent Colon Cancer and Recurrent Rectal Cancer, sponsored by National Cancer Institute (NCI). Terminated at 1 site in United States. Per ClinicalTrials.gov, last updated 2013-01-24.

Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment

Why this study was terminated
Administratively complete.
Phase
Phase 2
Study type
Interventional
Enrollment
80
Allocation
Not applicable
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Liver Metastases
  • Recurrent Colon Cancer
  • Recurrent Rectal Cancer
  • Stage IV Colon Cancer
  • Stage IV Rectal Cancer
03

In context

Neoplasm Metastasis

3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.

This study's enrollment of 80 is above the median of 54 across 2,767 interventional studies indexed under Neoplasm Metastasis.

Browse Neoplasm Metastasis studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.

Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    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.

    Drug: oxaliplatin · Drug: capecitabine · Procedure: therapeutic conventional surgery · Other: laboratory biomarker analysis

Interventions

  • Drugoxaliplatin

    Given IV

    Also known as: 1-OHP, Dacotin, Dacplat, Eloxatin, L-OHP

  • Drugcapecitabine

    Given orally

    Also known as: CAPE, Ro 09-1978/000, Xeloda

  • Proceduretherapeutic conventional surgery

    Undergo surgical resection

  • Otherlaboratory biomarker analysis

    Correlative studies

06

What researchers measure

Primary outcomes

  1. Rate of complete resection (R0 resection)

    The design of Thall and Simon will be used.

    Time frame: Up to 5 years

Secondary outcomes

  1. Response rate assessed using RECIST criteria

    Time frame: Up to 5 years

  2. Resectability in the subsets defined as resectable preoperatively

    Time frame: Up to 5 years

  3. Improvement in survival associated with downstaging based on metastatic colorectal prognostic score

    Time frame: Up to 5 years

  4. Disease-free survival

    Time frame: Up to 5 years

  5. Overall survival

    Time frame: Up to 5 years

  6. Positron emission tomography response rate

    Time frame: Up to 5 years

07

Study locations

1 site
  • University of Texas
    Houston, Texas 77030, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 24, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00070265
Lead sponsor
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Oct 7, 2003
Start date
Aug 2003
Primary completion
Sep 2004
Last update
Jan 24, 2013

Study contacts

Jean-Nicolas Vauthey
principal investigator · M.D. Anderson Cancer Center
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

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