NCT00070265

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 7, 2003

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2004

Completed
Last Updated

January 24, 2013

Status Verified

January 1, 2013

Enrollment Period

1.1 years

First QC Date

October 3, 2003

Last Update Submit

January 23, 2013

Conditions

Liver MetastasesRecurrent Colon CancerRecurrent Rectal CancerStage IV Colon CancerStage IV Rectal Cancer

Outcome Measures

Primary Outcomes (1)

  • Rate of complete resection (R0 resection)

    The design of Thall and Simon will be used.

    Up to 5 years

Secondary Outcomes (6)

  • Response rate assessed using RECIST criteria

    Up to 5 years

  • Resectability in the subsets defined as resectable preoperatively

    Up to 5 years

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

    Up to 5 years

  • Disease-free survival

    Up to 5 years

  • Overall survival

    Up to 5 years

  • +1 more secondary outcomes

Study Arms (1)

Treatment (oxaliplatin, capecitabine, and surgery)

EXPERIMENTAL

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: oxaliplatinDrug: capecitabineProcedure: therapeutic conventional surgeryOther: laboratory biomarker analysis

Interventions

oxaliplatinDRUG

Given IV

Also known as: 1-OHP, Dacotin, Dacplat, Eloxatin, L-OHP
Treatment (oxaliplatin, capecitabine, and surgery)
capecitabineDRUG

Given orally

Also known as: CAPE, Ro 09-1978/000, Xeloda
Treatment (oxaliplatin, capecitabine, and surgery)
therapeutic conventional surgeryPROCEDURE

Undergo surgical resection

Treatment (oxaliplatin, capecitabine, and surgery)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (oxaliplatin, capecitabine, and surgery)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +24 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Colonic NeoplasmsRectal Neoplasms

Interventions

OxaliplatinCapecitabine

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Jean-Nicolas Vauthey

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2003

First Posted

October 7, 2003

Study Start

August 1, 2003

Primary Completion

September 1, 2004

Last Updated

January 24, 2013

Record last verified: 2013-01

Locations

US(1)