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Liver MetastasesPhase 2NCT00070265

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

A Phase 2 study testing oxaliplatin, capecitabine and therapeutic conventional surgery in people with Liver Metastases and Recurrent Colon Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
What is being tested?
oxaliplatin, capecitabine and therapeutic conventional surgery
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteUnited States
Study dates
Aug 2003to Sep 2004
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Texas

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: A Multi-Institutional Phase II Trial Of Neoadjuvant Capecitabine (XELODA) And Oxaliplatin (ELOXATIN) For Resectable Colorectal Metastases In The Liver

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:

  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.

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

SECONDARY OBJECTIVES:

  1. 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.

  1. 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.

Being tested
oxaliplatin, capecitabine, therapeutic conventional surgery, laboratory biomarker analysis
Medical subject headings
Colonic Neoplasms, Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00070265
Study groupRoleWhat they receive
Treatment (oxaliplatin, capecitabine, and surgery)ExperimentalNeoadjuvant 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.
Receives: Drug: oxaliplatin; Drug: capecitabine; Procedure: therapeutic conventional surgery; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of complete resection (R0 resection)

    The design of Thall and Simon will be used.

    Measured: Up to 5 years

Secondary outcomes (6)

  1. Response rate assessed using RECIST criteria

    Measured: Up to 5 years

  2. Resectability in the subsets defined as resectable preoperatively

    Measured: Up to 5 years

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

    Measured: Up to 5 years

  4. Disease-free survival

    Measured: Up to 5 years

  5. Overall survival

    Measured: Up to 5 years

  6. Positron emission tomography response rate

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Oct 2003 (estimated)
  2. Study startAug 2003
  3. Primary completionSep 2004

Why it stopped: Administratively complete.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00070265
Sponsor's protocol ID
NCI-2012-02722
Other IDs
MDA-ID-02636, N01CM17003, CDR0000331853
Status last verified
Jan 2013
First submitted
3 Oct 2003
Last updated
24 Jan 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing oxaliplatin, capecitabine and therapeutic conventional surgery in people with Liver Metastases and Recurrent Colon Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 39 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 24 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Administratively complete.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of complete resection (R0 resection) (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00070265.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2013.

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