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A Phase II Trial of Neoadjuvant Capecitabine, Oxaliplatin, and Bevacizumab for Resectable Colorectal Metastases in the Liver

Phase 2
18 Years
Not Enrolling
Colorectal Cancer, Metastatic Cancer

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Trial Information

A Phase II Trial of Neoadjuvant Capecitabine, Oxaliplatin, and Bevacizumab for Resectable Colorectal Metastases in the Liver


- Determine the proportion of patients with resectable hepatic metastases secondary to
colorectal cancer who undergo surgical resection and achieve a R0 resection after
treatment with neoadjuvant capecitabine, oxaliplatin, and bevacizumab.

- Determine the probability of non-progression (i.e., stable disease or response
[complete and partial, confirmed and unconfirmed]) in patients treated with this

- Compare the proportion of patients treated with this regimen who undergo surgical
resection and those who achieve a R0 resection with that described in the literature.

- Determine overall survival and disease-free survival of patients treated with this

- Determine response by positron emission tomography in patients treated with this

- Correlate clinical outcome with expression of biomarkers (e.g., thymidylate synthase,
dihydropyrimidine dehydrogenase, thymidine phosphorylase, excision repair cross
complementing 1, and hTERT) and telomere length in patients treated with this regimen.

OUTLINE: This is a multicenter study.

- Neoadjuvant therapy: Patients receive bevacizumab* IV over 30-90 minutes and
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.

NOTE: *Bevacizumab is administered during courses 1-3 of neoadjuvant therapy.

- Surgery: Approximately 3-4 weeks after completion of neoadjuvant therapy, patients are
evaluated. Patients with unresectable disease are removed from the study. Patients with
resectable disease undergo surgical resection of liver metastases within 4-6 weeks
after completion of neoadjuvant therapy.

- Adjuvant therapy: Beginning at least 28 days after surgical resection, patients with at
least stable disease after completion of neoadjuvant therapy receive 4 courses of
adjuvant bevacizumab**, oxaliplatin, and capecitabine as in neoadjuvant therapy.

NOTE: **Bevacizumab is administered during courses 1-4 of adjuvant therapy.

After completion of study treatment, patients are followed every 4 months until disease
progression and then every 6 months for up to 3 years from study entry.

PROJECTED ACCRUAL: Approximately 35-65 patients will be accrued for this study.

Inclusion Criteria


- Diagnosis of hepatic metastases secondary to colorectal cancer by percutaneous
hepatic biopsy

- Resectable hepatic metastases by any of the following:

- Minor resection (i.e., less than a hemihepatectomy)

- Major resection (i.e., hemihepatectomy or extended hepatectomy)

- Bilobar resection (including atypical resection)

- Synchronous primary tumor and hepatic metastases allowed

- Radiologic evidence of hepatic metastases by multiphasic contrast-enhanced spiral CT

- Resectable primary colorectal cancer that is in place allowed

- Measurable disease

- No evidence of extrahepatic metastases by chest x-ray or CT scan of the chest



- 18 and over

Performance status

- Zubrod 0-1

Life expectancy

- Not specified


- Hemoglobin ≥ 9.0 g/dL

- WBC ≥ 3,000/mm^3

- Platelet count ≥ 100,000/mm^3

- Absolute neutrophil count ≥ 1,500/mm^3


- Bilirubin ≤ 2 times upper limit of normal (ULN)

- SGOT or SGPT ≤ 2.5 times ULN


- Creatinine clearance ≥ 60 mL/min

- Urine protein/creatinine ratio < 1 OR

- Urine protein < 1 g by 24-hour urine collection


- No uncontrolled hypertension (i.e., blood pressure > 150/90 mm Hg)

- History of hypertension allowed provided it is well controlled on a stable
regimen of anti-hypertensive therapy

- No arterial thromboembolic event within the past 12 months, including any of the

- Transient ischemic attack

- Cerebrovascular accident

- Unstable angina

- Myocardial infarction

- No peripheral vascular disease ≥ grade 2


- Not pregnant or nursing

- Fertile patients must use effective contraception

- No pre-existing peripheral neuropathy ≥ grade 2

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer or carcinoma in situ of the cervix


Biologic therapy

- Not specified


- More than 6 months since prior adjuvant chemotherapy for the primary tumor

- No prior systemic chemotherapy for metastatic disease

- No prior hepatic artery infusion chemotherapy for metastatic disease

Endocrine therapy

- Not specified


- No prior radiotherapy for metastatic disease


- More than 7 days since prior colonoscopy or fine needle aspiration

- More than 28 days since prior major invasive surgery or open biopsy


- At least 4 weeks since prior and no concurrent sorivudine or brivudine

- No prior radiofrequency ablation for metastatic disease

- No prior cryotherapy for metastatic disease

- No other prior ablative techniques for metastatic disease

- No concurrent cimetidine

- Concurrent ranitidine or other drug from a different antiulcer class allowed

- No concurrent oral anticoagulation for treatment of thrombosis

- Concurrent warfarin (1 mg) to maintain patency of central venous catheter

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of patients with R0 resection after treatment

Outcome Time Frame:

16-18 weeks from registration

Safety Issue:


Principal Investigator

Jean-Nicolas Vauthey, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Federal Government

Study ID:




Start Date:

November 2006

Completion Date:

April 2007

Related Keywords:

  • Colorectal Cancer
  • Metastatic Cancer
  • recurrent colon cancer
  • stage IV colon cancer
  • recurrent rectal cancer
  • stage IV rectal cancer
  • liver metastases
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary



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