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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
N/A
Not Enrolling
Both
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


OBJECTIVES:

- 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
regimen.

- 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
regimen.

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

- 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


DISEASE CHARACTERISTICS:

- 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
scan

- 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

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Zubrod 0-1

Life expectancy

- Not specified

Hematopoietic

- Hemoglobin ≥ 9.0 g/dL

- WBC ≥ 3,000/mm^3

- Platelet count ≥ 100,000/mm^3

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

Hepatic

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

- SGOT or SGPT ≤ 2.5 times ULN

Renal

- Creatinine clearance ≥ 60 mL/min

- Urine protein/creatinine ratio < 1 OR

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

Cardiovascular

- 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
following:

- Transient ischemic attack

- Cerebrovascular accident

- Unstable angina

- Myocardial infarction

- No peripheral vascular disease ≥ grade 2

Other

- 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- 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

Radiotherapy

- No prior radiotherapy for metastatic disease

Surgery

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

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

Other

- 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
allowed

Type of Study:

Interventional

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:

No

Principal Investigator

Jean-Nicolas Vauthey, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000433491

NCT ID:

NCT00118105

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

Name

Location

CCOP - Carle Cancer CenterUrbana, Illinois  61801
Rush-Copley Cancer Care CenterAurora, Illinois  60507
Joliet Oncology-Hematology Associates, Limited - WestJoliet, Illinois  60435
Carle Cancer Center at Carle Foundation HospitalUrbana, Illinois  61801
Saint Anthony Memorial Health CentersMichigan City, Indiana  46360
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
St. Rita's Medical CenterLima, Ohio  45801
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
CCOP - DaytonKettering, Ohio  45429
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Great Falls ClinicGreat Falls, Montana  59405
Cancer Research Center at Boston Medical CenterBoston, Massachusetts  02118
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
St. Vincent HealthcareBillings, Montana  59101
Deaconess Billings Clinic - DowntownBillings, Montana  59101
St. James Community HospitalButte, Montana  59701
St. Peter's HospitalHelena, Montana  59601
Kalispell Medical OncologyKalispell, Montana  59901
Kalispell Regional Medical CenterKalispell, Montana  59901
Glacier Oncology, PLLCKalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoula, Montana  59802
Montana Cancer Specialists at Montana Cancer CenterMissoula, Montana  59802
Community Medical CenterMissoula, Montana  59801
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
St. Francis Hospital and Health Centers - Beech Grove CampusBeech Grove, Indiana  46107
Reid Hospital & Health Care Services, IncorporatedRichmond, Indiana  47374
Samaritan North Cancer Care CenterDayton, Ohio  45415
Grandview HospitalDayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley HospitalDayton, Ohio  45409
Good Samaritan HospitalDayton, Ohio  45406
Blanchard Valley Medical AssociatesFindlay, Ohio  45840
Charles F. Kettering Memorial HospitalKettering, Ohio  45429
Middletown Regional HospitalMiddletown, Ohio  45044
UVMC Cancer Care Center at Upper Valley Medical CenterTroy, Ohio  45373-1300
Ruth G. McMillan Cancer Center at Greene Memorial HospitalXenia, Ohio  45385
Danville Regional Medical CenterDanville, Virginia  24541
Welch Cancer Center at Sheridan Memorial HospitalSheridan, Wyoming  82801
Tammy Walker Cancer Center at Salina Regional Health CenterSalina, Kansas  67401
Bozeman Deaconess Cancer CenterBozeman, Montana  59715
Billings Clinic Cancer CenterBillings, Montana  59107-5100
Guardian Oncology and Center for WellnessMissoula, Montana  59804
Frontier Cancer CenterGreat Falls, Montana  59405