Home
Clinical Trials
S0408: Capecitabine, Oxalipla...

S0408: Capecitabine, Oxaliplatin, and Bevacizumab in Pts Undergoing Surgery for Liver Mets From Colorectal Cancer

Last Updated: 2013-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2007-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving capecitabine and oxaliplatin together with bevacizumab before and after surgery may be an effective treatment for liver metastases.

PURPOSE: This phase II trial is studying how well giving capecitabine and oxaliplatin together with bevacizumab works in treating patients who are undergoing surgery for liver metastases due to colorectal cancer.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Oxaliplatin, Capecitabine, and Bevacizumab Followed By Surgery and/or Radiofrequency Ablation in Patients With Colorectal Cancer

NCT00408772

Colorectal Cancer Metastatic Cancer

WITHDRAWN PHASE2

Capecitabine, Oxaliplatin, and Bevacizumab in Treating Patients With Metastatic or Recurrent Colorectal Cancer

NCT00416494

Colorectal Cancer

COMPLETED PHASE2

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

NCT00070265

Liver Metastases Recurrent Colon Cancer Recurrent Rectal Cancer +2 more

TERMINATED PHASE2

Study of Oxaliplatin, Capecitabine and Bevacizumab as First Line Treatment for Patients With Advanced Colorectal Cancer

NCT00159432

Colorectal Cancer

COMPLETED PHASE2

Capecitabine, Cetuximab, Oxaliplatin, and Bevacizumab in Treating Patients With Metastatic or Recurrent Colorectal Cancer That Cannot Be Removed By Surgery

NCT00290615

Colorectal Cancer

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colorectal Cancer Metastatic Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Chemotherapy + Surgery + Chemotherapy

Preoperative Neoadjuvant Chemotherapy

* Bevacizumab, 7.5 mg/kg, IV, Day 1 of cycles 1,2,3
* Oxaliplatin, 130 mg/m\^2, IV, Day 1 of cycles 1,2,3,4
* Capecitabine, 1,700 mg/m\^2/day divided, PO at 12 hr intervals, Days 1-14 of cycles 1,2,3,4

Conventional surgery: After 4 cycles of chemotherapy

Postoperative Neoadjuvant Chemotherapy

* Bevacizumab, 7.5 mg/kg, IV, Day 1 of cycles 1,2,3,4
* Oxaliplatin, 130 mg/m\^2, IV, Day 1 of cycles 1,2,3,4
* Capecitabine, 1,700 mg/m\^2/day divided, PO at 12 hr intervals, Days 1-14 of cycles 1,2,3,4

Group Type EXPERIMENTAL

bevacizumab

Intervention Type BIOLOGICAL

Preoperative: 7.5 mg/kg, IV, Day 1 of cycles 1,2,3 Postoperative: 7.5 mg/kg, IV, Day 1 of cycles 1,2,3,4

capecitabine

Intervention Type DRUG

Pre \& Post Operative: 1,700 mg/m\^2/day, PO at 12 hr interval, Days 1-14 of cycles 1,2,3,4

oxaliplatin

Intervention Type DRUG

130 mg/m\^2, IV, Day 1 of cycles 1,2,3,4

conventional surgery

Intervention Type PROCEDURE

Resection

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

bevacizumab

Preoperative: 7.5 mg/kg, IV, Day 1 of cycles 1,2,3 Postoperative: 7.5 mg/kg, IV, Day 1 of cycles 1,2,3,4

Intervention Type BIOLOGICAL

capecitabine

Pre \& Post Operative: 1,700 mg/m\^2/day, PO at 12 hr interval, Days 1-14 of cycles 1,2,3,4

Intervention Type DRUG

oxaliplatin

130 mg/m\^2, IV, Day 1 of cycles 1,2,3,4

Intervention Type DRUG

conventional surgery

Resection

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Avastin NSC-704865 Xeloda NSC-712807 NSC-266046

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jean-Nicolas Vauthey, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Robert de W. Marsh, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Cathy Eng, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Henry Q. Xiong, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Kevin G. Billingsley, MD

Role: PRINCIPAL_INVESTIGATOR

OHSU Knight Cancer Institute

Steven A. Curley, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, United States

Site Status

Rush-Copley Cancer Care Center

Aurora, Illinois, United States

Site Status

Joliet Oncology-Hematology Associates, Limited - West

Joliet, Illinois, United States

Site Status

Carle Cancer Center at Carle Foundation Hospital

Urbana, Illinois, United States

Site Status

CCOP - Carle Cancer Center

Urbana, Illinois, United States

Site Status

St. Francis Hospital and Health Centers - Beech Grove Campus

Beech Grove, Indiana, United States

Site Status

Saint Anthony Memorial Health Centers

Michigan City, Indiana, United States

Site Status

Reid Hospital & Health Care Services, Incorporated

Richmond, Indiana, United States

Site Status

Tammy Walker Cancer Center at Salina Regional Health Center

Salina, Kansas, United States

Site Status

Cancer Research Center at Boston Medical Center

Boston, Massachusetts, United States

Site Status

West Michigan Cancer Center

Kalamazoo, Michigan, United States

Site Status

Bronson Methodist Hospital

Kalamazoo, Michigan, United States

Site Status