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

NCT00118105 | Withdrawn Phase 2 DMC

• 3 other identifiers: CDR0000433491S0408U10CA032102
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 46

Brief Summary

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.

Conditions

Colorectal Cancer; Metastatic Cancer

Keywords

recurrent colon cancer; stage IV colon cancer; recurrent rectal cancer; stage IV rectal cancer; liver metastases

Outcome Measures

Primary Outcomes (7)

• Proportion of patients with R0 resection after treatment

  16-18 weeks from registration

• Probability of nonprogression (i.e., stable disease or response [complete and partial, confirmed and unconfirmed])

  12 weeks from registration

• Comparison of patients achieving R0 resection with literature

  16-18 weeks from registration

• Overall survival

  Up to 3 years

• Disease-free survival

  Up to 3 years

• Positron emission tomography response

  Registration and 12 weeks

• Correlation of clinical outcome with expression of biomarkers and telomere length

  Up to 3 years

Study Arms (1)

Chemotherapy + Surgery + Chemotherapy

EXPERIMENTAL

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

Biological: bevacizumab; Drug: capecitabine; Drug: oxaliplatin; Procedure: conventional surgery

Interventions

bevacizumab 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

Also known as: Avastin, NSC-704865

Chemotherapy + Surgery + Chemotherapy

capecitabine DRUG

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

Also known as: Xeloda, NSC-712807

Chemotherapy + Surgery + Chemotherapy

oxaliplatin DRUG

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

Also known as: NSC-266046

Chemotherapy + Surgery + Chemotherapy

conventional surgery PROCEDURE

Resection

Chemotherapy + Surgery + Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• SWOG Cancer Research Network: lead
• National Cancer Institute (NCI): collaborator
• Eastern Cooperative Oncology Group: collaborator

Study Sites (46)

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90089-9181, United States

Location

Rush-Copley Cancer Care Center

Aurora, Illinois, 60507, United States

Location

Joliet Oncology-Hematology Associates, Limited - West

Joliet, Illinois, 60435, United States

Location

Carle Cancer Center at Carle Foundation Hospital

Urbana, Illinois, 61801, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

St. Francis Hospital and Health Centers - Beech Grove Campus

Beech Grove, Indiana, 46107, United States

Location

Saint Anthony Memorial Health Centers

Michigan City, Indiana, 46360, United States

Location

Reid Hospital & Health Care Services, Incorporated

Richmond, Indiana, 47374, United States

Location

Tammy Walker Cancer Center at Salina Regional Health Center

Salina, Kansas, 67401, United States

Location

Cancer Research Center at Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

West Michigan Cancer Center

Kalamazoo, Michigan, 49007-3731, United States

Location

Bronson Methodist Hospital

Kalamazoo, Michigan, 49007, United States

Location

Borgess Medical Center

Kalamazooaa, Michigan, 49001, United States

Location

CCOP - Montana Cancer Consortium

Billings, Montana, 59101, United States

Location

Hematology-Oncology Centers of the Northern Rockies - Billings

Billings, Montana, 59101, United States

Location

Northern Rockies Radiation Oncology Center

Billings, Montana, 59101, United States

Location

St. Vincent Healthcare

Billings, Montana, 59101, United States

Location

Billings Clinic Cancer Center

Billings, Montana, 59107-5100, United States

Location

Deaconess Billings Clinic - Downtown

Billings, Montana, 59107-7000, United States

Location

Bozeman Deaconess Cancer Center

Bozeman, Montana, 59715, United States

Location

St. James Community Hospital

Butte, Montana, 59701, United States

Location

Frontier Cancer Center

Great Falls, Montana, 59405, United States

Location

Great Falls Clinic

Great Falls, Montana, 59405, United States

Location

St. Peter's Hospital

Helena, Montana, 59601, United States

Location

Glacier Oncology, PLLC

Kalispell, Montana, 59901, United States

Location

Kalispell Medical Oncology

Kalispell, Montana, 59901, United States

Location

Kalispell Regional Medical Center

Kalispell, Montana, 59901, United States

Location

Community Medical Center

Missoula, Montana, 59801, United States

Location

Guardian Oncology and Center for Wellness

Missoula, Montana, 59804, United States

Location

Montana Cancer Specialists at Montana Cancer Center

Missoula, Montana, 59807-7877, United States

Location

Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

Missoula, Montana, 59807, United States

Location

Wayne Memorial Hospital, Incorporated

Goldsboro, North Carolina, 27534, United States

Location

Grandview Hospital

Dayton, Ohio, 45405, United States

Location

Good Samaritan Hospital

Dayton, Ohio, 45406, United States

Location

David L. Rike Cancer Center at Miami Valley Hospital

Dayton, Ohio, 45409, United States

Location

Samaritan North Cancer Care Center

Dayton, Ohio, 45415, United States

Location

Veterans Affairs Medical Center - Dayton

Dayton, Ohio, 45428, United States

Location

CCOP - Dayton

Dayton, Ohio, 45429, United States

Location

Blanchard Valley Medical Associates

Findlay, Ohio, 45840, United States

Location

Charles F. Kettering Memorial Hospital

Kettering, Ohio, 45429, United States

Location

St. Rita's Medical Center

Lima, Ohio, 45801, United States

Location

Middletown Regional Hospital

Middletown, Ohio, 45044, United States

Location

UVMC Cancer Care Center at Upper Valley Medical Center

Troy, Ohio, 45373-1300, United States

Location

Ruth G. McMillan Cancer Center at Greene Memorial Hospital

Xenia, Ohio, 45385, United States

Location

Danville Regional Medical Center

Danville, Virginia, 24541, United States

Location

Welch Cancer Center at Sheridan Memorial Hospital

Sheridan, Wyoming, 82801, United States

Location

Related Publications (1)

• Abdalla EK, Eng C, Madary A, Vauthey JN; Southwest Oncology Group 0408. Southwest Oncology Group 0408: Phase II trial of neoadjuvant capecitabine/oxaliplatin/bevacizumab for resectable colorectal metastases in the liver. Clin Colorectal Cancer. 2006 Mar;5(6):436-9. doi: 10.3816/ccc.2006.n.015. No abstract available.

  PMID: 16635283 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis; Colonic Neoplasms; Rectal Neoplasms

Interventions

Bevacizumab; Capecitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals

Study Officials

• Jean-Nicolas Vauthey, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

• Robert de W. Marsh, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

• Cathy Eng, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

• Henry Q. Xiong, MD, PhD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

• Kevin G. Billingsley, MD

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

• Steven A. Curley, MD

  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: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2005
• First Posted: July 11, 2005
• Study Start: November 1, 2006
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: January 3, 2013

Record last verified: 2013-01

Locations

US (46)