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

NCT00408772 | Withdrawn Phase 2 DMC

• 3 other identifiers: 200412546UCDCC#131CDR0000517440
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, 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. Radiofrequency ablation uses a high-frequency, electric current to kill tumor cells. Giving chemotherapy and bevacizumab before surgery or radiofrequency ablation may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase II trial is studying how well giving oxaliplatin and capecitabine together with bevacizumab followed by surgery and/or radiofrequency ablation works in treating patients with colorectal cancer that has spread to the liver and cannot be removed by surgery.

Conditions

Colorectal Cancer; Metastatic Cancer

Keywords

liver metastases; stage IV colon cancer; stage IV rectal cancer; adenocarcinoma of the colon; adenocarcinoma of the rectum; recurrent colon cancer; recurrent rectal cancer

Outcome Measures

Primary Outcomes (1)

• Conversion rate of nonresectable disease to resectable disease

  48 months

Secondary Outcomes (3)

• Disease-free and overall survival

  48 months

• Objective response rate

  48 months

• Duration of response

  48 months

Study Arms (1)

Unresectable colorectal liver mets

EXPERIMENTAL

Biological: bevacizumab; Drug: capecitabine; Drug: oxaliplatin; Procedure: conventional surgery; Procedure: neoadjuvant therapy; Procedure: radiofrequency ablation

Interventions

bevacizumab BIOLOGICAL

Unresectable colorectal liver mets

capecitabine DRUG

Unresectable colorectal liver mets

oxaliplatin DRUG

Unresectable colorectal liver mets

conventional surgery PROCEDURE

Unresectable colorectal liver mets

neoadjuvant therapy PROCEDURE

Unresectable colorectal liver mets

radiofrequency ablation PROCEDURE

Unresectable colorectal liver mets

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed colorectal adenocarcinoma metastatic to the liver * Unresectable liver metastases * Measurable disease * No evidence of extrahepatic metastases * No CNS metastases PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Absolute neutrophil count \> 1,500/mm\^3 * Platelet count \> 100,000/mm\^3 * Creatinine ≤ 1.5 times upper limit of normal (ULN) OR creatinine clearance ≥ 45 mL/min * Urinary protein \< 2+ by dipstick OR \< 2 g by 24-hour urine collection * Bilirubin \< 2 times ULN * SGOT and SGPT \< 2 times ULN * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 18 months after completion of study therapy * Able to take oral medications (e.g., no dysphagia or malabsorption symptoms) * No other prior malignancy unless in complete remission and off therapy for ≥ 5 years * No known allergy to the study drugs * No peripheral neuropathy \> grade 1 * No uncontrolled infection * No uncontrolled hypertension * No active bleeding or hemoptysis * No other serious concurrent illness within the past 12 months, including any of the following: * Nonstable coronary artery disease * Myocardial infarction * Transient ischemic attack * Cardiovascular accident PRIOR CONCURRENT THERAPY: * Recovered from prior therapy * At least 28 days since prior major surgery * Prior therapy for advanced disease allowed * No prior oxaliplatin-based therapy * Concurrent maintenance and palliative treatment during study chemotherapy allowed (e.g., nutritional or transfusional support or pain control) * No concurrent corticosteroids except when used under the following circumstances: * As oxaliplatin premedication * Anti-5-HT\_3 as antiemetic * No concurrent cold cap or iced mouth rinses * No other concurrent chemotherapy * No placement of hepatic artery port for regional chemotherapy

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

Sponsors & Collaborators

• University of California, Davis: lead
• Sanofi: collaborator

Study Sites (1)

University of California Davis Cancer Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis; Colonic Neoplasms; Rectal Neoplasms

Interventions

Bevacizumab; Capecitabine; Oxaliplatin; Neoadjuvant Therapy; Radiofrequency Ablation

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; Combined Modality Therapy; Therapeutics; Radiofrequency Therapy; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Vijay Khatri, MD, FACS

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2006
• First Posted: December 7, 2006
• Study Start: June 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: June 9, 2017

Record last verified: 2017-06

Locations

US (1)