Cetuximab, Leucovorin, Oxaliplatin, and Fluorouracil With or Without Bevacizumab in Treating Patients With Resectable Liver Metastases From Colorectal Cancer

NCT00438737 | Unknown Phase 2

• 4 other identifiers: CDR0000530116EORTC-40051EUDRACT-2005-002825-29EU-20776
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Monoclonal antibodies, such as cetuximab and 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.Drugs used in chemotherapy, such as leucovorin, oxaliplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving cetuximab together with combination chemotherapy and bevacizumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery. PURPOSE: This randomized phase II trial is studying the side effects and how well giving cetuximab together with leucovorin, oxaliplatin, and fluorouracil works with or without bevacizumab in treating patients with resectable liver metastases from colorectal cancer.

Conditions

Colorectal Cancer; Metastatic Cancer

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Response rate (preoperative response rate)

• Safety (rate of perioperative safety findings)

Secondary Outcomes (3)

• Progression-free survival

• Pathological resection rate

• Overall survival

Interventions

bevacizumab BIOLOGICAL

cetuximab BIOLOGICAL

fluorouracil DRUG

leucovorin calcium DRUG

oxaliplatin DRUG

adjuvant therapy PROCEDURE

conventional surgery PROCEDURE

neoadjuvant therapy PROCEDURE

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Diagnosis of metastatic colorectal cancer, meeting all of the following criteria: * Metachronous or synchronous liver metastases * Metastases potentially completely resectable * No requirement for resection combined with cryotherapy or radiofrequency ablation * Must have undergone complete resection (R0) of the primary tumor within the past 4 weeks * Measurable liver metastases * No evidence of extrahepatic disease * 1 or 2 resectable lung metastases allowed PATIENT CHARACTERISTICS: * WHO performance status 0-1 * Absolute neutrophil count \> 1,500/mm³ * Platelet count \> 100,000/mm³ * Hemoglobin \> 9 g/dL * WBC \> 3,000/mm³ * Creatinine \< 1.5 times upper limit of normal (ULN) * Bilirubin \< 1.5 times ULN * AST and ALT \< 5 times ULN * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No significant proteinuria (i.e., protein \> 500 mg/24-hour urine collection) * No known allergy to any of the study drugs (including excipients) or any related compound, including hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies * No bleeding diathesis or coagulopathy * No peripheral neuropathy \> grade 1 * No serious nonhealing wound, ulcer, or bone fracture * No clinically significant cardiovascular disease, including any of the following: * Uncontrolled hypertension * New York Heart Association class II-IV congestive heart failure * Unstable angina pectoris within the past 12 months * Peripheral vascular disease ≥ grade 2 * Serious cardiac arrhythmia requiring medication * Myocardial infarction within the past 12 months * Cerebrovascular accident or transient ischemic attack within the past 12 months * No symptomatic diverticulitis or known gastroduodenal ulceration * No significant traumatic injury within the past 4 weeks * No known alcohol or drug abuse * No psychological, familial, social, or geographical condition that would preclude study compliance * No other significant disease that would preclude study participation PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior chemotherapy for metastatic disease * At least 1 month since prior major surgical procedure or open biopsy * More than 30 days since prior participation in another clinical study * Prior adjuvant chemotherapy for primary cancer allowed provided the following criteria are met: * At least 12 months since prior oxaliplatin-containing adjuvant therapy * No persistent neuropathy * No prior therapy targeting the epidermal growth factor receptor or vascular endothelial growth factor (VEGF)/VEGF receptor * No concurrent regular use of acetylsalicylic acid (\> 325 mg/day) or other nonsteroidal anti-inflammatory drugs * No concurrent full-dose anticoagulation * No concurrent prophylactic hematopoietic growth factors * No concurrent allopurinol

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

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (1)

Hopital Ambroise Pare

Boulogne, F-92104, France

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis; Colonic Neoplasms; Rectal Neoplasms

Interventions

Bevacizumab; Cetuximab; Fluorouracil; Leucovorin; Oxaliplatin; Chemotherapy, Adjuvant; Neoadjuvant Therapy

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; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Coordination Complexes; Organic Chemicals; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Bernard Nordlinger, MD

  Hopital Ambroise Pare

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: February 20, 2007
• First Posted: February 22, 2007
• Study Start: January 1, 2007
• Last Updated: September 2, 2011

Record last verified: 2007-09

Locations

FR (1)