Combination Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With Advanced Colorectal Cancer With Liver Metastases or Lung Metastases That Are Potentially Removable by Surgery

NCT00513266 | Unknown Phase 2

• 3 other identifiers: CDR0000559146CHUV-CH-OCFL-BCEU-20741
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 4

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, irinotecan, fluorouracil and leucovorin, 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 and cetuximab, 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. Giving combination chemotherapy together with monoclonal antibody therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with monoclonal antibody therapy works in treating patients with advanced colorectal cancer with liver metastases or lung metastases that are potentially removable by surgery.

Conditions

Colorectal Cancer; Metastatic Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Pathological complete response rate of lesions of less than or equal to 30 mm in size assessed by pathologic examination in resected specimens

Secondary Outcomes (2)

• Response as assessed by NCIC criteria

• Toxicity as assessed by NCIC criteria

Interventions

bevacizumab BIOLOGICAL

cetuximab BIOLOGICAL

fluorouracil DRUG

irinotecan hydrochloride DRUG

leucovorin calcium DRUG

oxaliplatin DRUG

laboratory biomarker analysis OTHER

adjuvant therapy PROCEDURE

biopsy PROCEDURE

conventional surgery PROCEDURE

neoadjuvant therapy PROCEDURE

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed metastatic colorectal adenocarcinoma
• Bidimensionally measurable metastatic disease limited to the liver and considered curatively resectable after response to systemic therapy as assessed by a surgical board
• Additional metastatic disease to the lungs consisting of no more than 3 potentially resectable lesions allowed
• Must have at least one lesion of 30 mm or less

You may not qualify if:

• History or evidence upon physical examination of CNS disease unless adequately treated (e.g., uncontrolled seizure with standard medical therapy or history of stroke)
• PATIENT CHARACTERISTICS:
• Performance status ≤ 1
• Life expectancy \> 12 weeks
• WBC ≥ 3,000/mm\^3
• Platelet count ≥ 100,000/mm\^3
• Creatinine 1.25 x upper limit of normal (ULN)
• Bilirubin 1.25 x ULN (1.5 x ULN if liver metastasis)
• AST and ALT ≤ 3 x ULN (≤ 5 x ULN if liver metastasis)
• Woman and men of childbearing age must use adequate contraception
• Pregnancy (positive serum pregnancy test) or lactation
• Chronic diarrhea ≥ grade 2
• Other serious illness or medical condition including any of the following:
• Unstable cardiac disease requiring treatment
• Congestive heart failure or angina pectoris even if medically controlled

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead

Study Sites (4)

Kantonspital Aarau

Chur, CH-7000, Switzerland

Location

Hopital Cantonal Universitaire de Geneve

Geneva, CH-1211, Switzerland

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, CH-1011, Switzerland

Location

Hopital Regional de Sion-Herens-Conthey

Sion, CH -1951, Switzerland

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis; Rectal Neoplasms; Colonic Neoplasms

Interventions

Bevacizumab; Cetuximab; Fluorouracil; Irinotecan; Leucovorin; Oxaliplatin; Chemotherapy, Adjuvant; Biopsy; 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; Camptothecin; Alkaloids; 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; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Arnaud Roth, MD

  Hopital Cantonal Universitaire de Geneve

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 6, 2007
• First Posted: August 8, 2007
• Study Start: June 1, 2007
• Last Updated: August 7, 2009

Record last verified: 2009-06

Locations

CH (4)