Cetuximab and Combination Chemotherapy as First-Line Therapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver and/or Lung

NCT00557102 | Completed Phase 2

• 4 other identifiers: CDR0000574153CHUG-ERBIFORTINCA-RECF0316EUDRACT-2007-000357-54
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Monoclonal antibodies, such as 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. Drugs used in chemotherapy, such as irinotecan, leucovorin, 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 may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving cetuximab together with combination chemotherapy works as first-line therapy in treating patients with colorectal cancer that has spread to the liver and/or lung.

Conditions

Colorectal Cancer; Metastatic Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Tumor response rate

  From baseline to end of treatment

Secondary Outcomes (3)

• Rate of resectability

  From baseline to end of treatment

• Overall and disease-free survival

  From baseline to end of treatment

• Tolerability

  From baseline to end of treatment

Study Arms (1)

cetuximab, FOLFIRI

OTHER

Biological: cetuximab; Biological: filgrastim; Drug: fluorouracil; Drug: irinotecan hydrochloride; Drug: leucovorin calcium

Interventions

cetuximab BIOLOGICAL

cetuximab, FOLFIRI

filgrastim BIOLOGICAL

cetuximab, FOLFIRI

fluorouracil DRUG

cetuximab, FOLFIRI

irinotecan hydrochloride DRUG

cetuximab, FOLFIRI

leucovorin calcium DRUG

cetuximab, FOLFIRI

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the colon or rectum * Must have synchronous or metasynchronous unresectable hepatic metastases * Less than 8 hepatic metastases * Less than 6 segments of liver involvement with metastases * No more than 2 potentially resectable extrahepatic (e.g., pulmonary) metastases * Patients with visceral metastases that are potentially resectable after chemotherapy (i.e., tumor regression) are eligible * At least 1 measurable metastasis by CT scan or MRI * No brain metastases, bone metastases, or carcinomatous meningitis * No celiac lymph node involvement or peritoneal cancer PATIENT CHARACTERISTICS: * WHO performance status 0-1 * Life expectancy \> 3 months * ANC ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * PT rate \> 70% * Bilirubin \< 30 μmol/L * Creatinine \< 130 μmol/L * Creatinine clearance \> 60 mL/min * Not pregnant or nursing * No other prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix * No severe unstable angina * No symptomatic heart failure * No other concurrent illness PRIOR CONCURRENT THERAPY: * At least 3 months since prior adjuvant anticancer chemotherapy * No concurrent participation in another clinical trial

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

Sponsors & Collaborators

• National Cancer Institute, France: lead
• University Hospital, Grenoble: collaborator

Study Sites (1)

CHU de Grenoble - Hopital Michallon

Grenoble, 38043, France

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis; Rectal Neoplasms; Colonic Neoplasms

Interventions

Cetuximab; Filgrastim; Fluorouracil; Irinotecan; Leucovorin

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; Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Biological Factors; 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

Study Officials

• Jean Marc Phelip, MD, PhD

  University Hospital, Grenoble

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: November 9, 2007
• First Posted: November 12, 2007
• Study Start: September 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: December 11, 2012

Record last verified: 2012-12

Locations

FR (1)