Cetuximab, Oxaliplatin, Fluorouracil, and Radiation Therapy in Treating Patients With Stage II or Stage III Esophageal Cancer

NCT00425425 | Unknown Phase 1

• 4 other identifiers: CDR0000516821KRDI-TUM-OE7-432-LOR-0033-IEU-20658EUDRACT-2006-001097-24
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 3

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. Cetuximab may also make tumor cells more sensitive to radiation therapy. Drugs used in chemotherapy, such as 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving cetuximab, chemotherapy, and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase I/II trial is studying the side effects and best dose of oxaliplatin and fluorouracil when given together with cetuximab and radiation therapy and to see how well they work in treating patients with stage II or stage III esophageal cancer.

Conditions

Esophageal Cancer

Keywords

squamous cell carcinoma of the esophagus; stage IIA esophageal cancer; stage IIB esophageal cancer; stage IIIA esophageal cancer; stage IIIB esophageal cancer; stage IIIC esophageal cancer

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose of oxaliplatin and fluorouracil (Phase I)

• Response rate (histological remission) (Phase II)

Secondary Outcomes (6)

• Toxicity as measured by NCI-CTC criteria

• Postoperative complication rate and lethality

• R0 resection rate

• Overall survival

• Event-free survival

Interventions

cetuximab BIOLOGICAL

fluorouracil DRUG

oxaliplatin DRUG

conventional surgery PROCEDURE

neoadjuvant therapy PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed squamous cell carcinoma of the esophagus, meeting the following criteria: * Locally advanced disease (T3-T4, N0-N+ \[T2, N0 for cervical esophageal carcinoma\]) * Potentially resectable disease * No distant metastases (M1b) * No tumor infiltration of the tracheobronchial system * Bartels preoperative risk analysis \< 22 PATIENT CHARACTERISTICS: * ECOG performance status (PS) 0-1 or Karnofsky PS 70-100% * Creatinine ≤ 1.5 mg/dL OR creatinine clearance \> 60 mL/min * Bilirubin ≤ 1.5 mg/dL * ALT and AST ≤ 2 times upper limit of normal (ULN) * Alkaline phosphatase ≤ 2 times ULN * WBC ≥ 3,000/mm³ * Granulocyte count ≥ 2,000/mm³ * Platelet count ≥ 100,000/mm³ * No pre-existing polyneuropathy \> grade 1 * No active uncontrolled infection * PaO\_2 ≥ 60 mm Hg on room air * FEV\_1 ≥ 60% of normal * No New York Heart Association class II-IV cardiac insufficiency * Ejection fraction ≥ 35% * No angina pectoris (at rest or under stress) unexplained by interventional cardiology * No myocardial infarction within the past 6 months * No histologically confirmed liver cirrhosis * No other malignancy within the past 5 years except carcinoma in situ of the cervix or nonmelanomatous skin cancer * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: * No prior chemotherapy * No prior radiotherapy to the thorax region * No current esophageal stent

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

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (3)

Charite University Hospital - Campus Virchow Klinikum

Berlin, D-13353, Germany

Location

Universitaetsklinikum Giessen und Marburg GmbH - Marburg

Marburg, D-35033, Germany

Location

Klinikum Rechts Der Isar - Technische Universitaet Muenchen

Munich, D-81675, Germany

Location

MeSH Terms

Conditions

Esophageal Neoplasms; Esophageal Squamous Cell Carcinoma

Interventions

Cetuximab; Fluorouracil; Oxaliplatin; Neoadjuvant Therapy; Radiotherapy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

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; Coordination Complexes; Organic Chemicals; Combined Modality Therapy; Therapeutics

Study Officials

• Florian Lordick, MD

  Technical University of Munich

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 19, 2007
• First Posted: January 23, 2007
• Study Start: July 1, 2006
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2015
• Last Updated: May 1, 2014

Record last verified: 2014-04

Locations

DE (3)