Chemotherapy, Radiation Therapy, and Cetuximab Followed by Surgery, Docetaxel, and Cetuximab in Treating Patients With Esophageal Cancer or Gastroesophageal Junction Cancer

Stopped early · Phase 2

Conditions studied: Esophageal Cancer

In brief

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, and docetaxel, 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. 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. Giving these treatments before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving docetaxel and cetuximab after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well giving chemotherapy and radiation therapy together with cetuximab followed by surgery, docetaxel and cetuximab works in treating patients with esophageal cancer or gastroesophageal junction cancer.

Key facts

Study ID

NCT00551759

Run by

Eastern Cooperative Oncology Group

People needed

22

Starts

2008-10-02

Expected to finish

2014-02-01

Last updated by the study team

2023-07-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Newly diagnosed adenocarcinoma of the esophagus (> 20 cm below the incisors) or gastroesophageal (GE) junction, untreated with chemotherapy, radiation therapy, and surgery. Endoscopy with biopsy and dilation was permitted.
• Tumor stage T2N0M0, T3N0M0, T1-3N+M0, or T1-3N0-1M1A as determined by imaging studies performed no greater than 4 weeks prior to registration, and biopsy, where appropriate. Celiac nodal metastasis (M1A disease) was permitted if other eligibility criteria were met. Data from endoscopic ultrasound and endoscopy were required for staging. The following imaging was required: CT scan with IV contrast and PET or PET+CT. If the PET/CT incorporates CT with IV contrast, then a separate CT is not required. If laparoscopy or other relevant procedures were performed, the data were to be incorporated into stage assignment. Any lesion suspicious for metastasis had to have been biopsied to prove eligibility.
• Tumor extension into cardia, if present, must have been no more than 2 cm.
• Tumors must have been considered surgically resectable (T1-3, not T4).
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Granulocytes > 1,000/ mm³
• Platelets > 100,000 μL
• Creatinine normal or creatinine clearance > 60 mL/min
• Total serum bilirubin < 1.5 mg/dL
• Fertile patients must use effective contraception
• History of a curatively treated malignancy from which the patient has been disease-free for ≥ 2 years and has a survival prognosis of > 5 years

You may not qualify if…

• Pregnant or breast-feeding.
• Prior severe infusion reaction to a monoclonal antibody
• prior therapy specifically and directly targeting the epidermal growth factor receptor (EGFR) pathway
• Hypertension
• Uncontrolled diabetes
• Intercurrent illness that would likely interfere with protocol therapy or prevent surgical resection
• Any of the following within the past 6 months:
• New York Heart Association class III-IV congestive heart failure
• Cerebrovascular accident or transient ischemic attack
• Unstable angina or myocardial infarction

Where it is running

• CCOP - Christiana Care Health Services — Newark, Delaware, United States
• Rush-Copley Cancer Care Center — Aurora, Illinois, United States
• Robert H. Lurie Comprehensive Cancer Center at Northwestern University — Chicago, Illinois, United States
• Hematology and Oncology Associates — Chicago, Illinois, United States
• Decatur Memorial Hospital Cancer Care Institute — Decatur, Illinois, United States
• Hinsdale Hematology Oncology Associates — Hinsdale, Illinois, United States
• Midwest Center for Hematology/Oncology — Joliet, Illinois, United States
• Joliet Oncology-Hematology Associates, Limited - West — Joliet, Illinois, United States
• North Shore Oncology and Hematology Associates, Limited - Libertyville — Libertyville, Illinois, United States
• La Grange Oncology Associates - Geneva — Naperville, Illinois, United States
• Cancer Care and Hematology Specialists of Chicagoland - Niles — Niles, Illinois, United States
• Swedish-American Regional Cancer Center — Rockford, Illinois, United States
• Hematology Oncology Associates - Skokie — Skokie, Illinois, United States
• Regional Cancer Center at Memorial Medical Center — Springfield, Illinois, United States
• Carle Cancer Center at Carle Foundation Hospital — Urbana, Illinois, United States
• CCOP - Carle Cancer Center — Urbana, Illinois, United States
• Saint Anthony Memorial Health Centers — Michigan City, Indiana, United States
• McFarland Clinic, PC — Ames, Iowa, United States
• Cedar Rapids Oncology Associates — Cedar Rapids, Iowa, United States
• Mercy Capitol Hospital — Des Moines, Iowa, United States
• CCOP - Iowa Oncology Research Association — Des Moines, Iowa, United States
• John Stoddard Cancer Center at Iowa Methodist Medical Center — Des Moines, Iowa, United States
• Medical Oncology and Hematology Associates at John Stoddard Cancer Center — Des Moines, Iowa, United States
• Medical Oncology and Hematology Associates at Mercy Cancer Center — Des Moines, Iowa, United States
• Tunnell Cancer Center at Beebe Medical Center — Lewes, Delaware, United States

Full record on ClinicalTrials.gov

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