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

• Status: Terminated
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eastern Cooperative Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cetuximab; Docetaxel; Fluorouracil; Oxaliplatin

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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