Bevacizumab and Combination Chemotherapy Before Surgery in Treating Patients With Locally Advanced Esophageal or Stomach Cancer

Adenocarcinoma of the Gastroesophageal Junction Clinical Trial

Official title: Phase II Trial of Pre-operative Bevacizumab and FOLFOX Chemotherapy in Locally Advanced Esophageal Cancer

Status Completed

Clinical Trial Summary

This pilot phase II trial studies how well giving bevacizumab and combination chemotherapy together before surgery works in treating patients with locally advanced esophageal or stomach cancer. Monoclonal antibodies, such as bevacizumab, 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 leucovorin calcium, fluorouracil, and oxaliplatin work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab and combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To investigate two-year disease-free survival in patients with resectable esophageal and gastroesophageal (GE) junction cancer treated with perioperative bevacizumab and leucovorin calcium, fluorouracil, and oxaliplatin (FOLFOX).

SECONDARY OBJECTIVES:

I. To assess, by pathological examination after surgical resection, complete and partial response to neoadjuvant therapy.

II. To characterize overall and progression free survival. III. To compare baseline and post-chemotherapy/bevacizumab tissues for biomarkers predicting response or resistance to this approach.

IV. To investigate safety in this setting.

OUTLINE:

NEOADJUVANT THERAPY: Patients receive bevacizumab intravenously (IV) over 30-90 minutes on day 1. Patients also receive FOLFOX chemotherapy comprising oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 46 hours on days 1-2. Treatment with bevacizumab repeats every 2 weeks for 4 courses and treatment with FOLFOX repeats every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.

SURGERY: Patients then undergo planned surgical resection 4-6 weeks after 6 courses of chemotherapy and at least 8 weeks since the last dose of bevacizumab.

ADJUVANT THERAPY: Beginning 8-10 weeks after surgery, patients receive bevacizumab IV, oxaliplatin IV, leucovorin calcium IV, and fluorouracil IV as in neoadjuvant therapy. Treatment repeats every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter. ;

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Esophagus
• Adenocarcinoma of the Gastroesophageal Junction
• Diffuse Adenocarcinoma of the Stomach
• Esophageal Neoplasms
• Esophageal Squamous Cell Carcinoma
• Intestinal Adenocarcinoma of the Stomach
• Mixed Adenocarcinoma of the Stomach
• Squamous Cell Carcinoma of the Esophagus
• Stage IA Esophageal Cancer
• Stage IA Gastric Cancer
• Stage IB Esophageal Cancer
• Stage IB Gastric Cancer
• Stage IIA Esophageal Cancer
• Stage IIA Gastric Cancer
• Stage IIB Esophageal Cancer
• Stage IIB Gastric Cancer
• Stage IIIA Esophageal Cancer
• Stage IIIA Gastric Cancer
• Stage IIIB Esophageal Cancer
• Stage IIIB Gastric Cancer
• Stage IIIC Esophageal Cancer
• Stage IIIC Gastric Cancer
• Stomach Neoplasms

• NCT number: NCT01212822
• Study type: Interventional
• Source: Fox Chase Cancer Center
• Status: Completed
• Phase: Phase 2
• Start date: April 27, 2011
• Completion date: January 3, 2018