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

Conditions

• Adenocarcinoma of the Esophagus
• Adenocarcinoma of the Gastroesophageal Junction
• Diffuse Adenocarcinoma of the Stomach
• 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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• bevacizumab — BIOLOGICAL
  Given IV
• oxaliplatin — DRUG
  Given IV
• leucovorin calcium — DRUG
  Given IV
• fluorouracil — DRUG
  Given IV
• therapeutic conventional surgery — PROCEDURE
  Undergo surgical resection
• laboratory biomarker analysis — OTHER
  Correlative studies

Study Details

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.

Key Dates

First listed

Oct 1, 2010

Start date

Apr 27, 2011

Status verified

Aug 2022

Primary completion

Oct 24, 2014

Completion

Jan 3, 2018

Study Design

Enrollment

20 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (bevacizumab, FOLFOX)
  NEOADJUVANT THERAPY: Patients receive bevacizumab 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.

Primary Outcome Measure

Disease-free Survival [ Time Frame: 2 years ]

Locations (3)

Find similar trials in Cleveland, OH

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