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

Status: Completed
Location: See all (3) locations...
Intervention Type: Procedure, Drug, Other, Biological
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients must have biopsy proven adenocarcinoma, squamous cell carcinoma or undifferentiated carcinoma of the esophagus, GE junction and/or gastric cardia

• Patients must have potentially resectable disease by the thoracic, minimally invasive or transhiatal approach

‣ No portion of the lesion may be within 5 cm of the cricopharyngeus

⁃ Patient must be considered medically fit for surgery with average or below average risk

⁃ T1-3 or T4 with local invasion confined to diaphragm, pleura or pericardium

⁃ No myocardial infarction within 12 months of enrollment

• Patients must have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

• White blood cells (WBC) \>= 3,500/mm\^3

• Platelet count \>= 100,000/mm\^3

• Serum creatinine (Cr) =\< 1.5 mg and/or creatinine clearance \>= 60 cc/min

• Bilirubin must be \< upper limit of normal (ULN) unless the patient has a chronic grade 1 bilirubin elevation due to Gilbert's disease or similar syndrome due to slow conjugation of bilirubin

• Alkaline phosphatase must be \< ULN

• Aspartate aminotransferase (AST) \& alanine aminotransferase (ALT) must be \< ULN

• Urine protein/creatinine (UPC) ratio of \< 1.0 or dipstick for protein of \< 2+, Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v 4) grade \< 2; patients with a UPC ratio \>= 1.0 or dipstick of 2+ must undergo a 24-hour urine collection and must demonstrate \< 1 gm of protein in order to participate

• Patients must give written informed consent and Health Insurance Portability and Accountability Act (HIPAA) consent

Locations
United States
Ohio
Case Western Reserve University
Cleveland
Pennsylvania
Fox Chase Cancer Center
Philadelphia
University of Pittsburgh Cancer Institute
Pittsburgh
Time Frame
Start Date: 2011-04-27
Completion Date: 2018-01-03
Participants
Target number of participants: 20
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Fox Chase Cancer Center
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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