Clinical Trials Directory

Trials / Completed

CompletedNCT01212822

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

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

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
20 (actual)
Sponsor
Fox Chase Cancer Center · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
BIOLOGICALbevacizumabGiven IV
DRUGoxaliplatinGiven IV
DRUGleucovorin calciumGiven IV
DRUGfluorouracilGiven IV
PROCEDUREtherapeutic conventional surgeryUndergo surgical resection
OTHERlaboratory biomarker analysisCorrelative studies

Timeline

Start date
2011-04-27
Primary completion
2014-10-24
Completion
2018-01-03
First posted
2010-10-01
Last updated
2022-09-07
Results posted
2022-09-07

Locations

3 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT01212822. Inclusion in this directory is not an endorsement.