Bevacizumab and Combination Chemotherapy Before Surgery in Treating Patients With Locally Advance… (NCT01212822) | Clinical Trial Compass
CompletedPhase 2
Bevacizumab and Combination Chemotherapy Before Surgery in Treating Patients With Locally Advanced Esophageal or Stomach Cancer
United States20 participantsStarted 2011-04-27
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 writ…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.