Phase 2
N=20
Bevacizumab and Combination Chemotherapy Before Surgery in Treating Patients With Locally Advanced Esophageal or Stomach Cancer
Adenocarcinoma of the Esophagus · Adenocarcinoma of the Gastroesophageal Junction · Diffuse Adenocarcinoma of the Stomach · Intestinal Adenocarcinoma of the Stomach · Mixed Adenocarcinoma of the Stomach
Bottom Line
View on ClinicalTrials.gov: NCT01212822 ↗Enrolled (actual)
20
Serious AEs
55.0%
Results posted
Sep 2022
Primary outcome: Primary: Disease-free Survival — 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- bevacizumab (Biological); oxaliplatin (Drug); leucovorin calcium (Drug); fluorouracil (Drug); therapeutic conventional surgery (Procedure); laboratory biomarker analysis (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Fox Chase Cancer Center
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Disease-free Survival |
4 | — |
| SECONDARY Complete and Partial Response to Neoadjuvant Therapy Based on the Response Evaluation Criteria in Solid Tumors (RECIST) |
44.4 | — |
| SECONDARY Overall Survival |
26.0 | — |
| SECONDARY Progression Free Survival |
19.0 | — |
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 Criteria
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) = = 60 cc/min
- Bilirubin must be = 1.0 or dipstick of 2+ must undergo a 24-hour urine collection and must demonstrate = grade 2 neuropathy are not eligible
- Patients must not have had significant traumatic injury within 28 days prior to randomization
- Patients with PT (INR) > 1.5 are not eligible; the patient may not be receiving full-dose anticoagulation; prophylactic or full dose anticoagulation are permitted post-resection or for treatment of an intercurrent thrombotic event
- Patients with non-malignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude any of the study therapy drugs are not eligible; specifically excluded are the following conditions: current symptomatic arrhythmia, symptomatic peripheral vascular disease
- Patients with a history of the following within 12 months of study entry are not eligible: arterial thromboembolic events, unstable angina
- Any history of stroke or transient ischemic attack
- Significant vascular disease (i.e. aortic dissection, aortic aneurysm)
- Patients with psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude them from meeting the study requirements are not eligible
- Distant metastases
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment
- Known hypersensitivity to any component of bevacizumab
Data sourced from ClinicalTrials.gov (NCT01212822). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.