Status:
COMPLETED
FOLFOX With Bevacizumab in Metastatic or Unresectable Gastroesophageal and Gastric Cancer
Lead Sponsor:
Yale University
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Gastroesophageal Cancer
Gastric Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a Phase II open-label study to determine the anti-tumor efficacy and tolerability of FOLFOX in combination with bevacizumab (Avastin(TM))in patients with metastatic or unresectable gastroesoph...
Eligibility Criteria
Inclusion
- Histologically or cytologically documented recurrent, metastatic or unresectable gastroesophageal (Siewert type I, II, III) or gastric adenocarcinoma with measurable or assessable non-measurable disease (RECIST criteria).
- If recurrent or metastatic disease is not histologically confirmed, then documentation by a second radiographic procedure (i.e., PET scan or MRI in addition to CT scan) is required. If the imaging procedure does not confirm recurrent or metastatic disease, biopsy confirmation is required
- 12 months since completion of any prior neoadjuvant or adjuvant therapy (chemotherapy or radiotherapy) for potentially resectable gastroesophageal or gastric adenocarcinoma.
- \>4 weeks since major surgery.
- ECOG Performance Status: 0-1
- Life expectancy \>12 weeks
- Laboratory parameters as follows: absolute neutrophil count ≥1,500/uL, platelet count ≥100,000/uL, hemoglobin ≥9 g,/dL, creatinine \<1.5 X ULN or estimated GFR \>30 ml's/min, urinalysis \<2+ protein, baseline proteinuria \<1000 mg/d or urine protein/creatinine ratio \<1, bilirubin \<2 X ULN, PT (INR) \<1.5 if patient not on anticoagulation, negative pregnancy test in women of childbearing age
- Hypertension must be well controlled (\<160/90)
- Paraffin block or slides must be available
- Patients on full-dose anticoagulants must be on a stable dose of warfarin and have an in-range INR or be on a stable dose of low molecular weight heparin.
Exclusion
- prior treatment for recurrent, metastatic, or unresectable gastroesophageal or gastric adenocarcinoma
- other concurrent anticancer therapy
- other malignancy within past three years except basal cell carcinoma of the skin, cervical carcinoma in situ, or nonmetastatic prostate cancer known central nervous system metastases or carcinomatous meningitis.
- interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung.
- \> grade 2 sensory peripheral neuropathy.
- uncontrolled seizure disorder, active neurological disease, or known CNS disease.
- significant cardiac disease, including the following: unstable angina, New York Heart Association class II-IV congestive heart failure, myocardial infarction within six months prior to study enrollment.
- history of hypertensive crisis or hypertensive encephalopathy
- abdominal fistula, gastrointestinal bleeding, or intra-abdominal abscess within the 6 months prior to study enrollment.
- core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to study enrollment.
- major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of need for major surgical procedure during the course of the study.
- recent arterial thrombotic events including stroke or TIA within 6 months prior to study enrollment.
- serious or non-healing wound, ulcer or bone fracture.
- active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices).
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00673673
Start Date
May 1 2008
End Date
July 1 2014
Last Update
February 4 2015
Active Locations (2)
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1
Medical Oncology & Hematology PC
Hamden, Connecticut, United States
2
Yale University School of Medicine
New Haven, Connecticut, United States, 06520