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Phase II Study of FOLFOX With Bevacizumab (Avastin(TM)) in Metastatic or Unresectable Gastroesophageal and Gastric Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Gastroesophageal Cancer, Gastric Cancer

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Trial Information

Phase II Study of FOLFOX With Bevacizumab (Avastin(TM)) in Metastatic or Unresectable Gastroesophageal and Gastric Cancer


Inclusion Criteria:



- 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 Criteria:

- 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).

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to Progression (TTP)

Outcome Time Frame:

Upon completion of study

Safety Issue:

No

Principal Investigator

Jill Lacy, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Yale University

Authority:

United States: Institutional Review Board

Study ID:

0710003118

NCT ID:

NCT00673673

Start Date:

May 2008

Completion Date:

July 2013

Related Keywords:

  • Gastroesophageal Cancer
  • Gastric Cancer
  • Stomach Neoplasms

Name

Location

Yale University School Of MedicineNew Haven, Connecticut  06520
Medical Oncology & Hematology PCHamden, Connecticut