FOLFOX With Bevacizumab in Metastatic or Unresectable Gastroesophageal and Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00673673
• Other study ID #: 0710003118
• Status: Completed
• Phase: Phase 2
• First received: May 5, 2008
• Last updated: January 21, 2015
• Start date: May 2008
• Est. completion date: July 2014

Study information

• Verified date: January 2015
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 gastroesophageal and gastric adenocarcinoma. Our primary objective is to determine the time to progression in patients treated with FOLFOX in combination with bevacizumab.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: July 2014
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

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

Related Conditions & MeSH terms

• Gastric Cancer
• Gastroesophageal Cancer
• Stomach Neoplasms

Intervention

Drug:
• FOLFOX
Oxaliplatin 85/mg/m2 IV infused over two hours followed by Leucovorin 400 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus, then 2400 mg/m2 continuous IV infusion over 46-48 hours
• bevacizumab
bevacizumab will be used at a dose of 10 mg/kg administered every 2 weeks on day one of FOLFOX chemotherapy

Locations

Country	Name	City	State
United States	Medical Oncology & Hematology PC	Hamden	Connecticut
United States	Yale University School of Medicine	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival		Upon completion of study, up to 3 years	No
Secondary	Overall Tumor Response Rate by RECIST Criteria	Per response evaulation criteria in solid tumors criteria (RECIST) for target lesions assessed by FDG-PET Scans: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", or similar definition that is accurate and appropriate.	Upon completion of study	No
Secondary	Overall Survival		Upon completion of study, up to 3 years	No