FOLFOX With Bevacizumab in Metastatic or Unresectable Gastroesophageal and Gastric Cancer
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Jill Lacy, Yale University
First received: May 5, 2008
Last updated: February 25, 2013
Last verified: February 2013
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.
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Phase II Study of FOLFOX With Bevacizumab (Avastin(TM)) in Metastatic or Unresectable Gastroesophageal and Gastric Cancer
Primary Outcome Measures:
- Time to Progression (TTP) [ Time Frame: Upon completion of study ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Response rate by RECIST criteria [ Time Frame: Upon completion of study ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Upon completion of study ] [ Designated as safety issue: No ]
- Evaluation of toxicity and tolerability [ Time Frame: Upon completion of study ] [ Designated as safety issue: Yes ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||July 2013 (Final data collection date for primary outcome measure)
FOLFOX in combination with bevacizumab
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 will be used at a dose of 10 mg/kg administered every 2 weeks on day one of FOLFOX chemotherapy
Other Name: Avastin
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00673673
|Medical Oncology & Hematology PC
|Hamden, Connecticut, United States |
|Yale University School of Medicine
|New Haven, Connecticut, United States, 06520 |
||Jill Lacy, M.D.
No publications provided
||Jill Lacy, Principal Investigator, Yale University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 5, 2008
||February 25, 2013
||United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 05, 2013
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Angiogenesis Modulating Agents