A Phase II Trial of Bevacizumab Plus Gemcitabine™ and Oxaliplatin™ as First Line Therapy in Metastatic or Locally Advanced (Unresectable) Pancreatic Cancer
Overview
- Phase
- Phase 2
- Intervention
- oxaliplatin
- Conditions
- Metastatic Pancreatic Cancer
- Sponsor
- University of Oklahoma
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- To determine the overall survival (OS) rate at 1 year in this patient population, treated with the combination therapy of bevacizumab plus gemcitabine and oxaliplatin
- Status
- Completed
- Last Updated
- 17 years ago
Overview
Brief Summary
The purpose of this study is to find out if giving patients bevacizumab along with the chemotherapy drugs oxaliplatin and gemcitabine will improve overall survival.
In addition, the study will find out what side effects patients may have by taking bevacizumab, oxaliplatin, and gemcitabine together.
Detailed Description
Design: * A phase II single arm study. All patients receive bevacizumab 10mg/kg and gemcitabine 1000mg/m2 on day 1 followed by oxaliplatin 100mg/m2 on day 2 of a 14 day cycle. Purpose: * The purpose of this study is to find out if giving patients bevacizumab, along with the chemotherapy drugs oxaliplatin and gemcitabine, will improve overall survival. In addition, the study will find out what side effects patients may have by taking bevacizumab, oxaliplatin and gemcitabine together. Enrollment: * Approximately 30 patients will be enrolled to the study between the University of Oklahoma and M.D. Anderson Cancer Center. Duration: * The study will be conducted over approximately 2 years.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age \>/= 18 years old
- •ECOG performance status 0-
- •Patients with metastatic or unresectable locally advanced adenocarcinoma of the pancreas.
- •Patients who have recurrent disease post pancreaticoduodenectomy no earlier than 6 months after resection. Patients with recurrent disease who had completed adjuvant therapy in the form of radiation with or without radiosensitizing 5-fluorouracil (5-FU) 6 months prior to recurrence may be included.
- •Signed informed consent/authorization is obtained prior to conducting any study specific screening procedures.
- •No prior chemotherapy for advanced pancreatic cancer
- •Patient must have measurable disease
- •Use of effective means of contraception (men and women) in subjects of child-bearing potential
- •Obstructive jaundice must be relieved before inclusion
- •Adequate hepatic, renal, and bone marrow function: leukocytes \>= 3,000/uL, absolute neutrophil count \>= 1,500/uL, platelets \>= 100,000/uL, total bilirubin \< = 1.5 X institutional upper limits of normal (ULN), AST (SGOT)/ALT (SGPT) \<= 2.5 X institutional ULN, creatinine \<= 1.5 mg/dL
Exclusion Criteria
- •Previous chemotherapy for pancreatic cancer.
- •Patients who have recurrent disease within 6 months after pancreaticoduodenectomy or had received adjuvant therapy within 6 months of disease recurrence.
- •Uncontrolled intercurrent illness including:
- •Active infection
- •Cardiovascular: New York Heart Association (NYHA) grade II or greater congestive heart failure, unstable angina pectoris, cardiac arrhythmias not well controlled with medication, myocardial infarction within the previous 6 months, blood pressure \> 150/100 mmHg
- •Clinically significant peripheral vascular disease
- •History of stroke within previous 6 months
- •Evidence of bleeding diathesis or coagulopathy
- •Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study.
- •Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to Day 0
Arms & Interventions
1
3-agent treatment group
Intervention: oxaliplatin
1
3-agent treatment group
Intervention: bevacizumab
1
3-agent treatment group
Intervention: gemcitabine
Outcomes
Primary Outcomes
To determine the overall survival (OS) rate at 1 year in this patient population, treated with the combination therapy of bevacizumab plus gemcitabine and oxaliplatin
Time Frame: One year
Secondary Outcomes
- To determine the tolerability and toxicity profile of this regimen in this patient population(One year)
- To determine the objective tumor response rate in this patient population. To determine time to progression (TTP) and progression free survival (PFS) in this patient population(One year)