Combination Chemotherapy for 1st Line Treatment of Advanced or Metastatic Pancreatic Cancer

Metastatic Pancreatic Cancer Clinical Trial

Official title:

A Phase II Trial of Bevacizumab Plus Gemcitabine™ and Oxaliplatin™ as First Line Therapy in Metastatic or Locally Advanced (Unresectable) Pancreatic Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00222469
• Other study ID #: 2004-0652
• Status: Completed
• Phase: Phase 2
• First received: September 20, 2005
• Last updated: July 8, 2008
• Start date: August 2005
• Est. completion date: May 2007

Study information

• Verified date: July 2008
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age >/= 18 years old

• ECOG performance status 0-2.

• 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

• Urine protein:creatinine ratio > 1.0 at screening

• History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to Day 0

• Serious, non-healing wound, ulcer, or bone fracture

• Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurological dysfunction that would confound the evaluation of neurological and other adverse events. A computed tomography (CT) scan of the brain is not needed for eligibility and will be done only if the patient presents with symptoms suggestive of brain metastases.

• Patients may not be receiving any other investigational agents, or have participated in any investigational drug study within 28 days preceding start of study treatment.

• The teratogenic potential of this combination is currently unknown. Women who are pregnant or lactating are excluded.

• History of any other malignancy in the last 5 years, except patients with a prior history of in situ cancer or basal or squamous cell skin cancer.

• Peripheral neuropathy > grade 1

• Psychiatric illness/social situations that would limit compliance with study requirements

Study Design

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

Related Conditions & MeSH terms

• Metastatic Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• bevacizumab
10mg/kg IV on Day 1 Q 2 weeks
• gemcitabine
1000mg/m2 as fixed-rate infusion at 10mg/m2/min on Day 1 and Q 2 weeks.
• oxaliplatin
100mg/m2 on Day 2 and Q 2 weeks.

Locations

Country	Name	City	State
United States	MD Anderson Cancer Center	Houston	Texas
United States	University of Oklahoma	Oklahoma City	Oklahoma

Sponsors (4)

Lead Sponsor	Collaborator
University of Oklahoma	Genentech, Inc., M.D. Anderson Cancer Center, Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		One year	No
Secondary	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	No
Secondary	To determine the tolerability and toxicity profile of this regimen in this patient population		One year	Yes