A Phase II Trial Of Bevacizumab (NSC#704865) Plus Gemcitabine In Patients With Advanced Pancreatic Cancer
Overview
- Phase
- Phase 2
- Intervention
- gemcitabine hydrochloride
- Conditions
- Adenocarcinoma of the Pancreas
- Sponsor
- National Cancer Institute (NCI)
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Objective response rate (complete or partial responses)
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
This phase II trial is to see if combining gemcitabine with bevacizumab works in treating patients who have advanced pancreatic cancer. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Combining chemotherapy with a monoclonal antibody may kill more tumor cells
Detailed Description
PRIMARY OBJECTIVES: I. To determine the objective response rate of patients with advanced pancreatic cancer who are treated with gemcitabine plus bevacizumab. II. To determine the toxicity experienced by patients with advanced pancreatic cancer who are treated with gemcitabine plus bevacizumab. III. To determine median and overall survival of patients with advanced pancreatic cancer who are treated with gemcitabine plus bevacizumab. SECONDARY OBJECTIVES: I. To measure plasma VEGF and serum VCAM-1 levels before, during, and after therapy as a predictor of outcome. II. To collect and store serum samples for possible future assessment of other antiangiogenic inhibition markers. OUTLINE: This is a multicenter study. Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically or cytologically confirmed pancreatic adenocarcinoma
- •Not amenable to curative treatment with surgery or radiotherapy
- •Locally advanced disease must extend outside the boundaries of a standard radiation port
- •At least 1 unidimensionally measurable lesion
- •At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
- •Pleural effusions and ascites not considered measurable lesions
- •No obvious tumor involvement of major vessels on CT scan
- •No known brain metastases
- •Performance status - ECOG 0-2
- •More than 3 months
Exclusion Criteria
- Not provided
Arms & Interventions
Treatment (gemcitabine hydrochloride, bevacizumab)
Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Intervention: gemcitabine hydrochloride
Treatment (gemcitabine hydrochloride, bevacizumab)
Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Intervention: bevacizumab
Treatment (gemcitabine hydrochloride, bevacizumab)
Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Intervention: laboratory biomarker analysis
Outcomes
Primary Outcomes
Objective response rate (complete or partial responses)
Time Frame: Up to 2 years
Secondary Outcomes
- Progression-free survival(Up to 2 years)
- Overall survival(Up to 2 years)