The main purpose of this study is to learn whether or not the combination of gemcitabine, bevacizumab and erlotinib works in treating patients with advanced or metastatic pancreatic cancer. Bevacizumab is a new anti-cancer drug. It is an antibody that works to slow or stop cell growth in cancerous tumors by decreasing the blood supply to the tumors. It is approved by the FDA for the treatment of colorectal cancer but is still considered investigational for treating pancreatic cancer.
* Participants will receive study treatment as an outpatient. The study treatment will be given in time periods called cycles. Each treatment cycle will be 28 days. * Gemcitabine will be given intravenously on days 1, 8, and 15 (once per week for the first three weeks) of the treatment cycle. * Bevacizumab will be given intravenously on days 1 and 15 (once every 2 weeks) of the treatment cycle. * Erlotinib will be taken orally every day of the treatment cycle. * Participants will see the doctor or nurse practitioner every week for the first 28 days of treatment. During all of the following cycles, they will see the doctor or nurse practitioner on day 1 and day 15 of each cycle. * Each 4-week cycle can be repeated until the participant or the doctor decided that they should be removed from the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Given intravenously on days 1 and 25 of every 28-day cycle (one every 2 weeks). Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.
Taken orally every day. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.
Given intravenously on days 1, 8 and 15 of each 28-day cycle. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Time to Tumor Progression
Time to tumor progression (TTP) = time from date of initial treatment to first objective documentation of progressive disease or death; patients who die without a reported prior progression will be considered to have progressed on the day of their death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: all patients will be followed for a minimum of 4 months
Response Rate
Response rate using RECIST criteria and latest time point available. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: 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.
Time frame: after at least one 28-day cycle of treatment
Toxicity Profile
Grade 3-4 treatment-related toxicities (treatment-related = possible, probable, or definite) Grading system: 1= mild, 2 = moderate, 3 = severe, 4 = life-threatening
Time frame: during and after first 28-day cycle of treatment
Overall Survival
overall survival (OS) = time from study entry until death from any cause
Time frame: 5 years
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