Phase II Study of Gemcitabine, Bevacizumab and Erlotinib in Locally Advanced and Metastatic Pancreatic Cancer
Overview
- Phase
- Phase 2
- Intervention
- Bevacizumab
- Conditions
- Pancreatic Cancer
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 32
- Locations
- 3
- Primary Endpoint
- Time to Tumor Progression
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Detailed Description
* 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.
Investigators
Lawrence S. Blaszkowsky, MD
Assistant Physician
Massachusetts General Hospital
Eligibility Criteria
Inclusion Criteria
- •Previously untreated patients with unresectable or metastatic adenocarcinoma of the pancreas
- •ECOG Performance Status 0-2
- •18 years of age or older
- •Radiographically measurable disease
- •Expected survival of at least 4 months
- •Creatinine of \</= 2.0
- •Adequate hepatic function
- •Adequate hematopoietic function
- •Use of effective means of contraception in subjects of child-bearing potential
Exclusion Criteria
- •Warfarin anticoagulation
- •Prior treatment with a tyrosine kinase inhibitor, EGFR inhibitor, or VEGF inhibitor
- •Coexistent malignant disease
- •Current or recent (within 4 weeks) participation in a clinical trial
- •Pregnancy
- •Documented invasion of adjacent organs or major blood vessels
- •Blood pressure of \> 150/100mmHg
- •Unstable angina
- •NYHA Grade II or greater congestive heart failure
- •History of myocardial infarction or stroke within 6 months
Arms & Interventions
Gemcitabine, Bevacizumab and Erlotinib
single-arm, no masking
Intervention: Bevacizumab
Gemcitabine, Bevacizumab and Erlotinib
single-arm, no masking
Intervention: Erlotinib
Gemcitabine, Bevacizumab and Erlotinib
single-arm, no masking
Intervention: Gemcitabine
Outcomes
Primary Outcomes
Time to Tumor Progression
Time Frame: all patients will be followed for a minimum of 4 months
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.
Secondary Outcomes
- Response Rate(after at least one 28-day cycle of treatment)
- Toxicity Profile(during and after first 28-day cycle of treatment)
- Overall Survival(5 years)