Phase II Study of Gemcitabine, Bevacizumab and Erlotinib in Locally Advanced and Metastatic Pancreatic Cancer
18 Years
N/A
Both
Pancreatic Cancer, Adenocarcinoma of the Pancreas
Trial Information
Phase II Study of Gemcitabine, Bevacizumab and Erlotinib in Locally Advanced and Metastatic 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.
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
- 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
- Clinically significant peripheral vascular disease
- Evidence of bleeding diathesis of coagulopathy
- Presence of CNS or brain metastases
- Major surgical procedure, open biopsy, or significant traumatic event within 28 days
- Minor surgical procedures, fine needle aspirations or core biopsies within 7 days
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess within 6 months
- Serious non-healing wound, ulcer or bone fracture
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Determine the time to tumor progression on the combination of gemcitabine with bevacizumab and erlotinib.
Outcome Time Frame:
TBD
Safety Issue:
No
Principal Investigator
Lawrence S. Blaszkowsky, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Massachusetts General Hospital
Authority:
United States: Institutional Review Board
Study ID:
05-234
NCT ID:
NCT00366457
Start Date:
August 2006
Completion Date:
July 2011
Related Keywords:
- Pancreatic Cancer
- Adenocarcinoma of the Pancreas
- Adenocarcinoma
- Adenocarcinoma, Mucinous
- Pancreatic Neoplasms
Name | Location |
|---|---|
| Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
| Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
| Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
