Status:
COMPLETED
Gemcitabine, Bevacizumab and Erlotinib in Pancreatic Cancer
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Genentech, Inc.
Beth Israel Deaconess Medical Center
Conditions:
Pancreatic Cancer
Adenocarcinoma of the Pancreas
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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. Bevacizuma...
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 intrave...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00366457
Start Date
August 1 2006
End Date
July 1 2011
Last Update
May 15 2017
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115