Gemcitabine, Bevacizumab and Erlotinib in Pancreatic Cancer
Completed · Phase 2
Conditions studied: Pancreatic Cancer, Adenocarcinoma of the Pancreas
In brief
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.
Key facts
- Study ID
- NCT00366457
- Run by
- Massachusetts General Hospital
- People needed
- 32
- Starts
- 2006-08-01
- Expected to finish
- 2011-07-01
- Last updated by the study team
- 2017-05-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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