Phase 2
N=32
Gemcitabine, Bevacizumab and Erlotinib in Pancreatic Cancer
Pancreatic Cancer · Adenocarcinoma of the Pancreas
Bottom Line
View on ClinicalTrials.gov: NCT00366457 ↗Enrolled (actual)
32
Serious AEs
36.7%
Results posted
Mar 2017
Primary outcome: Primary: Time to Tumor Progression — 3.5 months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Bevacizumab (Drug); Erlotinib (Drug); Gemcitabine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Aug 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Tumor Progression |
3.5 | — |
| SECONDARY Response Rate |
1; 8; 19 | — |
| SECONDARY Toxicity Profile |
4; 3; 2; 2; 2; 2 | — |
| SECONDARY Overall Survival |
6.7 | — |
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.
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 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
Data sourced from ClinicalTrials.gov (NCT00366457). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.