Clinical trial NCT00366457: Gemcitabine, Bevacizumab and Erlotinib in Pancreatic Cancer
Official title: Phase II Study of Gemcitabine, Bevacizumab and Erlotinib in Locally Advanced and Metastatic Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Cancer
Adenocarcinoma of the Pancreas
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
name: Beth Israel Deaconess Medical Center
name: Dana-Farber Cancer Institute
First posted: 2006-08-21
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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
* 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

Primary outcomes:
measure: Time to Tumor Progression
timeFrame: all patients will be followed for a minimum of 4 months
Secondary outcomes:
measure: Response Rate
timeFrame: after at least one 28-day cycle of treatment
measure: Toxicity Profile
timeFrame: during and after first 28-day cycle of treatment
measure: Overall Survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Lawrence S. Blaszkowsky, MD
role: PRINCIPAL_INVESTIGATOR
References: