Gemcitabine, Bevacizumab and Erlotinib in Pancreatic Cancer

Phase 2

Completed

• Conditions: Pancreatic Cancer; Adenocarcinoma of the Pancreas
• Interventions: Drug: Bevacizumab; Drug: Erlotinib; Drug: Gemcitabine

• Registration Number: NCT00366457
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2006-08-17
• Study First Submitted QC: 2006-08-17
• Study First Posted: 2006-08-21
• Primary Completion: 2008-08
• Study Completion: 2011-07
• Results First Submitted: 2017-02-14
• Results First Submitted QC: 2017-02-14
• Results First Posted: 2017-03-31
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-07
• Last Update Posted: 2017-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gemcitabine, Bevacizumab and Erlotinib	Erlotinib	single-arm, no masking
Gemcitabine, Bevacizumab and Erlotinib	Bevacizumab	single-arm, no masking
Gemcitabine, Bevacizumab and Erlotinib	Gemcitabine	single-arm, no masking

Primary Outcome Measures

Name	Time	Method
Time to Tumor Progression	all patients will be followed for a minimum of 4 months	Time to tumor progression (TTP) = time from date of initial treatment to first objective documentation of progressive disease or death; patients who die without a reported prior progression will be considered to have progressed on the day of their death.; Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Secondary Outcome Measures

Name	Time	Method
Response Rate	after at least one 28-day cycle of treatment	Response rate using RECIST criteria and latest time point available. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Toxicity Profile	during and after first 28-day cycle of treatment	Grade 3-4 treatment-related toxicities (treatment-related = possible, probable, or definite) Grading system: 1= mild, 2 = moderate, 3 = severe, 4 = life-threatening
Overall Survival	5 years	overall survival (OS) = time from study entry until death from any cause

Trial Locations

Locations (3)

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States