Gemcitabine, Bevacizumab and Erlotinib in Pancreatic Cancer
This study has been completed.
Sponsor:
Massachusetts General Hospital
Collaborators:
Genentech
Beth Israel Deaconess Medical Center
Dana-Farber Cancer Institute
Information provided by (Responsible Party):
Lawrence S. Blaszkowsky, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00366457
First received: August 17, 2006
Last updated: April 25, 2012
Last verified: April 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Cancer Adenocarcinoma of the Pancreas |
Drug: Bevacizumab Drug: Erlotinib Drug: Gemcitabine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Gemcitabine, Bevacizumab and Erlotinib in Locally Advanced and Metastatic Pancreatic Cancer |
Resource links provided by NLM:
Drug Information available for:
Gemcitabine
Gemcitabine hydrochloride
Erlotinib hydrochloride
Erlotinib
Bevacizumab
U.S. FDA Resources
Further study details as provided by Massachusetts General Hospital:
Primary Outcome Measures:
- Determine the time to tumor progression on the combination of gemcitabine with bevacizumab and erlotinib. [ Time Frame: TBD ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Determine the response rate and toxicity profile [ Time Frame: TBD ] [ Designated as safety issue: Yes ]
- determine the median survival, 1 year survival, progression free survival and duration of response. [ Time Frame: TBD ] [ Designated as safety issue: No ]
| Enrollment: | 32 |
| Study Start Date: | August 2006 |
| Study Completion Date: | July 2011 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: Bevacizumab
Given intravenously on days 1 and 25 of every 28-day cycle (one every 2 weeks). Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.
Drug: Erlotinib
Taken orally every day. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.
Drug: Gemcitabine
Given intravenously on days 1, 8 and 15 of each 28-day cycle. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.
- 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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00366457
Locations
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02115 | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
Sponsors and Collaborators
Massachusetts General Hospital
Genentech
Beth Israel Deaconess Medical Center
Dana-Farber Cancer Institute
Investigators
| Principal Investigator: | Lawrence S. Blaszkowsky, MD | Massachusetts General Hospital |
More Information
No publications provided
| Responsible Party: | Lawrence S. Blaszkowsky, MD, Assistant Physician, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00366457 History of Changes |
| Other Study ID Numbers: | 05-234 |
| Study First Received: | August 17, 2006 |
| Last Updated: | April 25, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Pancreatic Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous Digestive System Neoplasms Neoplasms by Site Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Gemcitabine |
Erlotinib Bevacizumab Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents |
ClinicalTrials.gov processed this record on May 22, 2013