Pancreatic CancerPhase 2NCT00366457
Gemcitabine, Bevacizumab and Erlotinib in Pancreatic Cancer
A Phase 2 study testing Bevacizumab, Erlotinib and Gemcitabine in people with Pancreatic Cancer and Adenocarcinoma of the Pancreas, run by Massachusetts General Hospital at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Adenocarcinoma of the Pancreas
- What is being tested?
- Bevacizumab, Erlotinib and Gemcitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2006to Jul 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Adequate hepatic function
- Adequate hematopoietic function
- Use of effective means of contraception in subjects of child-bearing potential
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: Phase II Study of Gemcitabine, Bevacizumab and Erlotinib in Locally Advanced and Metastatic Pancreatic Cancer
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.
Read the 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.
- Conditions
- Pancreatic Cancer, Adenocarcinoma of the Pancreas
- Being tested
- Bevacizumab, Erlotinib, Gemcitabine
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Also called rhuMAb VEGF
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.
ErlotinibDrug
Also called Tarceva
Taken orally every day. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.
GemcitabineDrug
Also called Gemzar
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.
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine, Bevacizumab and Erlotinib | Other | single-arm, no masking Receives: Drug: Bevacizumab; Drug: Erlotinib; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Tumor Progression
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.
Measured: all patients will be followed for a minimum of 4 months
Secondary outcomes (3)
Response Rate
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.
Measured: after at least one 28-day cycle of treatment
Toxicity Profile
Grade 3-4 treatment-related toxicities (treatment-related = possible, probable, or definite) Grading system: 1= mild, 2 = moderate, 3 = severe, 4 = life-threatening
Measured: during and after first 28-day cycle of treatment
Overall Survival
overall survival (OS) = time from study entry until death from any cause
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2006 (estimated)
- Study startAug 2006
- Primary completionAug 2008
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lawrence S. Blaszkowsky, MD, Massachusetts General Hospital
- Investigators
- Lawrence S. Blaszkowsky, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00366457
- Sponsor's protocol ID
- 05-234
- Status last verified
- Apr 2017
- First submitted
- 17 Aug 2006
- Last updated
- 15 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Gemcitabine, Bevacizumab and Erlotinib in Locally Advanced and Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT00366457
- Acronym / sponsor ID
- 05-234
- Conditions
- Pancreatic Cancer, Adenocarcinoma of the Pancreas
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Genentech, Inc., Beth Israel Deaconess Medical Center, Dana-Farber Cancer Institute
- Study start
- Aug 2006
- Primary completion
- Aug 2008 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 21 Aug 2006 (estimated)
- Results
- Posted 31 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine, Bevacizumab and Erlotinib | Other | Drug: Bevacizumab, Drug: Erlotinib, Drug: Gemcitabinesingle-arm, no masking |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BevacizumabAlso: rhuMAb VEGFGiven 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 | Gemcitabine, Bevacizumab and Erlotinib |
| ErlotinibAlso: TarcevaTaken orally every day. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects. | Drug | Gemcitabine, Bevacizumab and Erlotinib |
| GemcitabineAlso: GemzarGiven 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. | Drug | Gemcitabine, Bevacizumab and Erlotinib |
Primary outcome
Time to Tumor Progression
Time frame: 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.
3 secondary outcomes
Response Rate
Time frame: after at least one 28-day cycle of treatment
Toxicity Profile
Time frame: during and after first 28-day cycle of treatment
Overall Survival
Time frame: 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence S. Blaszkowsky, MD principal investigator
Massachusetts General Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bevacizumab, Erlotinib and Gemcitabine in people with Pancreatic Cancer and Adenocarcinoma of the Pancreas, run by Massachusetts General Hospital at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Tumor Progression (time frame: all patients will be followed for a minimum of 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2017.