Pancreatic NeoplasmsPhase 2NCT00336648
Preop Chemoradiation Resectable Pancreas
A Phase 2 study testing Avastin (Bevacizumab), Gemcitabine and Radiation Therapy in people with Pancreatic Neoplasms, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Primary Objective: 1. To assess resectability rate in patients undergoing gemcitabine plus Avastin-based chemoradiation followed by pancreaticoduodenectomy for adenocarcinoma of the pancreas. Secondary Objectives: 1. To assess disease free survival and overall survival 2. To assess margin resection rate (R0 vs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Neoplasms
- What is being tested?
- Avastin (Bevacizumab), Gemcitabine and Radiation Therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Jul 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Cytologic or histologic proof of adenocarcinoma of the pancreatic head or uncinate process is required prior to treatment. Islet cell tumors are not eligible.
- Patients must be staged with a physical exam, CXR, and contrast-enhanced CT. Only potentially resectable patients are eligible. Potentially resectable defined as: a) no extra pancreatic disease, b) no evidence (on CT) of tumor extension to the celiac axis or SMA, and c) no evidence (CT or angiogram) of occlusion of the SMV or SMPV confluence. Visceral angiography is optional. Laparoscopic staging is not part of the pretreatment evaluation for this study. Laparoscopy may be performed prior to planned laparotomy at surgeon's discretion. Staging needs to be done within 28 days of enrollment.
- Patients cannot have known hepatic or peritoneal metastases detected by ultrasound (US), CT scan, or laparotomy prior to chemoradiation.
- There will be no upper age restriction; patients with Karnofsky performance status greater than 70 are eligible.
- Adequate renal, and bone marrow function: Leukocytes greater than or equal to 3,000/uL; Absolute neutrophil count greater than or equal to 1,500/uL; Platelets greater than or equal to 100,000/U1; Serum creatinine less than or equal to 2.0-mg/dL and urine protein: creatinine ratio less than or equal to 1.0 at screening
- Hepatic function (endoscopic or percutaneous drainage as needed) Total bilirubin less than or equal to 2 X institutional upper limits of normal (ULN); AST (SGOT)/ALT (SGPT) less than or equal to 5 X institutional ULN
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- Patients must have no fever or evidence of infection or other coexisting medical condition that would preclude protocol therapy.
- Pregnant women with a positive (blood B-HCG) pregnancy test are excluded from this study; women of childbearing potential (defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must agree to practice adequate contraception and to refrain from breast feeding, as specified in the informed consent.
- Patients must sign a study-specific consent form.
Who cannot join
- Tumors in the body or tail of the pancreas (to the left of the portal -SMV confluence) are not eligible.
- Patients with uncontrolled hypertension, baseline blood pressure of greater than 150/100 mmHg
- Unstable angina or New York Heart Association (NYHA) Grade II or greater congestive heart failure.
- History of myocardial infarction, stroke, DVT, or pulmonary embolism within 6 months of the study
- Clinically significant peripheral vascular disease.
- Known history of bleeding diathesis coagulopathy. If patient has prior documented PT, INR then INR should be less than 2.0 (patients on anticoagulation for atrial fibrillation, other cardiac disorders, and for remote history of thrombosis are not excluded). Lab results should be within 2 weeks of patient enrollment.
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- Known presence of central nervous system or brain metastases.
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study
- Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to Day 0
- Urine protein: creatinine ratio greater than 1.0 at screening; a 24 hour urine protein should be obtained and the level must be less than 1gm/24 hours in order for the patient to be eligible.
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0
- Serious, non-healing wound, ulcer, or bone fracture
- Evidence of duodenal invasion
- Inability to comply with study and/or follow-up procedures
- Patients less than 18 years of age.
Trial locations and contacts
1 site in 1 country.
United States1 site
U.T. M.D. Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Phase II Pilot Study of Preoperative Gemcitabine and Bevacizumab-Based Chemoradiation for Patients With Resectable Adenocarcinoma of the Pancreas
Primary Objective:
- To assess resectability rate in patients undergoing gemcitabine plus Avastin-based chemoradiation followed by pancreaticoduodenectomy for adenocarcinoma of the pancreas.
Secondary Objectives:
- To assess disease free survival and overall survival
- To assess margin resection rate (R0 vs. R1) in these patients
- To assess patterns of failure
Read the detailed description
Gemcitabine is designed to disrupt the growth of the cancer cells, which causes the cancer cells to start to die.
Avastin is designed to prevent or slow down the growth of tumors by its damaging effects on blood vessel growth in tumors.
Before treatment starts, you will have a complete physical exam. Blood (about 2 tablespoons) will be drawn for tests, and a urine test will be performed. Chest x-rays and computed tomography (CT) scans of the abdomen will be done. Women who are able to have children must have a negative blood (1-2 tablespoons) pregnancy test.
If you are found to be eligible to take part in this study, you will receive gemcitabine once a week, Avastin once every 2 weeks, and radiation 5 times a week. Gemcitabine and Avastin will be given on Saturdays, and the radiation will be given Monday through Friday of each week. You will receive this treatment as an outpatient for 6 weeks.
You will receive gemcitabine through a needle in a vein on Days 1, 8, 15, 22, 29, and 36 (+/- 2 days). You will receive Avastin through a needle in a vein every 2 weeks on Days 1, 15, and 29 (+/- 2 days). On the days you receive both drugs, you will receive Avastin over 30-90 minutes and gemcitabine over 40 minutes.
The first dose of Avastin will be given over about 90 minutes. If you do not have a reaction (such as fever/chills), the next dose will be given over about 60 minutes, and if again no reaction occurs, each dose after that will be given over about 30 minutes. If you experience a reaction to the Avastin infusion, you may be given acetaminophen (such as Tylenol) by mouth and/or diphenhydramine (Benadryl) by vein over 30 minutes before each dose to decrease the risk of further reactions.
Radiation will be given Monday through Friday for 5 1/2 weeks. Each day of treatment, you will lie on a treatment table. The radiation therapist will help position your body so that the radiation goes to the right place. A machine will deliver the radiation. It will take about 15-20 minutes to receive the radiation treatment each day.
If any days of radiation are missed, these days will be made up at the end of your treatment (at the end of 28 days) so that you receive the full amount of radiation.
During the study, you will have physical exams weekly while you are receiving chemoradiation, every other week while you are receiving chemotherapy after surgery, and every 4 months during the follow-up period. You will have blood drawn (1-2 tablespoons each time) for routine tests on a weekly basis while you are receiving chemoradiation, every other week while you are taking Avastin after surgery for 3 months, and every 4 months during the follow-up period. The possible development of side effects will be closely monitored and could require extra blood and/or urine samples. You may also have physical exams, blood and urine tests, x-rays, and scans after completing the chemoradiation part of the study, depending upon what is medically needed for evaluation of ongoing therapy.
The overall effect of treatment will be evaluated at least 8 weeks (+/- 2 days) after the completion of chemoradiation. A chest x-ray and CT scans of the chest, abdomen, and pelvis will then be performed, and blood (about 2 tablespoons) will be drawn for routine tests. Some participants will have surgery to remove part of the pancreas, if needed. The reason to wait at least 8 weeks is to allow a safe period of time to pass after the last dose of Avastin to prevent bleeding during surgery. It may also help decrease the risk of postoperative complications, including bleeding and poor wound healing.
This research study allows participants to receive up to 3 infusions of Avastin during the chemoradiation part of the study. If the treatment is shown to benefit you, your doctor may continue to give additional infusions of Avastin every 2 weeks (+/- 2 days) for 3 months after surgery. After the Avastin treatment, you will have a chest x-ray, abdominal CT scan, and blood (about 2 tablespoons) will be drawn for routine tests every 4 months after surgery for 2 years to check the status of the tumor.
This is an investigational study. The study drugs are commercially available and FDA approved, but their use together with radiation is experimental. Avastin is FDA approved for colon and lung cancers but has not been evaluated by the FDA for pancreatic cancer. Gemcitabine is FDA approved for pancreatic cancer. Avastin will be provided free of charge during the study, however the cost of the infusion of the drug will be the responsibility of you and/or your insurance company. The costs of gemcitabine and radiation are considered standard of care, and will be the responsibility of you and/or your insurance company. Up to 31 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Pancreatic Neoplasms
- Being tested
- Avastin (Bevacizumab), Gemcitabine, Radiation Therapy
- Keywords
- Pancreatic Neoplasms, Bevacizumab, Gemcitabine, Radiation Therapy, adenocarcinoma of the pancreatic head, adenocarcinoma of the uncinate process
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avastin (Bevacizumab)Drug
Also called Anti-VEGF monoclonal antibody, rhuMAb-VEGF
10mg/kg by vein (IV) on Days 1, 2, 15 and 29 the adjuvant therapy every two weeks starting approximately 6 weeks after surgery for three months.
GemcitabineDrug
Also called Gemcitabine Hydrochloride, Gemzar
400 mg/m2 IV once a week on Days 1, 2, 8,15, 22, 29, 36 +/-2 days (Saturdays)
Radiation TherapyProcedure or surgery
Also called RT, Radiotherapy
Day 3 +/-2 days (Monday) Start Radiation therapy, Mon -Fri x 28 days; 50.4 Gy prescribed to the 95% isodose at 1.8 Gy/fraction (28 fractions)
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine + Avastin + Surgery | Experimental | Gemcitabine plus Avastin-based chemoradiation followed by pancreaticoduodenectomy Receives: Drug: Avastin (Bevacizumab); Drug: Gemcitabine; Procedure: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients with Resection
Measured: 8 weeks (+/- 2 days) after the completion of chemoradiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2006 (estimated)
- Study startJun 2006
- Primary completionSep 2007
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Douglas Evans, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00336648
- Sponsor's protocol ID
- 2005-0784
- Status last verified
- Jul 2012
- First submitted
- 13 Jun 2006
- Last updated
- 30 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Pilot Study of Preoperative Gemcitabine and Bevacizumab-Based Chemoradiation for Patients With Resectable Adenocarcinoma of the Pancreas
- ClinicalTrials.gov ID
- NCT00336648
- Acronym / sponsor ID
- 2005-0784
- Conditions
- Pancreatic Neoplasms
- Keywords
- Pancreatic Neoplasms, Bevacizumab, Gemcitabine, Radiation Therapy, adenocarcinoma of the pancreatic head, adenocarcinoma of the uncinate process
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Jun 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 14 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objective:
- To assess resectability rate in patients undergoing gemcitabine plus Avastin-based chemoradiation followed by pancreaticoduodenectomy for adenocarcinoma of the pancreas.
Secondary Objectives:
- To assess disease free survival and overall survival
- To assess margin resection rate (R0 vs. R1) in these patients
- To assess patterns of failure
Detailed description
Gemcitabine is designed to disrupt the growth of the cancer cells, which causes the cancer cells to start to die.
Avastin is designed to prevent or slow down the growth of tumors by its damaging effects on blood vessel growth in tumors.
Before treatment starts, you will have a complete physical exam. Blood (about 2 tablespoons) will be drawn for tests, and a urine test will be performed. Chest x-rays and computed tomography (CT) scans of the abdomen will be done. Women who are able to have children must have a negative blood (1-2 tablespoons) pregnancy test.
If you are found to be eligible to take part in this study, you will receive gemcitabine once a week, Avastin once every 2 weeks, and radiation 5 times a week. Gemcitabine and Avastin will be given on Saturdays, and the radiation will be given Monday through Friday of each week. You will receive this treatment as an outpatient for 6 weeks.
You will receive gemcitabine through a needle in a vein on Days 1, 8, 15, 22, 29, and 36 (+/- 2 days). You will receive Avastin through a needle in a vein every 2 weeks on Days 1, 15, and 29 (+/- 2 days). On the days you receive both drugs, you will receive Avastin over 30-90 minutes and gemcitabine over 40 minutes.
The first dose of Avastin will be given over about 90 minutes. If you do not have a reaction (such as fever/chills), the next dose will be given over about 60 minutes, and if again no reaction occurs, each dose after that will be given over about 30 minutes. If you experience a reaction to the Avastin infusion, you may be given acetaminophen (such as Tylenol) by mouth and/or diphenhydramine (Benadryl) by vein over 30 minutes before each dose to decrease the risk of further reactions.
Radiation will be given Monday through Friday for 5 1/2 weeks. Each day of treatment, you will lie on a treatment table. The radiation therapist will help position your body so that the radiation goes to the right place. A machine will deliver the radiation. It will take about 15-20 minutes to receive the radiation treatment each day.
If any days of radiation are missed, these days will be made up at the end of your treatment (at the end of 28 days) so that you receive the full amount of radiation.
During the study, you will have physical exams weekly while you are receiving chemoradiation, every other week while you are receiving chemotherapy after surgery, and every 4 months during the follow-up period. You will have blood drawn (1-2 tablespoons each time) for routine tests on a weekly basis while you are receiving chemoradiation, every other week while you are taking Avastin after surgery for 3 months, and every 4 months during the follow-up period. The possible development of side effects will be closely monitored and could require extra blood and/or urine samples. You may also have physical exams, blood and urine tests, x-rays, and scans after completing the chemoradiation part of the study, depending upon what is medically needed for evaluation of ongoing therapy.
The overall effect of treatment will be evaluated at least 8 weeks (+/- 2 days) after the completion of chemoradiation. A chest x-ray and CT scans of the chest, abdomen, and pelvis will then be performed, and blood (about 2 tablespoons) will be drawn for routine tests. Some participants will have surgery to remove part of the pancreas, if needed. The reason to wait at least 8 weeks is to allow a safe period of time to pass after the last dose of Avastin to prevent bleeding during surgery. It may also help decrease the risk of postoperative complications, including bleeding and poor wound healing.
This research study allows participants to receive up to 3 infusions of Avastin during the chemoradiation part of the study. If the treatment is shown to benefit you, your doctor may continue to give additional infusions of Avastin every 2 weeks (+/- 2 days) for 3 months after surgery. After the Avastin treatment, you will have a chest x-ray, abdominal CT scan, and blood (about 2 tablespoons) will be drawn for routine tests every 4 months after surgery for 2 years to check the status of the tumor.
This is an investigational study. The study drugs are commercially available and FDA approved, but their use together with radiation is experimental. Avastin is FDA approved for colon and lung cancers but has not been evaluated by the FDA for pancreatic cancer. Gemcitabine is FDA approved for pancreatic cancer. Avastin will be provided free of charge during the study, however the cost of the infusion of the drug will be the responsibility of you and/or your insurance company. The costs of gemcitabine and radiation are considered standard of care, and will be the responsibility of you and/or your insurance company. Up to 31 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine + Avastin + Surgery | Experimental | Drug: Avastin (Bevacizumab), Drug: Gemcitabine, Procedure: Radiation TherapyGemcitabine plus Avastin-based chemoradiation followed by pancreaticoduodenectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Cytologic or histologic proof of adenocarcinoma of the pancreatic head or uncinate process is required prior to treatment. Islet cell tumors are not eligible.
- Patients must be staged with a physical exam, CXR, and contrast-enhanced CT. Only potentially resectable patients are eligible. Potentially resectable defined as: a) no extra pancreatic disease, b) no evidence (on CT) of tumor extension to the celiac axis or SMA, and c) no evidence (CT or angiogram) of occlusion of the SMV or SMPV confluence. Visceral angiography is optional. Laparoscopic staging is not part of the pretreatment evaluation for this study. Laparoscopy may be performed prior to planned laparotomy at surgeon's discretion. Staging needs to be done within 28 days of enrollment.
- Patients cannot have known hepatic or peritoneal metastases detected by ultrasound (US), CT scan, or laparotomy prior to chemoradiation.
- There will be no upper age restriction; patients with Karnofsky performance status greater than 70 are eligible.
- Adequate renal, and bone marrow function: Leukocytes greater than or equal to 3,000/uL; Absolute neutrophil count greater than or equal to 1,500/uL; Platelets greater than or equal to 100,000/U1; Serum creatinine less than or equal to 2.0-mg/dL and urine protein: creatinine ratio less than or equal to 1.0 at screening
Key exclusion criteria (15 listed)
- Tumors in the body or tail of the pancreas (to the left of the portal -SMV confluence) are not eligible.
- Patients with uncontrolled hypertension, baseline blood pressure of greater than 150/100 mmHg
- Unstable angina or New York Heart Association (NYHA) Grade II or greater congestive heart failure.
- History of myocardial infarction, stroke, DVT, or pulmonary embolism within 6 months of the study
- Clinically significant peripheral vascular disease.
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 |
|---|---|---|
| Avastin (Bevacizumab)Also: Anti-VEGF monoclonal antibody, rhuMAb-VEGF10mg/kg by vein (IV) on Days 1, 2, 15 and 29 the adjuvant therapy every two weeks starting approximately 6 weeks after surgery for three months. | Drug | Gemcitabine + Avastin + Surgery |
| GemcitabineAlso: Gemcitabine Hydrochloride, Gemzar400 mg/m2 IV once a week on Days 1, 2, 8,15, 22, 29, 36 +/-2 days (Saturdays) | Drug | Gemcitabine + Avastin + Surgery |
| Radiation TherapyAlso: RT, RadiotherapyDay 3 +/-2 days (Monday) Start Radiation therapy, Mon -Fri x 28 days; 50.4 Gy prescribed to the 95% isodose at 1.8 Gy/fraction (28 fractions) | Procedure or surgery | Gemcitabine + Avastin + Surgery |
Primary outcome
Number of Patients with Resection
Time frame: 8 weeks (+/- 2 days) after the completion of chemoradiation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2012.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
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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.
Douglas Evans, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Avastin (Bevacizumab), Gemcitabine and Radiation Therapy in people with Pancreatic Neoplasms, run by M.D. Anderson Cancer Center at 1 site 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 15 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 30 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Patients with Resection (time frame: 8 weeks (+/- 2 days) after the completion of chemoradiation). 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 30 Jul 2012; AzTrials last refreshed its copy on 2 Nov 2026.