Advanced CancersPhase 1NCT01057264
HAI Abraxane With Gemcitabine and Bevacizumab
A Phase 1 study testing HAI Abraxane, Gemcitabine and Bevacizumab in people with Advanced Cancers, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to find the highest tolerable dose of Abraxane® (nab-paclitaxel) when given directly into the liver, in combination with Gemzar® (gemcitabine) and Avastin® (bevacizumab) when given by vein. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancers
- What is being tested?
- HAI Abraxane, Gemcitabine and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to May 2014
- Phase
- Phase 1
- 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
- Patients must have histologically confirmed cancer with metastatic liver metastases.
- Patients should be refractory to standard therapy, relapsed after standard therapy, or have no standard therapy that increases survival by at least 3 months, unless the drugs in the protocol regimen are part of the standard of care.
- Performance status Eastern Cooperative Oncology Group (ECOG) 0-2 (capable of all self care but unable to carry out any work activities).
- Adequate renal function (serum creatinine </= 2.0 mg/dL or the calculated glomerular filtration rate (GFR) >/= 40 mL/min if creatinine > 2.0 mg/dL).
- Hepatic function: Total bilirubin </= 5 mg/dL, alanine transaminase (ALT) </= 5 times upper normal reference value.
- Adequate bone marrow function (absolute neutrophil count (ANC) >/= 1500 cells/uL; platelets (PLT) >/= 100,000 cells/uL).
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- At least three weeks from previous cytotoxic chemotherapy before day 1 of hepatic arterial infusion (HAI) infusion. After targeted or biologic therapy there should be 5 half-lives or three weeks, whichever is shorter.
- All females in childbearing age MUST have a negative urine human chorionic gonadotropin (HCG) test unless prior hysterectomy or menopause (defined as age above 55 and six months without menstrual activity). Patients should not become pregnant or breast-feed while on this study. Sexually active patients should use effective birth control.
- Must be >/= 18 years of age.
Who cannot join
- Pregnant females.
- Inability to complete informed consent process and adhere to protocol treatment plan and follow-up requirements.
- Serious or non-healing wound, ulcer or bone fracture.
- History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days.
- Uncontrolled systemic vascular hypertension (systolic blood pressure > 140 mm Hg, diastolic blood pressure > 90 mm Hg).
- Uncontrolled intercurrent illness, including, but not limited to, ongoing or active infection requiring parental antibiotics, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients already in uncompensated liver failure (i.e. Child Pugh Liver Classification C).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study of Hepatic Arterial Infusion (HAI) of Abraxane in Combination With Gemcitabine and Bevacizumab for Patients With Advanced Cancers Metastatic to the Liver
The goal of this clinical research study is to find the highest tolerable dose of Abraxane® (nab-paclitaxel) when given directly into the liver, in combination with Gemzar® (gemcitabine) and Avastin® (bevacizumab) when given by vein.
Read the detailed description
The Study Drugs:
Nab-paclitaxel is designed to block cancer cells from dividing, which may cause the cancer cells to die.
Gemcitabine is designed to disrupt the growth of cancer cells, which may cause cancer cells to die.
Bevacizumab is designed to block the growth of blood vessels that supply the nutrients needed for tumor growth, which may prevent or slow down the growth of cancer cells. Bevacizumab is no longer FDA approved to treat breast cancer.
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to a dose level of the combination of nab-paclitaxel and gemcitabine based on when you join this study. Up to 6 dose levels of nab-paclitaxel and gemcitabine will be tested. All participants will receive the same dose level of bevacizumab, regardless of when you join the study. Between 3-6 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level of the combination of nab-paclitaxel and gemcitabine in combination with bevacizumab. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of the combination of nab-paclitaxel and gemcitabine given in combination with bevacizumab is found.
Once the highest tolerable dose is found, up to 12 additional participants receive this dose. This is called the expansion group.
Catheter Placement:
On Day 1 of each 21-day study cycle, a catheter (a sterile, flexible tube) will be placed into a large artery that carries blood to the liver in your groin area, on the right side of the body. The area where the catheter will be placed will first be numbed with local anesthetic. The catheter will be taped in place to prevent it from moving or coming out while you are receiving nab-paclitaxel. You will lie flat on your back while receiving the study drug, and you will be on bedrest until the catheter is removed.
The doctor who performs the catheter placement procedure will explain it to you in more detail, and you will be asked to sign a separate consent form that describes the catheter placement procedure and its risks in more detail.
After the catheter is in place, you will receive heparin, a drug that is used to help prevent blood clots. Heparin will be started as soon as the catheter is placed and will continue for up to 2 hours.
The catheter will be removed right after you receive nab-paclitaxel. While the catheter is being removed, the study staff will apply pressure to your groin area for 15 minutes in order to stop the bleeding. The catheter will be in place for about 1 hour, or until the nab-paclitaxel administration is complete.
Study Drug Administration:
Nab-paclitaxel will be given through the catheter into the artery that carries blood to your liver nonstop for 1 hour starting on Day 1 of each cycle. If the study doctor thinks it is needed, you will be given drugs by vein to lower the risk of nausea before each dose as part of your standard, routine care.
Gemcitabine will be given by vein over 1 hour on Days 1 and 8 of each cycle.
Bevacizumab will be given by vein on Day 1 of each cycle. The first time you receive bevacizumab, it will be given over 90 minutes. If you tolerate it well, the rest of the doses will be given over 30-60 minutes.
If you do not tolerate the study drug combination well, the doses that you receive may be lowered. If you experience certain side effects, the study drug doses may be delayed and that study cycle may last longer than 21 days.
Starting at least 24 hours after the you receive the study drug on Day 1, you will receive Neupogen® (filgrastim) through a needle injected under the skin. You will continue to receive filgrastim for 3 days (Days 2-4). Filgrastim is being given to help prevent possible side effects related to the other study drugs.
Study Visits:
You will stay in the hospital for up to 7 days (Days 1-7 of each cycle) at the beginning of each cycle, until you recover from any side effects that you may experience. You will be seen by a doctor or "advanced practice" nurse every day while you are in the hospital to check on how you are recovering.
On Day 1 of each cycle:
- You will have a physical exam, including measurement of your weight and vital signs.
- Blood (about 3 teaspoons) will be drawn for routine tests, to test your blood's ability to clot, and tumor marker testing.
On Day 2 of each cycle:
-You will have a physical exam, including measurement of your weight and vital signs.
Every 2 cycles, or at any time the study doctor thinks it is needed, women who are able to become pregnant will have a urine pregnancy test. To remain on this study, the pregnancy test must be negative.
At the end of every 2 cycles (Cycles 2, 4, 6, and so on), or at any time the study doctor thinks it is needed, a chest x-ray, CT scan, MRI scan, PET scan and/or PET/CT scan will be performed to check the status of the disease. After 10 cycles of study drug treatment, you may have scans every 3 cycles instead of 2 cycles, if your doctor feels that this is in your best interest. If the study doctor thinks it is better for you, other types of scans that have not been listed here may be performed.
Follow-Up Visit:
Six (6) weeks after the last dose of the study drug combination, or if you stop taking the study drug combination for any reason, the following tests and procedures will be performed:
- You will have a physical exam.
- Your performance status will be recorded.
- Blood (about 2 teaspoons) will be drawn for routine tests and to test your blood's ability to clot.
- If the study doctor thinks it is needed, a chest x-ray, CT scan, MRI scan, PET scan and/or PET/CT scan will be performed to check the status of the disease. If the study doctor thinks it is better for you, other types of scans that have not been listed here may be performed.
Length of Study:
You may continue taking the study drug combination for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if the disease gets worse or intolerable side effects occur.
This is an investigational study. Nab-paclitaxel is FDA approved and commercially available when given by vein for the treatment of breast cancer.
Gemcitabine is FDA approved and commercially available for the treatment of pancreatic cancer, breast cancer that is metastatic (has spread to other parts of the body), non-small cell lung cancer (NSCL), and ovarian cancer. Bevacizumab is FDA approved and commercially available for the treatment of metastatic colorectal cancer, NSCL, and a type of brain cancer called glioblastoma multiforme.
Giving nab-paclitaxel into an artery that carries blood directly into the liver is investigational. Using the study drug combination for treating advanced cancer that has spread to the liver is investigational.
Up to 80 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Advanced Cancers
- Being tested
- HAI Abraxane, Gemcitabine, Bevacizumab, Filgrastim
- Keywords
- Liver, Cancer, Hepatic arterial infusion, HAI, Abraxane, Nab-Paclitaxel, Paclitaxel, ABI-007, Gemcitabine, Gemcitabine Hydrochloride, Gemzar, Bevacizumab, Avastin, Anti-VEGF monoclonal antibody, rhuMAb-VEGF, Filgrastim, G-CSF, Neupogen
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HAI AbraxaneDrug
Also called Nab-paclitaxel, Paclitaxel (protein bound), ABI-007
Starting dose: 120 mg/m^2 by HAI infusion over 24 hours on Day 1 of 21 day cycle
GemcitabineDrug
Also called Gemzar, Gemcitabine Hydrochloride
Starting dose: 600 mg/m^2 by IV on Days 1 and 8 of 21 day cycle
BevacizumabDrug
Also called Avastin, Anti-VEGF monoclonal antibody, rhuMAb-VEGF
10 mg/kg IV on Day 1 of 21 day cycle
FilgrastimDrug
Also called G-CSF, Neupogen
5 mcg/kg subcutaneously starting at least 24 hours after Day 1 completion of chemotherapy, for 3 days.
| Study group | Role | What they receive |
|---|---|---|
| HAI Abraxane + Gemcitabine + Bevacizumab | Experimental | HAI (hepatic arterial infusions) Abraxane with Gemcitabine + Bevacizumab Receives: Drug: HAI Abraxane; Drug: Gemcitabine; Drug: Bevacizumab; Drug: Filgrastim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of Escalating Doses of Hepatic Arterial Infusions of Abraxane in Combination with Gemcitabine and Bevacizumab
If not more than 33% of the patients in the cohort develop dose limiting toxicities (DLT), this cohort considered maximum tolerated dose (MTD). Dose-limiting toxicity (DLT) defined as any grade 3 or 4 non-hematologic toxicity as defined in the most current version of NCI Common Toxicity Criteria for Adverse Effects (CTCAE). MTD defined by DLTs that occur in the first cycle.
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancersStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Apostolia M. Tsimberidou, MD, PHD, Study chair, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01057264
- Sponsor's protocol ID
- 2009-0741
- Other IDs
- NCI-2011-00555
- Status last verified
- Nov 2015
- First submitted
- 25 Jan 2010
- Last updated
- 18 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Hepatic Arterial Infusion (HAI) of Abraxane in Combination With Gemcitabine and Bevacizumab for Patients With Advanced Cancers Metastatic to the Liver
- ClinicalTrials.gov ID
- NCT01057264
- Acronym / sponsor ID
- 2009-0741
- Conditions
- Advanced Cancers
- Keywords
- Liver, Cancer, Hepatic arterial infusion, HAI, Abraxane, Nab-Paclitaxel, Paclitaxel, ABI-007
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 27 Jan 2010 (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.
The goal of this clinical research study is to find the highest tolerable dose of Abraxane® (nab-paclitaxel) when given directly into the liver, in combination with Gemzar® (gemcitabine) and Avastin® (bevacizumab) when given by vein.
Detailed description
The Study Drugs:
Nab-paclitaxel is designed to block cancer cells from dividing, which may cause the cancer cells to die.
Gemcitabine is designed to disrupt the growth of cancer cells, which may cause cancer cells to die.
Bevacizumab is designed to block the growth of blood vessels that supply the nutrients needed for tumor growth, which may prevent or slow down the growth of cancer cells. Bevacizumab is no longer FDA approved to treat breast cancer.
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to a dose level of the combination of nab-paclitaxel and gemcitabine based on when you join this study. Up to 6 dose levels of nab-paclitaxel and gemcitabine will be tested. All participants will receive the same dose level of bevacizumab, regardless of when you join the study. Between 3-6 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level of the combination of nab-paclitaxel and gemcitabine in combination with bevacizumab. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of the combination of nab-paclitaxel and gemcitabine given in combination with bevacizumab is found.
Once the highest tolerable dose is found, up to 12 additional participants receive this dose. This is called the expansion group.
Catheter Placement:
On Day 1 of each 21-day study cycle, a catheter (a sterile, flexible tube) will be placed into a large artery that carries blood to the liver in your groin area, on the right side of the body. The area where the catheter will be placed will first be numbed with local anesthetic. The catheter will be taped in place to prevent it from moving or coming out while you are receiving nab-paclitaxel. You will lie flat on your back while receiving the study drug, and you will be on bedrest until the catheter is removed.
The doctor who performs the catheter placement procedure will explain it to you in more detail, and you will be asked to sign a separate consent form that describes the catheter placement procedure and its risks in more detail.
After the catheter is in place, you will receive heparin, a drug that is used to help prevent blood clots. Heparin will be started as soon as the catheter is placed and will continue for up to 2 hours.
The catheter will be removed right after you receive nab-paclitaxel. While the catheter is being removed, the study staff will apply pressure to your groin area for 15 minutes in order to stop the bleeding. The catheter will be in place for about 1 hour, or until the nab-paclitaxel administration is complete.
Study Drug Administration:
Nab-paclitaxel will be given through the catheter into the artery that carries blood to your liver nonstop for 1 hour starting on Day 1 of each cycle. If the study doctor thinks it is needed, you will be given drugs by vein to lower the risk of nausea before each dose as part of your standard, routine care.
Gemcitabine will be given by vein over 1 hour on Days 1 and 8 of each cycle.
Bevacizumab will be given by vein on Day 1 of each cycle. The first time you receive bevacizumab, it will be given over 90 minutes. If you tolerate it well, the rest of the doses will be given over 30-60 minutes.
If you do not tolerate the study drug combination well, the doses that you receive may be lowered. If you experience certain side effects, the study drug doses may be delayed and that study cycle may last longer than 21 days.
Starting at least 24 hours after the you receive the study drug on Day 1, you will receive Neupogen® (filgrastim) through a needle injected under the skin. You will continue to receive filgrastim for 3 days (Days 2-4). Filgrastim is being given to help prevent possible side effects related to the other study drugs.
Study Visits:
You will stay in the hospital for up to 7 days (Days 1-7 of each cycle) at the beginning of each cycle, until you recover from any side effects that you may experience. You will be seen by a doctor or "advanced practice" nurse every day while you are in the hospital to check on how you are recovering.
On Day 1 of each cycle:
- You will have a physical exam, including measurement of your weight and vital signs.
- Blood (about 3 teaspoons) will be drawn for routine tests, to test your blood's ability to clot, and tumor marker testing.
On Day 2 of each cycle:
-You will have a physical exam, including measurement of your weight and vital signs.
Every 2 cycles, or at any time the study doctor thinks it is needed, women who are able to become pregnant will have a urine pregnancy test. To remain on this study, the pregnancy test must be negative.
At the end of every 2 cycles (Cycles 2, 4, 6, and so on), or at any time the study doctor thinks it is needed, a chest x-ray, CT scan, MRI scan, PET scan and/or PET/CT scan will be performed to check the status of the disease. After 10 cycles of study drug treatment, you may have scans every 3 cycles instead of 2 cycles, if your doctor feels that this is in your best interest. If the study doctor thinks it is better for you, other types of scans that have not been listed here may be performed.
Follow-Up Visit:
Six (6) weeks after the last dose of the study drug combination, or if you stop taking the study drug combination for any reason, the following tests and procedures will be performed:
- You will have a physical exam.
- Your performance status will be recorded.
- Blood (about 2 teaspoons) will be drawn for routine tests and to test your blood's ability to clot.
- If the study doctor thinks it is needed, a chest x-ray, CT scan, MRI scan, PET scan and/or PET/CT scan will be performed to check the status of the disease. If the study doctor thinks it is better for you, other types of scans that have not been listed here may be performed.
Length of Study:
You may continue taking the study drug combination for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if the disease gets worse or intolerable side effects occur.
This is an investigational study. Nab-paclitaxel is FDA approved and commercially available when given by vein for the treatment of breast cancer.
Gemcitabine is FDA approved and commercially available for the treatment of pancreatic cancer, breast cancer that is metastatic (has spread to other parts of the body), non-small cell lung cancer (NSCL), and ovarian cancer. Bevacizumab is FDA approved and commercially available for the treatment of metastatic colorectal cancer, NSCL, and a type of brain cancer called glioblastoma multiforme.
Giving nab-paclitaxel into an artery that carries blood directly into the liver is investigational. Using the study drug combination for treating advanced cancer that has spread to the liver is investigational.
Up to 80 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HAI Abraxane + Gemcitabine + Bevacizumab | Experimental | Drug: HAI Abraxane, Drug: Gemcitabine, Drug: Bevacizumab, Drug: FilgrastimHAI (hepatic arterial infusions) Abraxane with Gemcitabine + Bevacizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients must have histologically confirmed cancer with metastatic liver metastases.
- Patients should be refractory to standard therapy, relapsed after standard therapy, or have no standard therapy that increases survival by at least 3 months, unless the drugs in the protocol regimen are part of the standard of care.
- Performance status Eastern Cooperative Oncology Group (ECOG) 0-2 (capable of all self care but unable to carry out any work activities).
- Adequate renal function (serum creatinine </= 2.0 mg/dL or the calculated glomerular filtration rate (GFR) >/= 40 mL/min if creatinine > 2.0 mg/dL).
- Hepatic function: Total bilirubin </= 5 mg/dL, alanine transaminase (ALT) </= 5 times upper normal reference value.
Key exclusion criteria (7 listed)
- Pregnant females.
- Inability to complete informed consent process and adhere to protocol treatment plan and follow-up requirements.
- Serious or non-healing wound, ulcer or bone fracture.
- History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days.
- Uncontrolled systemic vascular hypertension (systolic blood pressure > 140 mm Hg, diastolic blood pressure > 90 mm Hg).
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 |
|---|---|---|
| HAI AbraxaneAlso: Nab-paclitaxel, Paclitaxel (protein bound), ABI-007Starting dose: 120 mg/m^2 by HAI infusion over 24 hours on Day 1 of 21 day cycle | Drug | HAI Abraxane + Gemcitabine + Bevacizumab |
| GemcitabineAlso: Gemzar, Gemcitabine HydrochlorideStarting dose: 600 mg/m^2 by IV on Days 1 and 8 of 21 day cycle | Drug | HAI Abraxane + Gemcitabine + Bevacizumab |
| BevacizumabAlso: Avastin, Anti-VEGF monoclonal antibody, rhuMAb-VEGF10 mg/kg IV on Day 1 of 21 day cycle | Drug | HAI Abraxane + Gemcitabine + Bevacizumab |
| FilgrastimAlso: G-CSF, Neupogen5 mcg/kg subcutaneously starting at least 24 hours after Day 1 completion of chemotherapy, for 3 days. | Drug | HAI Abraxane + Gemcitabine + Bevacizumab |
Primary outcome
Maximum Tolerated Dose (MTD) of Escalating Doses of Hepatic Arterial Infusions of Abraxane in Combination with Gemcitabine and Bevacizumab
Time frame: 21 days
If not more than 33% of the patients in the cohort develop dose limiting toxicities (DLT), this cohort considered maximum tolerated dose (MTD). Dose-limiting toxicity (DLT) defined as any grade 3 or 4 non-hematologic toxicity as defined in the most current version of NCI Common Toxicity Criteria for Adverse Effects (CTCAE). MTD defined by DLTs that occur in the first cycle.
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 18 Nov 2015.
- University of Texas 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.
Apostolia M. Tsimberidou, MD, PHD study chair
UT MD 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 1 study testing HAI Abraxane, Gemcitabine and Bevacizumab in people with Advanced Cancers, 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 7 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 18 Nov 2015. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Maximum Tolerated Dose (MTD) of Escalating Doses of Hepatic Arterial Infusions of Abraxane in Combination with Gemcitabine and Bevacizumab (time frame: 21 days). 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 18 Nov 2015.