Liver CancerPhase 1NCT00732836
Hepatic Arterial Infusion (HAI) of Abraxane
A Phase 1 study testing HAI Abraxane, Hepatic Artery Catheter and IV Abraxane in people with Liver Cancer and 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 find the highest tolerated dose of Abraxane (nab-paclitaxel) that can be given directly into the liver of patients with advanced cancer that has spread to the liver. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer, Advanced Cancers, Solid Tumors
- What is being tested?
- HAI Abraxane, Hepatic Artery Catheter and IV Abraxane
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Jan 2016
- 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
- Pathologically confirmed diagnosis of advanced malignancy and liver involvement as predominant site of metastasis.
- An Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Adequate end-organ function as follows: Absolute neutrophil count (ANC) > or = 1500/mm3, Platelets > or = 100,000/mm3, Creatinine < or = 2.0 mg/dL or the calculated Glomerular filtration rate (GFR) > or = 40 mL/min if Creatinine > 2.0 mg/dL, ALT < or = 5 times upper limits of normal, Hb > 9.0 and Bilirubin < or = 2.0 mg/dL.
- Refractory to standard cancer therapy or who have no conventional therapy that produces a complete response rate of at least 10% or an increase in survival of at least 3 months.
- Ability to fully comprehend and willingness to sign the Institutional Review Board (IRB) approved informed consent
- Full recovery from any previous therapy and ability to receive cytotoxic agents.
- Patient is 18 years of age or older
Who cannot join
- Clinically significant ascites.
- Pregnant or breastfeeding females. Women of childbearing potential should be advised to avoid becoming pregnant and men to not father a child while receiving treatment. Women of childbearing potential must have a negative pregnancy test.
- Hypersensitivity to Abraxane
- Untreatable bleeding diathesis
- Evidence of portal vein thrombosis and clinically significant peripheral vascular disease
- Neuropathy of grade 2 or higher
- A known history of central nervous system (CNS) metastasis unless the patients are neurologically stable after treatment with surgery and/or radiation therapy
- If the patient progressed on abraxane previously they will not be eligible for the dose escalation portion or the PK studies only. These patients can be included in the dose expansion portion of the trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Phase I Trial of Hepatic Arterial Infusion of Abraxane With a Pharmacokinetic Study in Advanced Solid Cancer Patients With Predominant Hepatic Metastases
The goal of this clinical research study is find the highest tolerated dose of Abraxane (nab-paclitaxel) that can be given directly into the liver of patients with advanced cancer that has spread to the liver.
Read the detailed description
The Study Drug:
Nab-paclitaxel is designed to block cancer cells from dividing, which may cause the cells to die.
Giving nab-paclitaxel directly into the liver may allow a higher dose of the drug to be given, while avoiding some of the side effects that occur when high doses of chemotherapy are given other ways (for example, by vein into an arm).
Study Drug Dose Level:
If you are found to be eligible to take part in this study, you will be assigned to a study group based on when you joined this study. Up to 9 groups of 6 participants will be enrolled in Part 1 of the study, and up to 18 participants will be enrolled in Part 2. If you are enrolled in Part 1, the dose of the study drug you receive will depend on when you joined this study. The first group of participants will receive the lowest dose level of the study drug. Each new group will receive a higher dose of the study drug than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of the study drug is found. If you are enrolled in Part 2, you will receive the study drug at the highest dose that was tolerated in the Part 1 portion.
Study Drug Administration:
The study drug will be given on Day 1 of "cycles" that are 21 days long. In Cycle 1 only, some participants may receive the study drug through a vein in their arm. The infusion will last 60 minutes. In Cycles 2 and later, you will receive the study drug through a catheter (a thin plastic tube). Each time the catheter is placed, you will be admitted to the hospital.
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 procedure and its risks in more detail.
You will be taken to the Interventional Radiology area, and the catheter will be placed in a blood vessel in your groin area, on the right side of your body. The catheter will be advanced to the liver. The catheter will be carefully taped in order to prevent it from moving or coming out while you are receiving the study drug. You will be on bedrest for the entire time that the catheter is in place.
After having the catheter inserted, you will be taken to the Nuclear Medicine area, and a test called "flow study" will be performed in order to confirm that the catheter is in the right place. The doctor who performs this test will explain it to you in more detail, and you will be asked to sign a separate consent form that describes the procedure and its risks in more detail.
After you return to your room, you will receive the study drug through the catheter over 60 minutes or 4 hours, depending on when you enroll. You will be asked to lie flat on your back while receiving the study drug.
The catheter will be removed by someone experienced in the procedure. It will be removed right after your study drug dose is complete. 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.
You will repeat this procedure once every 21 days. The catheter will be placed and removed each time.
Study Procedures and Tests:
Once a week, including before each dose of the study drug, blood (about 2 teaspoons) will be drawn for routine tests. These blood draws can be done at M. D. Anderson or somewhere else, if there is a place that is more convenient for you.
Once during each cycle (on a day when you are already in clinic), you will have a physical exam, including measurement of height, weight, and vital signs. Urine will be collected for routine tests.
At the end of every 3 cycles, you will have scans performed (the same type of scans as at screening) to check the status of the disease. If the study doctor feels it is appropriate, you may have blood drawn (about 1 teaspoon) to look for tumor markers.
Blood Testing for Research Purposes:
In Cycles 1 and 2, additional blood will be drawn for pharmacokinetic (PK) testing. PK testing measures the amount of study drug in the body at different time points. For participants receiving the study drug over 60 minutes, this blood (about 1 teaspoon each time) will be drawn on Day 1 (before you receive the study drug and at 5, 10, 20 and 40 minutes after the start of the dose, and then at 1, 1½, 2, 3, 4, and 6 hours after the start of the dose). Blood will also be drawn on Day 2 (24 hours after the start of the dose).
For participants receiving the study drug over 4 hours, this blood (about 1 teaspoon each time) will be drawn on Day 1 (before you receive the study drug and at 30 minutes after the start of the dose, and then at 1, 2, 3, 4, 4 ½, 5, 6, 7, and 9 hours after the start of the dose). Blood will also be drawn on Day 2 (24 hours after the start of the dose).
Length of Study Participation:
You will continue to receive the study drug once every 21 days. If the disease gets worse or intolerable side effects occur, you will be taken off the study drug.
End-of-Study Visit:
After your last dose of the study drug, you will have an end-of-study visit. At this visit, the following procedures will be performed:
- You will have a physical exam, including measurement of weight and vital signs.
- Blood (about 2 tablespoons) and urine will be collected for routine tests.
- To check the status of the disease, you will have scans performed (the same types of scans that you had before).
- If the study doctor feels it is appropriate, you may have blood drawn (about 1 teaspoon) to look for tumor markers.
This is an investigational study. Nab-paclitaxel is commercially available and FDA approved for use in breast cancer and for "systemic" use only. Systemic therapies affect the body as a whole. It is investigational to give nab-paclitaxel directly into the liver and to give it to patients with advanced cancer. At this time, giving it directly into the liver of patients with advanced cancer is only being done in research.
Up to 56 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Liver Cancer, Advanced Cancers, Solid Tumors
- Being tested
- HAI Abraxane, Hepatic Artery Catheter, IV Abraxane
- Keywords
- Liver Cancer, Solid Cancer, Abraxane, nab paclitaxel, HAI abraxane, HAI, hepatic arterial infusion, hepatic metastases
- Medical subject headings
- Liver 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 Abraxane, Paclitaxel (protein-bound), Nab-paclitaxel, Abraxane
Escalating doses (beginning dose 180 mg/m^2) starting Day 1, Cycle 2 and later via hepatic arterial infusion (HAI) following IV Abraxane in Day 1, Cycle 1 for 21 day cycles.
Hepatic Artery CatheterProcedure or surgery
Also called HAI
On each day of treatment for Cycles 2-4, hepatic artery catheter placement completed by interventional radiology.
IV AbraxaneDrug
Also called Nab Abraxane, Paclitaxel (protein-bound), Nab-paclitaxel, Abraxane
Intravenous (IV) Abraxane only in Cycle 1 (up to Dose Level 4 of 260 mg/m^2), infused over 60 minutes or 4 hours Day 1 of 21 day cycle.
| Study group | Role | What they receive |
|---|---|---|
| HAI Abraxane MTD | Experimental | Dose escalation beginning Day 1, Cycle 2 dose level 180 mg/m^2 for maximum tolerated dose (MTD) of Hepatic Arterial Infusion of Abraxane (HAI Abraxane) following same dose intravenous Abraxane in Cycle 1 of 21 day cycle. Receives: Drug: HAI Abraxane; Procedure: Hepatic Artery Catheter; Drug: IV Abraxane |
| HAI Abraxane Expansion | Experimental | HAI Abraxane dose expansion at MTD or dose level 3 (260 mg/m^2) if MTD not defined. Receives: Drug: HAI Abraxane; Procedure: Hepatic Artery Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of HAI Abraxane
MTD is highest dose level in which 6 patients with at most 1 patient experiencing a dose limiting toxicity (DLT). Dose escalation continues until DLT is defined or until dose level 4 is completed. DLT defined during first cycle of treatment.
Measured: Assessments every 3 week cycle (21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2008 (estimated)
- Study startJun 2008
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver CancerStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Comprehensive Cancer Network
- Responsible party
- Sponsor
- Investigators
- Siqing Fu, MD, PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00732836
- Sponsor's protocol ID
- 2007-0857
- Other IDs
- NCI-2012-02124
- Status last verified
- Feb 2016
- First submitted
- 8 Aug 2008
- Last updated
- 5 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Siqing F, Culotta KS, Falchook GS, Hong DS, Myers AL, Zhang YP, Naing A, Janku F, Hou MM, Kurzrock R. Pharmacokinetic evaluation of nanoparticle albumin-bound paclitaxel delivered via hepatic arterial infusion in patients with predominantly hepatic metastases. Cancer Chemother Pharmacol. 2016 Feb;77(2):357-64. doi: 10.1007/s00280-015-2946-x. Epub 2015 Dec 23.
PubMed 26698868
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of Hepatic Arterial Infusion of Abraxane With a Pharmacokinetic Study in Advanced Solid Cancer Patients With Predominant Hepatic Metastases
- ClinicalTrials.gov ID
- NCT00732836
- Acronym / sponsor ID
- 2007-0857
- Conditions
- Liver Cancer, Advanced Cancers, Solid Tumors
- Keywords
- Liver Cancer, Solid Cancer, Abraxane, nab paclitaxel, HAI abraxane, HAI, hepatic arterial infusion, hepatic metastases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Comprehensive Cancer Network
- Study start
- Jun 2008
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 12 Aug 2008 (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 find the highest tolerated dose of Abraxane (nab-paclitaxel) that can be given directly into the liver of patients with advanced cancer that has spread to the liver.
Detailed description
The Study Drug:
Nab-paclitaxel is designed to block cancer cells from dividing, which may cause the cells to die.
Giving nab-paclitaxel directly into the liver may allow a higher dose of the drug to be given, while avoiding some of the side effects that occur when high doses of chemotherapy are given other ways (for example, by vein into an arm).
Study Drug Dose Level:
If you are found to be eligible to take part in this study, you will be assigned to a study group based on when you joined this study. Up to 9 groups of 6 participants will be enrolled in Part 1 of the study, and up to 18 participants will be enrolled in Part 2. If you are enrolled in Part 1, the dose of the study drug you receive will depend on when you joined this study. The first group of participants will receive the lowest dose level of the study drug. Each new group will receive a higher dose of the study drug than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of the study drug is found. If you are enrolled in Part 2, you will receive the study drug at the highest dose that was tolerated in the Part 1 portion.
Study Drug Administration:
The study drug will be given on Day 1 of "cycles" that are 21 days long. In Cycle 1 only, some participants may receive the study drug through a vein in their arm. The infusion will last 60 minutes. In Cycles 2 and later, you will receive the study drug through a catheter (a thin plastic tube). Each time the catheter is placed, you will be admitted to the hospital.
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 procedure and its risks in more detail.
You will be taken to the Interventional Radiology area, and the catheter will be placed in a blood vessel in your groin area, on the right side of your body. The catheter will be advanced to the liver. The catheter will be carefully taped in order to prevent it from moving or coming out while you are receiving the study drug. You will be on bedrest for the entire time that the catheter is in place.
After having the catheter inserted, you will be taken to the Nuclear Medicine area, and a test called "flow study" will be performed in order to confirm that the catheter is in the right place. The doctor who performs this test will explain it to you in more detail, and you will be asked to sign a separate consent form that describes the procedure and its risks in more detail.
After you return to your room, you will receive the study drug through the catheter over 60 minutes or 4 hours, depending on when you enroll. You will be asked to lie flat on your back while receiving the study drug.
The catheter will be removed by someone experienced in the procedure. It will be removed right after your study drug dose is complete. 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.
You will repeat this procedure once every 21 days. The catheter will be placed and removed each time.
Study Procedures and Tests:
Once a week, including before each dose of the study drug, blood (about 2 teaspoons) will be drawn for routine tests. These blood draws can be done at M. D. Anderson or somewhere else, if there is a place that is more convenient for you.
Once during each cycle (on a day when you are already in clinic), you will have a physical exam, including measurement of height, weight, and vital signs. Urine will be collected for routine tests.
At the end of every 3 cycles, you will have scans performed (the same type of scans as at screening) to check the status of the disease. If the study doctor feels it is appropriate, you may have blood drawn (about 1 teaspoon) to look for tumor markers.
Blood Testing for Research Purposes:
In Cycles 1 and 2, additional blood will be drawn for pharmacokinetic (PK) testing. PK testing measures the amount of study drug in the body at different time points. For participants receiving the study drug over 60 minutes, this blood (about 1 teaspoon each time) will be drawn on Day 1 (before you receive the study drug and at 5, 10, 20 and 40 minutes after the start of the dose, and then at 1, 1½, 2, 3, 4, and 6 hours after the start of the dose). Blood will also be drawn on Day 2 (24 hours after the start of the dose).
For participants receiving the study drug over 4 hours, this blood (about 1 teaspoon each time) will be drawn on Day 1 (before you receive the study drug and at 30 minutes after the start of the dose, and then at 1, 2, 3, 4, 4 ½, 5, 6, 7, and 9 hours after the start of the dose). Blood will also be drawn on Day 2 (24 hours after the start of the dose).
Length of Study Participation:
You will continue to receive the study drug once every 21 days. If the disease gets worse or intolerable side effects occur, you will be taken off the study drug.
End-of-Study Visit:
After your last dose of the study drug, you will have an end-of-study visit. At this visit, the following procedures will be performed:
- You will have a physical exam, including measurement of weight and vital signs.
- Blood (about 2 tablespoons) and urine will be collected for routine tests.
- To check the status of the disease, you will have scans performed (the same types of scans that you had before).
- If the study doctor feels it is appropriate, you may have blood drawn (about 1 teaspoon) to look for tumor markers.
This is an investigational study. Nab-paclitaxel is commercially available and FDA approved for use in breast cancer and for "systemic" use only. Systemic therapies affect the body as a whole. It is investigational to give nab-paclitaxel directly into the liver and to give it to patients with advanced cancer. At this time, giving it directly into the liver of patients with advanced cancer is only being done in research.
Up to 56 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
- 2
| Arm | Type | Receives |
|---|---|---|
| HAI Abraxane MTD | Experimental | Drug: HAI Abraxane, Procedure: Hepatic Artery Catheter, Drug: IV AbraxaneDose escalation beginning Day 1, Cycle 2 dose level 180 mg/m^2 for maximum tolerated dose (MTD) of Hepatic Arterial Infusion of Abraxane (HAI Abraxane) following same dose intravenous Abraxane in Cycle 1 of 21 day cycle. |
| HAI Abraxane Expansion | Experimental | Drug: HAI Abraxane, Procedure: Hepatic Artery CatheterHAI Abraxane dose expansion at MTD or dose level 3 (260 mg/m^2) if MTD not defined. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Pathologically confirmed diagnosis of advanced malignancy and liver involvement as predominant site of metastasis.
- An Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Adequate end-organ function as follows: Absolute neutrophil count (ANC) > or = 1500/mm3, Platelets > or = 100,000/mm3, Creatinine < or = 2.0 mg/dL or the calculated Glomerular filtration rate (GFR) > or = 40 mL/min if Creatinine > 2.0 mg/dL, ALT < or = 5 times upper limits of normal, Hb > 9.0 and Bilirubin < or = 2.0 mg/dL.
- Refractory to standard cancer therapy or who have no conventional therapy that produces a complete response rate of at least 10% or an increase in survival of at least 3 months.
- Ability to fully comprehend and willingness to sign the Institutional Review Board (IRB) approved informed consent
Key exclusion criteria (8 listed)
- Clinically significant ascites.
- Pregnant or breastfeeding females. Women of childbearing potential should be advised to avoid becoming pregnant and men to not father a child while receiving treatment. Women of childbearing potential must have a negative pregnancy test.
- Hypersensitivity to Abraxane
- Untreatable bleeding diathesis
- Evidence of portal vein thrombosis and 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 |
|---|---|---|
| HAI AbraxaneAlso: Nab Abraxane, Paclitaxel (protein-bound), Nab-paclitaxel, AbraxaneEscalating doses (beginning dose 180 mg/m^2) starting Day 1, Cycle 2 and later via hepatic arterial infusion (HAI) following IV Abraxane in Day 1, Cycle 1 for 21 day cycles. | Drug | HAI Abraxane Expansion, HAI Abraxane MTD |
| Hepatic Artery CatheterAlso: HAIOn each day of treatment for Cycles 2-4, hepatic artery catheter placement completed by interventional radiology. | Procedure or surgery | HAI Abraxane Expansion, HAI Abraxane MTD |
| IV AbraxaneAlso: Nab Abraxane, Paclitaxel (protein-bound), Nab-paclitaxel, AbraxaneIntravenous (IV) Abraxane only in Cycle 1 (up to Dose Level 4 of 260 mg/m^2), infused over 60 minutes or 4 hours Day 1 of 21 day cycle. | Drug | HAI Abraxane MTD |
Primary outcome
Maximum Tolerated Dose (MTD) of HAI Abraxane
Time frame: Assessments every 3 week cycle (21 days)
MTD is highest dose level in which 6 patients with at most 1 patient experiencing a dose limiting toxicity (DLT). Dose escalation continues until DLT is defined or until dose level 4 is completed. DLT defined during first cycle of treatment.
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 5 Feb 2016.
- Derived from this study: PubMed 26698868Siqing F, Culotta KS, Falchook GS, Hong DS, Myers AL, Zhang YP, Naing A, Janku F, Hou MM, Kurzrock R. Pharmacokinetic evaluation of nanoparticle albumin-bound paclitaxel delivered via hepatic arterial infusion in patients with predominantly hepatic metastases. Cancer Chemother Pharmacol. 2016 Feb;77(2):357-64. doi: 10.1007/s00280-015-2946-x. Epub 2015 Dec 23.
- 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.
Siqing Fu, MD, PHD 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 1 study testing HAI Abraxane, Hepatic Artery Catheter and IV Abraxane in people with Liver Cancer and 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 7 inclusion and 8 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 5 Feb 2016. 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 HAI Abraxane (time frame: Assessments every 3 week cycle (21 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00732836, which also lists 1 linked publication.
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 5 Feb 2016.