MelanomaPhase 1NCT00833807
Hepatic Arterial Infusion of Nab-Paclitaxel in Patients With Metastatic Melanoma in the Liver
A Phase 1 study testing Nab-Paclitaxel (Abraxane) in people with Melanoma and Liver Metastasis, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research is to find the highest tolerable dose of Abraxane (nab-paclitaxel) when given directly to the area where the cancer is located. The safety of this drug will also be studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Liver Metastasis
- What is being tested?
- Nab-Paclitaxel (Abraxane)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Nov 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 histologic confirmation of malignant melanoma, and documented metastatic disease.
- Patients must have at least one clearly measurable metastatic lesion in the liver that is more than 2cm in the largest dimension. Indicator lesions at least 2cm are chosen primarily to have changes in tumor measurement more accurately reflective of effect of therapy, or lack of it.
- Patients must not have received prior systemic chemotherapy with regimens including taxanes. Prior adjuvant treatment with immunotherapy or vaccine therapy is allowed provided there is documentation of disease progression in the liver.
- At least 4 weeks (28 days) since any prior immunotherapy, cytokine, biologic, vaccine therapy or tumor embolization in the liver and patients should have progressed during therapy. Patient must have recovered from any side effects before starting therapy on this protocol.
- At least 4 weeks (28 days) since prior radiotherapy (if radiation therapy field covering > 20% of the bone marrow containing skeletal structures) and prior adjuvant therapy. Patient must have recovered from any side effects before starting therapy on this protocol.
- Lesions being used to assess disease status may not have been radiated or if so, must have progressed during or after radiation therapy.
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- Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2.
- Patients must be >/= 18 years of age. The safety of NAB-Paclitaxel has not been studied in younger patients.
- Patients must have normal serum total bilirubin level, transaminase levels (i.e., ALT and AST) no higher than 2.5 times the institution's upper normal limits. Patients must have adequate renal function: creatinine </= 1.5 mg/dL Patients must have adequate bone marrow function as defined by an absolute neutrophil count >/= 1,500/mm^3, platelet count >/= 100,000/mm^3 and hemoglobin >/= 9.0g/dL.
- Life expectancy of at least 3 months.
- Patients must sign an informed consent form indicating that they are aware of the investigational nature of this study and in keeping with the policies of the institution.
Who cannot join
- Patients who have received prior systemic chemotherapy with regimens including taxanes.
- Patients with history of central nervous system (CNS) metastasis prior to registering to this study.
- Patients who are pregnant or nursing and patients who are not practicing an acceptable method of birth control. A negative pregnancy test (urine or serum) must be documented at baseline for women of childbearing potential. Patients may not breast-feed while on this study.
- Patients with current active infections requiring anti-infectious treatment (e.g., antibiotics, antivirals, or antifungals).
- Patients with current peripheral neuropathy of any etiology that is greater than grade one.
- Patients with unstable or serious concurrent medical conditions are excluded. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent.
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- Patients must not have had major surgery including node dissection, resection of melanoma metastatic to an organ or other surgical procedures that require hospitalization and administration of general anesthesia within the past 14 days.
- Patients must not receive any concurrent chemotherapy, radiotherapy, or immunotherapy while on study.
- Known HIV disease or infection.
- Patients with ascites are not eligible.
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 Study Of Hepatic Arterial Infusion Of Nab-Paclitaxel (Abraxane®) In Patients With Metastatic Melanoma In The Liver
The goal of this clinical research is to find the highest tolerable dose of Abraxane (nab-paclitaxel) when given directly to the area where the cancer is located. The safety of this drug will also be studied.
Read the detailed description
The Study Drug:
Nab-paclitaxel is designed to block cancer cells from dividing, which may cause them to die.
Study Drug Groups:
If you are found to be eligible to take part in this study, you will be assigned to a dose level of nab-paclitaxel based on when you joined this study. Up to 4 dose levels of nab-paclitaxel will be tested. The first group of participants will receive the lowest dose level. 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 nab-paclitaxel is found.
Study Drug Administration:
During Cycles 1-6, you will admitted to the hospital the day before each time you are scheduled to receive the study drug. On the day after you are admitted (Day 1), you will have a catheter inserted into the hepatic artery (the major blood vessel that carries blood to the liver). You will be separately consented for this procedure, which will describe the procedure and its risks in detail. If the melanoma has spread to your skin, you may also be asked to take part in a separate laboratory study. In that study, you will have a tumor biopsy to check the concentration of a protein called SPARC in the tumor. Earlier clinical trials have shown that patients with tumors containing high levels of SPARC have better chance of the tumor shrinking with nab-paclitaxel treatment. You do not have to agree to the laboratory study in order to take part in this main study.
On Day 1 of Cycles 1-6, you will then receive nab-paclitaxel through the arterial catheter over 30 minutes. The catheter will be removed after you receive the study drug.
Your vital signs will be measured before and after you receive the study drug. You will be sent home from the hospital the next day if your vital signs are stable.
On Day 1 of Cycle 7 and beyond, you will receive the study drug through a catheter in your vein over 30 minutes. You will not need to stay in the hospital when you receive the study drug by vein.
On Day 1 of all cycles, before you receive the study drug, you will receive drugs to help to prevent for nausea and vomiting.
Each cycle is 3 weeks.
Study Visits:
On Days 1 and 21 (+ or - 4 days) of every cycle, the following tests and procedures will be performed:
- You will have a physical exam, including measurement of your weight.
- Your medical history will be recorded.
- You will be asked if you have experienced any side effects.
- Blood (about 1 tablespoon) will be drawn for routine tests.
- You will have a performance status evaluation.
On Days 8 and 15 all cycles, blood (about 1 tablespoon) will be drawn for routine tests.
Before each cycle of therapy, you will have a physical exam. Blood (about 2 tablespoons) will be drawn for routine tests.
Before every other cycle beginning with Cycle 3 (Cycles 3, 5, 7 and so on), you will have CT scans to check the status of the disease.
Length of Study:
You may continue to receive the study drug for as long as you are benefitting. You will be taken off study early if you experience intolerable side effects or the disease gets worse.
End-of-Study Visit:
Within 28 days after the last dose of study drug, you will have an end-of-study visit. The following tests and procedures performed:
- You will have a physical exam.
- You will be asked if you have experienced any side effects.
- You will have a chest x-ray, CT scans, and an ECG to check the status of the disease.
- Blood (about 1 tablespoon) and urine will be collected for routine tests.
- You will be asked about any new symptoms that you may have experienced after you stopped receiving the study drug.
- If the doctor thinks it is necessary, you will have an MRI to check the status of the disease.
This is an investigational study. Nab-paclitaxel is FDA approved and commercially available for the treatment of breast cancer when given by vein. Its use in liver cancer patients, as well as its administration into the hepatic artery, is investigational.
Up to 40 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Melanoma, Liver Metastasis
- Being tested
- Nab-Paclitaxel (Abraxane)
- Keywords
- Melanoma, Metastatic Melanoma to the Liver, Liver metastasis, Nab-paclitaxel, Abraxane, Paclitaxel (protein-bound), intraarterial intrahepatic administration, Hepatic Artery, Hepatic Arterial Infusion, Hepatic Administration
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nab-Paclitaxel (Abraxane)Drug
Also called Nab-Paclitaxel (Hepatic administration), Paclitaxel, Paclitaxel (protein-bound)
Day 1 of Cycles 1-6, Starting Dose of 130 mg/m2 received through arterial catheter over 30 minutes. Cycle is 21 Days.
Day 1 of Cycle 7+, Dose received through catheter in vein over 30 minutes. Cycle is 21 Days.
| Study group | Role | What they receive |
|---|---|---|
| Nab-paclitaxel (Abraxane) | Experimental | Day 1 of Cycles 1-6, Starting Dose of 130 mg/m2 received through arterial catheter over 30 minutes. Cycle is 21 Days.
Day 1 of Cycle 7+, Dose received through catheter in vein over 30 minutes. Cycle is 21 Days. Receives: Drug: Nab-Paclitaxel (Abraxane) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of Nab-Paclitaxel
The MTD of nab-paclitaxel in participants with metastatic melanoma, previously untreated with systemic chemotherapy, defined as the dose level prior to that resulting in dose limiting toxicity (DLT) (ie., the highest dose level of nab-paclitaxel at which 0 out of 3 patients or 1 out of 6 patients experience DLT).
Measured: 6 weeks
Secondary outcomes (1)
Survival Rate
Overall survival (OS) defined as time from first date of study treatment until date of subject death from any cause. For subjects who have not died, survival data censored at subjects' last known alive date. Kaplan-Meier method used to estimate distribution and median OS for subjects treated at the MTD level. Progression-free survival (PFS) defined as time from first date of study treatment to documented disease progression, or to death from any cause within 30 days of last dose of study treatment, whichever occurs earlier. Disease response including indicator lesions in the liver assessed by investigator according to Response Evaluation Criteria in Solid Tumors (RECIST).
Measured: After 3, 21 day cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation
- Responsible party
- Sponsor
- Investigators
- Agop Y. Bedikian, MD, BS, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00833807
- Sponsor's protocol ID
- 2006-0603
- Other IDs
- NCI-2010-01023
- Status last verified
- Nov 2015
- First submitted
- 29 Jan 2009
- Last updated
- 26 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study Of Hepatic Arterial Infusion Of Nab-Paclitaxel (Abraxane®) In Patients With Metastatic Melanoma In The Liver
- ClinicalTrials.gov ID
- NCT00833807
- Acronym / sponsor ID
- 2006-0603
- Conditions
- Melanoma, Liver Metastasis
- Keywords
- Melanoma, Metastatic Melanoma to the Liver, Liver metastasis, Nab-paclitaxel, Abraxane, Paclitaxel (protein-bound), intraarterial intrahepatic administration, Hepatic Artery
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Celgene Corporation
- Study start
- Feb 2009
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 2 Feb 2009 (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 is to find the highest tolerable dose of Abraxane (nab-paclitaxel) when given directly to the area where the cancer is located. The safety of this drug will also be studied.
Detailed description
The Study Drug:
Nab-paclitaxel is designed to block cancer cells from dividing, which may cause them to die.
Study Drug Groups:
If you are found to be eligible to take part in this study, you will be assigned to a dose level of nab-paclitaxel based on when you joined this study. Up to 4 dose levels of nab-paclitaxel will be tested. The first group of participants will receive the lowest dose level. 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 nab-paclitaxel is found.
Study Drug Administration:
During Cycles 1-6, you will admitted to the hospital the day before each time you are scheduled to receive the study drug. On the day after you are admitted (Day 1), you will have a catheter inserted into the hepatic artery (the major blood vessel that carries blood to the liver). You will be separately consented for this procedure, which will describe the procedure and its risks in detail. If the melanoma has spread to your skin, you may also be asked to take part in a separate laboratory study. In that study, you will have a tumor biopsy to check the concentration of a protein called SPARC in the tumor. Earlier clinical trials have shown that patients with tumors containing high levels of SPARC have better chance of the tumor shrinking with nab-paclitaxel treatment. You do not have to agree to the laboratory study in order to take part in this main study.
On Day 1 of Cycles 1-6, you will then receive nab-paclitaxel through the arterial catheter over 30 minutes. The catheter will be removed after you receive the study drug.
Your vital signs will be measured before and after you receive the study drug. You will be sent home from the hospital the next day if your vital signs are stable.
On Day 1 of Cycle 7 and beyond, you will receive the study drug through a catheter in your vein over 30 minutes. You will not need to stay in the hospital when you receive the study drug by vein.
On Day 1 of all cycles, before you receive the study drug, you will receive drugs to help to prevent for nausea and vomiting.
Each cycle is 3 weeks.
Study Visits:
On Days 1 and 21 (+ or - 4 days) of every cycle, the following tests and procedures will be performed:
- You will have a physical exam, including measurement of your weight.
- Your medical history will be recorded.
- You will be asked if you have experienced any side effects.
- Blood (about 1 tablespoon) will be drawn for routine tests.
- You will have a performance status evaluation.
On Days 8 and 15 all cycles, blood (about 1 tablespoon) will be drawn for routine tests.
Before each cycle of therapy, you will have a physical exam. Blood (about 2 tablespoons) will be drawn for routine tests.
Before every other cycle beginning with Cycle 3 (Cycles 3, 5, 7 and so on), you will have CT scans to check the status of the disease.
Length of Study:
You may continue to receive the study drug for as long as you are benefitting. You will be taken off study early if you experience intolerable side effects or the disease gets worse.
End-of-Study Visit:
Within 28 days after the last dose of study drug, you will have an end-of-study visit. The following tests and procedures performed:
- You will have a physical exam.
- You will be asked if you have experienced any side effects.
- You will have a chest x-ray, CT scans, and an ECG to check the status of the disease.
- Blood (about 1 tablespoon) and urine will be collected for routine tests.
- You will be asked about any new symptoms that you may have experienced after you stopped receiving the study drug.
- If the doctor thinks it is necessary, you will have an MRI to check the status of the disease.
This is an investigational study. Nab-paclitaxel is FDA approved and commercially available for the treatment of breast cancer when given by vein. Its use in liver cancer patients, as well as its administration into the hepatic artery, is investigational.
Up to 40 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nab-paclitaxel (Abraxane) | Experimental | Drug: Nab-Paclitaxel (Abraxane)Day 1 of Cycles 1-6, Starting Dose of 130 mg/m2 received through arterial catheter over 30 minutes. Cycle is 21 Days. Day 1 of Cycle 7+, Dose received through catheter in vein over 30 minutes. Cycle is 21 Days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients must have histologic confirmation of malignant melanoma, and documented metastatic disease.
- Patients must have at least one clearly measurable metastatic lesion in the liver that is more than 2cm in the largest dimension. Indicator lesions at least 2cm are chosen primarily to have changes in tumor measurement more accurately reflective of effect of therapy, or lack of it.
- Patients must not have received prior systemic chemotherapy with regimens including taxanes. Prior adjuvant treatment with immunotherapy or vaccine therapy is allowed provided there is documentation of disease progression in the liver.
- At least 4 weeks (28 days) since any prior immunotherapy, cytokine, biologic, vaccine therapy or tumor embolization in the liver and patients should have progressed during therapy. Patient must have recovered from any side effects before starting therapy on this protocol.
- At least 4 weeks (28 days) since prior radiotherapy (if radiation therapy field covering > 20% of the bone marrow containing skeletal structures) and prior adjuvant therapy. Patient must have recovered from any side effects before starting therapy on this protocol.
Key exclusion criteria (10 listed)
- Patients who have received prior systemic chemotherapy with regimens including taxanes.
- Patients with history of central nervous system (CNS) metastasis prior to registering to this study.
- Patients who are pregnant or nursing and patients who are not practicing an acceptable method of birth control. A negative pregnancy test (urine or serum) must be documented at baseline for women of childbearing potential. Patients may not breast-feed while on this study.
- Patients with current active infections requiring anti-infectious treatment (e.g., antibiotics, antivirals, or antifungals).
- Patients with current peripheral neuropathy of any etiology that is greater than grade one.
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 |
|---|---|---|
| Nab-Paclitaxel (Abraxane)Also: Nab-Paclitaxel (Hepatic administration), Paclitaxel, Paclitaxel (protein-bound)Day 1 of Cycles 1-6, Starting Dose of 130 mg/m2 received through arterial catheter over 30 minutes. Cycle is 21 Days. Day 1 of Cycle 7+, Dose received through catheter in vein over 30 minutes. Cycle is 21 Days. | Drug | Nab-paclitaxel (Abraxane) |
Primary outcome
Maximum Tolerated Dose (MTD) of Nab-Paclitaxel
Time frame: 6 weeks
The MTD of nab-paclitaxel in participants with metastatic melanoma, previously untreated with systemic chemotherapy, defined as the dose level prior to that resulting in dose limiting toxicity (DLT) (ie., the highest dose level of nab-paclitaxel at which 0 out of 3 patients or 1 out of 6 patients experience DLT).
1 secondary outcome
Survival Rate
Time frame: After 3, 21 day cycles
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 26 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.
Agop Y. Bedikian, MD, BS 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 Nab-Paclitaxel (Abraxane) in people with Melanoma and Liver Metastasis, 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 11 inclusion and 10 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 26 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 Nab-Paclitaxel (time frame: 6 weeks). 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 26 Nov 2015.