Advanced CancerPhase 1NCT00508326
Paclitaxel Administered by HAI to Patients With Advanced Cancer and Dominant Liver Involvement
A Phase 1 study testing Paclitaxel in people with Advanced Cancer, 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 paclitaxel that can be given directly into the liver of patients with advanced cancer involving the liver. Researchers also want to collect descriptive information on any effects the drug may have on tumor tissue. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Oct 2010
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with histologically confirmed diagnosis of advanced malignancy and liver involvement as dominant site of metastasis.
- Performance status ECOG < or = 2 (Requires occasional assistance but is able to care for own needs).
- Adequate renal function (serum creatinine < 2.0 mg/dL).
- Adequate hepatic function (Total bilirubin < 2.0 mg/dL; ALT </= 5 times upper normal reference value).
- Bone marrow function (ANC >or =1.5 cells/mcL; PLT > or = 100,000 cells/mcL).
- At least three weeks from previous therapy and complete recovery from all associated acute toxicities.
Show all 10Show fewer
- Ability to fully read, comprehend, and sign informed consent forms.
- All females in childbearing age must have a negative urine or serum HCG test unless prior hysterectomy or menopause. Women of childbearing potential and men must use effective birth control.
- Patients should be refractory to standard chemotherapy or have no conventional therapy that produces a CR rate of at least 10% or an increase in survival of at least three months.
- Patients of both genders, 13 year-old or older.
Who cannot join
- Clinical or radiographic evidence of ascites.
- Pregnant or breastfeeding females.
- Hypersensitivity to paclitaxel compounds.
- History of severe hypersensitivity reactions to products containing polyoxyethylated castor oil or Cremophor.
- Inability to complete informed consent process and adhere to protocol treatment plan and follow-up requirements.
- Untreatable bleeding diathesis.
Show all 9Show fewer
- Portal vein thrombosis.
- Peripheral neuropathy > Grade 1 according to NCI CTC v.3.0: sensory alteration not interfering with function).
- Untreated (radiation therapy, chemotherapy, surgery or a combination of modalities) brain metastasis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Study of Paclitaxel Administered by Hepatic Artery Infusion to Patients With Advanced Cancer and Dominant Liver Involvement
The goal of this clinical research study is find the highest tolerated dose of paclitaxel that can be given directly into the liver of patients with advanced cancer involving the liver. Researchers also want to collect descriptive information on any effects the drug may have on tumor tissue.
Read the detailed description
Paclitaxel is designed to work by blocking the mechanisms of cell division in cancer cells, causing them to die.
Before you can start on this study, you will have what are called "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. You will have a complete medical history and physical exam, including measurement of height, weight, and vital signs (blood pressure, temperature, breathing rate, and heart rate). You will have a neurological evaluation evaluating your strength and nerve function. You will be asked to report how a pinprick or a thin brush feel when applied to your skin. About 2 tablespoons of blood and some urine samples will be collected for routine tests. Women who are able to have children must have a negative urine pregnancy test.
If you are eligible to take part in this study, you will begin taking study drugs in cycles of 28 days. You will be hospitalized to receive your chemotherapy. The night of the hospital admission, you will receive fluids (normal saline) in your veins to help decrease the risk of kidney side effects from the chemotherapy. The morning after your admission to the hospital, you will be taken to the interventional radiology suite, and a catheter (a thin plastic tube) will be placed in your groin area and advanced to the liver. You must be on bedrest the entire time that the catheter is in place. After the procedure, you will go to Nuclear Medicine, and a test called "flow study" will be carried out to confirm the right position of the catheter. After your return to the room, the nurses will start the chemotherapy. You will receive paclitaxel nonstop over 24 hours through the catheter (a thin plastic tube) into the artery that carries blood to your liver. You will repeat this procedure once every month.
The catheter will be carefully taped so that it can not move and to prevent it from coming out while you are receiving chemotherapy. You will be asked to lie flat on your back while the treatment takes place. In some cases, the catheter will be removed immediately after your chemotherapy infusions is complete. In some cases, the catheter will remain in longer. You will be on bedrest until the catheter is removed. When the catheter is pulled, pressure will be applied to the groin for 15 minutes. The catheter will be removed by someone experienced in the procedure. The catheter will be placed and removed for each cycle of chemotherapy. Blood (about 2 teaspoons) will be drawn for blood counts and liver function tests, before each dose, to be sure researchers are safely giving you the paclitaxel.
You will be seen by a doctor or advanced practitioner every day while you are in the hospital. You will be hospitalized for about 3-5 days until recovery from all immediate chemotherapy-related side effects. The charges of your hospitalization will be billed to you or your insurance carrier.
You will continue to receive the chemotherapy once every 28 days, unless the disease gets worse or intolerable side effects occur. Every 2 months and at the end of your participation in this study, you will have scans to see if your tumors are growing or shrinking and blood work (about 3 teaspoons) will be performed for safety tests. These tests can be performed at your doctor's office and the results faxed to the study doctor at M. D. Anderson.
In addition, you will be asked to call the research nurse in charge of this study at 713-745-1042 to report on your health status every week for 30 days after the last dose of the drug or until you start a new course of therapy.
This is an investigational study. The chemotherapy you will be given is FDA approved. The cost of being on these medications will be billed to you or your insurance company. About 59 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Advanced Cancer
- Being tested
- Paclitaxel
- Keywords
- Advanced Cancer, Solid Tumor, Liver Metastasis, Hepatic Artery Infusion, Liver, Paclitaxel, Taxol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelDrug
Also called Taxol
Starting dose 150 mg/m^2 HAI once every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| HAI Paclitaxel | Experimental | Paclitaxel via Hepatic Artery Infusion (HAI) Receives: Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose of Monthly Cytotoxic Intraarterial Hepatic Paclitaxel
Measured: Monthly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2007 (estimated)
- Study startOct 2005
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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
- 27 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, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00508326
- Sponsor's protocol ID
- 2005-0092
- Status last verified
- Jul 2012
- First submitted
- 25 Jul 2007
- 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
- Phase I Study of Paclitaxel Administered by Hepatic Artery Infusion to Patients With Advanced Cancer and Dominant Liver Involvement
- ClinicalTrials.gov ID
- NCT00508326
- Acronym / sponsor ID
- 2005-0092
- Conditions
- Advanced Cancer
- Keywords
- Advanced Cancer, Solid Tumor, Liver Metastasis, Hepatic Artery Infusion, Liver, Paclitaxel, Taxol
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Oct 2005
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 27 Jul 2007 (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 paclitaxel that can be given directly into the liver of patients with advanced cancer involving the liver. Researchers also want to collect descriptive information on any effects the drug may have on tumor tissue.
Detailed description
Paclitaxel is designed to work by blocking the mechanisms of cell division in cancer cells, causing them to die.
Before you can start on this study, you will have what are called "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. You will have a complete medical history and physical exam, including measurement of height, weight, and vital signs (blood pressure, temperature, breathing rate, and heart rate). You will have a neurological evaluation evaluating your strength and nerve function. You will be asked to report how a pinprick or a thin brush feel when applied to your skin. About 2 tablespoons of blood and some urine samples will be collected for routine tests. Women who are able to have children must have a negative urine pregnancy test.
If you are eligible to take part in this study, you will begin taking study drugs in cycles of 28 days. You will be hospitalized to receive your chemotherapy. The night of the hospital admission, you will receive fluids (normal saline) in your veins to help decrease the risk of kidney side effects from the chemotherapy. The morning after your admission to the hospital, you will be taken to the interventional radiology suite, and a catheter (a thin plastic tube) will be placed in your groin area and advanced to the liver. You must be on bedrest the entire time that the catheter is in place. After the procedure, you will go to Nuclear Medicine, and a test called "flow study" will be carried out to confirm the right position of the catheter. After your return to the room, the nurses will start the chemotherapy. You will receive paclitaxel nonstop over 24 hours through the catheter (a thin plastic tube) into the artery that carries blood to your liver. You will repeat this procedure once every month.
The catheter will be carefully taped so that it can not move and to prevent it from coming out while you are receiving chemotherapy. You will be asked to lie flat on your back while the treatment takes place. In some cases, the catheter will be removed immediately after your chemotherapy infusions is complete. In some cases, the catheter will remain in longer. You will be on bedrest until the catheter is removed. When the catheter is pulled, pressure will be applied to the groin for 15 minutes. The catheter will be removed by someone experienced in the procedure. The catheter will be placed and removed for each cycle of chemotherapy. Blood (about 2 teaspoons) will be drawn for blood counts and liver function tests, before each dose, to be sure researchers are safely giving you the paclitaxel.
You will be seen by a doctor or advanced practitioner every day while you are in the hospital. You will be hospitalized for about 3-5 days until recovery from all immediate chemotherapy-related side effects. The charges of your hospitalization will be billed to you or your insurance carrier.
You will continue to receive the chemotherapy once every 28 days, unless the disease gets worse or intolerable side effects occur. Every 2 months and at the end of your participation in this study, you will have scans to see if your tumors are growing or shrinking and blood work (about 3 teaspoons) will be performed for safety tests. These tests can be performed at your doctor's office and the results faxed to the study doctor at M. D. Anderson.
In addition, you will be asked to call the research nurse in charge of this study at 713-745-1042 to report on your health status every week for 30 days after the last dose of the drug or until you start a new course of therapy.
This is an investigational study. The chemotherapy you will be given is FDA approved. The cost of being on these medications will be billed to you or your insurance company. About 59 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 |
|---|---|---|
| HAI Paclitaxel | Experimental | Drug: PaclitaxelPaclitaxel via Hepatic Artery Infusion (HAI) |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with histologically confirmed diagnosis of advanced malignancy and liver involvement as dominant site of metastasis.
- Performance status ECOG < or = 2 (Requires occasional assistance but is able to care for own needs).
- Adequate renal function (serum creatinine < 2.0 mg/dL).
- Adequate hepatic function (Total bilirubin < 2.0 mg/dL; ALT </= 5 times upper normal reference value).
- Bone marrow function (ANC >or =1.5 cells/mcL; PLT > or = 100,000 cells/mcL).
Key exclusion criteria (9 listed)
- Clinical or radiographic evidence of ascites.
- Pregnant or breastfeeding females.
- Hypersensitivity to paclitaxel compounds.
- History of severe hypersensitivity reactions to products containing polyoxyethylated castor oil or Cremophor.
- Inability to complete informed consent process and adhere to protocol treatment plan and follow-up requirements.
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 |
|---|---|---|
| PaclitaxelAlso: TaxolStarting dose 150 mg/m^2 HAI once every 4 weeks | Drug | HAI Paclitaxel |
Primary outcome
Maximum Tolerated Dose of Monthly Cytotoxic Intraarterial Hepatic Paclitaxel
Time frame: Monthly
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.
Related trials for Advanced Cancer
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
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 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 Paclitaxel in people with Advanced Cancer, 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 10 inclusion and 9 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 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 of Monthly Cytotoxic Intraarterial Hepatic Paclitaxel (time frame: Monthly). 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.