Advanced CancerPhase 1NCT00507962
Cisplatin HAI Study in Patients With Advanced Cancer and Dominant Liver Involvement
A Phase 1 study testing Cisplatin and Liposomal Doxorubicin 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 safe dose of cisplatin that can be given with liposomal doxorubicin in the treatment of advanced cancer involving the liver. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- Cisplatin and Liposomal Doxorubicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to May 2011
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with Histologically confirmed diagnosis of malignancy and liver involvement as dominant site of metastasis (over 50% of all tumor burden).
- Pediatric patients eligible at the discretion of the primary investigator.
- Performance Status Equivalent or Grater than 60% in the Karnofsky's Performance scale (Requires occasional assistance but is able to care for own needs).
- Adequate Renal Function (Serum CRE </= 1.5 mg/dL) or calculated Creatinine Clearance >/= 50 ml/min (Cockcroft Formula).
- Adequate Hepatic Function (Total Bilirubin </= 1.5 mg/dL or ALT </= 5 times upper normal reference value).
- Adequate Bone Marrow Function (Absolute neutrophil count (ANC) >/= 1.5 cells/uL; number of platelets (PLT) >/= 100,000 cells/uL).
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- At least three weeks from previous cytotoxic chemotherapy before day 1 of 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 or serum Human chorionic gonadotropin or human chorionic gonadotrophin (hCG) test unless prior hysterectomy or menopause (defined as age above 55 and six months without menstrual activity).
- Ability to fully read, comprehend, and sign informed consent forms. In pediatric patients, the informed consent forms will be signed by a parent or legal guardian.
- Patients with germ cell tumors and lymphoma MUST have had documented progression of disease prior to enrollment.
Who cannot join
- Clinical or radiographic evidence of Ascites.
- Pregnant females.
- Hypersensitivity to platinum compounds or anthracyclines.
- Inability to complete informed consent process and adhere to protocol treatment plan and follow-up requirements.
- Jaundice. (Bilirubin > 1.5 mg/dL).
- Bleeding Diathesis.(Prothrombin time > 20 secs or International Normalized Ratio (INR) > 2.0).
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- Portal vein thrombosis.
- Grade 2 Peripheral Neuropathy (CTC V3.0: Sensory alteration interfering with function but not interfering with ADL)
- Medical History or Clinical Evidence of Congestive Heart Failure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study Dose Escalation Clinical Study Of Hepatic Intraarterial Cisplatin, In Combination With Systemic Intravenous Liposomal Doxorubicin Administered Every Four Weeks to Patients With Advanced Cancer And Dominant Liver Involvement
The goal of this clinical research study is find the highest safe dose of cisplatin that can be given with liposomal doxorubicin in the treatment of advanced cancer involving the liver.
PRIMARY Objectives:
To determine the toxicity and safety of a monthly cytotoxic regimen combining intraarterial hepatic (HAI) cisplatin with systemic intravenous liposomal doxorubicin in patients with cancer metastatic to the liver.
SECONDARY Objectives:
To document in a descriptive fashion the antitumor efficacy of monthly hepatic intraarterial cisplatin in combination with systemic liposomal doxorubicin.
Read the detailed description
Cisplatin and Liposomal Doxorubicin are chemotherapy drugs designed to fight cancer growth.
If you are eligible to take part in this study, you will enter a treatment period that is divided into cycles. Each cycle is 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 avoid 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 will be placed in your right groin. 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 first receive cisplatin through the groin catheter followed by the liposomal doxorubicin given in one of your veins. The treatment lasts less than three hours and is repeated once every month.
The catheter will be carefully taped so it can not move and to prevent it from coming out. Following completion of chemotherapy infusion, the intra-arterial catheter will be pulled and pressure applied to the groin for 15 minutes. 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. The catheter will be removed by the physician on call. The catheter will be placed and removed at each treatment.
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 liposomal doxorubicin.
Since most of the blood flow to your liver comes through the portal vein, your doctors will try to cause an infarct (like a stroke) to the liver artery followed by the injection of cisplatin to kill the tumor cells.
You will be seen by a doctor or advanced practice practitioner every day while you are in the hospital. You will be hospitalized for about 5-7 days until recovery from all immediate treatment related side effects.
You will continue to receive therapy as mentioned above until the disease gets worse or intolerable side effects occur.
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) to make sure your blood counts and the electrolytes (salts in your blood), kidney and liver function are at a safe level.
- Conditions
- Advanced Cancer
- Being tested
- Cisplatin, Liposomal Doxorubicin
- Keywords
- Advanced Cancer, Dominant Liver Involvement, Hepatic Intraarterial Cisplatin, Cisplatin, Liposomal Doxorubicin, Platinol-AQ, Platinol, CDDP, Doxil, Liposomal, Doxorubicin Hydrochloride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CisplatinDrug
Also called Platinol-AQ, Platinol, CDDP
100 mg/m^2 Intraarterial On Day 1 Every 4 Weeks
Liposomal DoxorubicinDrug
Also called Doxil, Liposomal, Doxorubicin Hydrochloride
Starting dose 20 mg/m^2 IV On Day 1 Every 4 Weeks
| Study group | Role | What they receive |
|---|---|---|
| Cisplatin + Liposomal Doxorubicin | Experimental | Cisplatin 100 mg/m^2 Intraarterial and Liposomal Doxorubicin starting dose 20 mg/m^2 by vein on Day 1 every 4 weeks Receives: Drug: Cisplatin; Drug: Liposomal Doxorubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD)
Dose level at which no dose limiting toxicities are seen for a monthly cytotoxic regimen combining intraarterial hepatic cisplatin with systemic intravenous liposomal doxorubicin.
Measured: With each 4 week cycle (28 days)
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 startMar 2005
- Primary completionMay 2011
- Study completionMay 2011
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
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Apostolia Tsimberidou, MD, PhD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00507962
- Sponsor's protocol ID
- 2004-0568
- Status last verified
- Aug 2012
- First submitted
- 25 Jul 2007
- Last updated
- 2 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study Dose Escalation Clinical Study Of Hepatic Intraarterial Cisplatin, In Combination With Systemic Intravenous Liposomal Doxorubicin Administered Every Four Weeks to Patients With Advanced Cancer And Dominant Liver Involvement
- ClinicalTrials.gov ID
- NCT00507962
- Acronym / sponsor ID
- 2004-0568
- Conditions
- Advanced Cancer
- Keywords
- Advanced Cancer, Dominant Liver Involvement, Hepatic Intraarterial Cisplatin, Cisplatin, Liposomal Doxorubicin, Platinol-AQ, Platinol, CDDP
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Mar 2005
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (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 safe dose of cisplatin that can be given with liposomal doxorubicin in the treatment of advanced cancer involving the liver.
PRIMARY Objectives:
To determine the toxicity and safety of a monthly cytotoxic regimen combining intraarterial hepatic (HAI) cisplatin with systemic intravenous liposomal doxorubicin in patients with cancer metastatic to the liver.
SECONDARY Objectives:
To document in a descriptive fashion the antitumor efficacy of monthly hepatic intraarterial cisplatin in combination with systemic liposomal doxorubicin.
Detailed description
Cisplatin and Liposomal Doxorubicin are chemotherapy drugs designed to fight cancer growth.
If you are eligible to take part in this study, you will enter a treatment period that is divided into cycles. Each cycle is 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 avoid 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 will be placed in your right groin. 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 first receive cisplatin through the groin catheter followed by the liposomal doxorubicin given in one of your veins. The treatment lasts less than three hours and is repeated once every month.
The catheter will be carefully taped so it can not move and to prevent it from coming out. Following completion of chemotherapy infusion, the intra-arterial catheter will be pulled and pressure applied to the groin for 15 minutes. 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. The catheter will be removed by the physician on call. The catheter will be placed and removed at each treatment.
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 liposomal doxorubicin.
Since most of the blood flow to your liver comes through the portal vein, your doctors will try to cause an infarct (like a stroke) to the liver artery followed by the injection of cisplatin to kill the tumor cells.
You will be seen by a doctor or advanced practice practitioner every day while you are in the hospital. You will be hospitalized for about 5-7 days until recovery from all immediate treatment related side effects.
You will continue to receive therapy as mentioned above until the disease gets worse or intolerable side effects occur.
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) to make sure your blood counts and the electrolytes (salts in your blood), kidney and liver function are at a safe level.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cisplatin + Liposomal Doxorubicin | Experimental | Drug: Cisplatin, Drug: Liposomal DoxorubicinCisplatin 100 mg/m^2 Intraarterial and Liposomal Doxorubicin starting dose 20 mg/m^2 by vein on Day 1 every 4 weeks |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with Histologically confirmed diagnosis of malignancy and liver involvement as dominant site of metastasis (over 50% of all tumor burden).
- Pediatric patients eligible at the discretion of the primary investigator.
- Performance Status Equivalent or Grater than 60% in the Karnofsky's Performance scale (Requires occasional assistance but is able to care for own needs).
- Adequate Renal Function (Serum CRE </= 1.5 mg/dL) or calculated Creatinine Clearance >/= 50 ml/min (Cockcroft Formula).
- Adequate Hepatic Function (Total Bilirubin </= 1.5 mg/dL or ALT </= 5 times upper normal reference value).
Key exclusion criteria (9 listed)
- Clinical or radiographic evidence of Ascites.
- Pregnant females.
- Hypersensitivity to platinum compounds or anthracyclines.
- Inability to complete informed consent process and adhere to protocol treatment plan and follow-up requirements.
- Jaundice. (Bilirubin > 1.5 mg/dL).
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 |
|---|---|---|
| CisplatinAlso: Platinol-AQ, Platinol, CDDP100 mg/m^2 Intraarterial On Day 1 Every 4 Weeks | Drug | Cisplatin + Liposomal Doxorubicin |
| Liposomal DoxorubicinAlso: Doxil, Liposomal, Doxorubicin HydrochlorideStarting dose 20 mg/m^2 IV On Day 1 Every 4 Weeks | Drug | Cisplatin + Liposomal Doxorubicin |
Primary outcome
Maximum tolerated dose (MTD)
Time frame: With each 4 week cycle (28 days)
Dose level at which no dose limiting toxicities are seen for a monthly cytotoxic regimen combining intraarterial hepatic cisplatin with systemic intravenous liposomal doxorubicin.
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 2 Aug 2012.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Apostolia 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 Cisplatin and Liposomal Doxorubicin 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 2 Aug 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 (MTD) (time frame: With each 4 week cycle (28 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 2 Aug 2012; AzTrials last refreshed its copy on 7 Nov 2026.