Advanced CancersPhase 1NCT01178112
Trientine and Carboplatin in Advanced Malignancies
A Phase 1 study testing Trientine, Carboplatin and Trientine MTD in people with Advanced Cancers, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to find the highest tolerable dose of the combination of trientine and carboplatin that can be given to patients with advanced cancer. The safety of this drug combination will also be studied. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Advanced Cancers
- What is being tested?
- Trientine, Carboplatin and Trientine MTD
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Aug 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient must have an advanced malignancy that has either failed one or more prior therapies, or for whom there is no established standard of care therapy that prolongs survival by at least 3 months.
- Only in 1 of 3 expansion cohorts, we will plan to enroll 14 subjects with platinum-resistant malignancy. Patient with platinum-resistant malignancy is defined to have had a treatment-free interval of less than 6 months following a platinum-based regimen.
- Patient of any age and any gender. However, those who are 12 years old or younger will be eligible after consultation with their pediatric physicians regarding dose initiation and modification of trientine.
- Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Patient is willing to comply with study procedures and follow-up examinations.
- Patient or primary care taker must be informed of the investigational nature of this study and must sign and give written Institutional Review Board (IRB)-approved informed consent in accordance with institutional guidelines.
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- If patient is of childbearing potential, she or he must agree to practice an effective method of birth control prior to study entry, for the duration of study participation, and for 30 days after the last study dose.
- Patient has adequate organ functions: serum bilirubin </= 2.0 mg/dL; ALT </= 3 x upper limit of normal (ULN), or ALT </= 5 x ULN if the patient has hepatic metastasis; serum creatinine </= 1.5 mg/dL or a calculated creatinine clearance of at least 60 mL/min.
- Patient has adequate bone marrow reserve: absolute neutrophil count (ANC) >/= 1,500 /ul, Platelet count >/= 100,000 /ul , and Hemoglobin >/= 9.0 g/dL.
Who cannot join
- Patient receiving any concurrent chemotherapy.
- Underlying medical condition that might be aggravated by treatment or that cannot be controlled, such as active, uncontrolled, serious infection and cardiac dysfunction.
- Medical and/or psychiatric problems of sufficient severity to limit full compliance with the study or expose patients to undue risk.
- Known anaphylactic or severe hypersensitivity to study drugs or their analogs.
- Patient has failed to recover from any prior surgery within 4 weeks of study entry.
- Patient is pregnant or lactating.
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- Patient has had any treatment specific for tumor control within 3 weeks of dosing with investigational drugs and cytotoxic agents, or within 2 weeks of cytotoxic agent given weekly, or within 6 weeks of nitrosoureas or mitomycin C, or within 5 half-lives of biological targeted agents with half-lives and pharmacodynamic effects lasting less than 5 days (that includes, but is not limited to, erlotinib, sorafenib, sunitinib, bortezomib, and other similar agents), or failure to recover from the toxic effect of any of these therapies prior to study entry.
- Patient has any signs of intestinal obstruction interfering with nutrition.
- Patient has a known history of central nervous system (CNS) metastasis unless the patient has had treatment with surgery or radiation therapy, and is neurologically stable.
- Patient is not able to swallow oral medication.
- Patient has clinical evidence of copper deficiency (i.e. ceruloplasmin level was less than 15 mg/dL or free serum copper level less than 2.2 ug/dL).
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 Trientine and Carboplatin in Patients With Advanced Malignancies
The goal of this clinical research study is to find the highest tolerable dose of the combination of trientine and carboplatin that can be given to patients with advanced cancer. The safety of this drug combination will also be studied.
Read the detailed description
The Study Drugs:
Trientine is designed to remove excess copper in the body, which may cause cancer cells to stop growing.
Carboplatin is designed to block the growth of cancer cells by stopping cell division, which may cause the cells to die.
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to a dose level of carboplatin based on when you joined this study. Up to 3 dose levels of the carboplatin will be tested.
Three (3) to 6 participants will be enrolled at each dose level of carboplatin. The first group of participants will receive the lowest dose level of carboplatin . Each new group will receive a higher dose of the carboplatin than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of the study drug combination is found.
The dose level of trientine will be based on your blood levels of copper. These levels may vary from person to person.
Expansion Groups:
Once the highest tolerable dose of the study drug combination is found, there will be two expansion groups, one group of 28 extra participants (Group A) and one group of 14 extra participants (Group B). Group A will receive the study combination at the highest tolerable dose. Group B will receive extra doses of trientine before starting Day 1 of Cycle 1.
Pharmacokinetic (PK) Groups:
In additional the the Expansion Groups, once the highest tolerable dose of the study drug combination is found, there will also be 2 PK groups. PK testing measures the amount of study drug in the body at different time points. There will be 6 participants in each group. These groups will also receive the study combination at the highest tolerable dose. There will be extra blood draws for both groups and the drug administration schedule will be different from the groups described above.
For all participants, your dose of the study drugs may be lowered if you have any intolerable side effects. You will not receive a higher dose than the dose level that you are first assigned.
Study Drug Administration:
Dose Escalation and Expansion Groups:
On Day 1 of each 28-day cycle, you will receive carboplatin by vein over 2 hours.
Starting on Day 1 of Cycle 1, you will begin taking trientine by mouth several times each day. If you are in Expansion Group B, you will receive extra doses of trientine within the 14 days before Day 1 of Cycle 1. Your study doctor will tell you when to take trientine and whether it should be taken with or without food. You will also be told how many pills to take.
PK Groups:
Both groups will take the study drugs as described above.
However, if you are in PK Group A, instead of on Day 1 of Cycle 1, you will start taking trientine daily beginning on Day 2 of Cycle 1.
If you are in PK Group B, on Day 21 of Cycle 1 and Day 1 of Cycle 2 you will not eat for 2 hours before and 2 hours after you take trientine.
Study Visits:
Within 7 days before the first dose of study drug:
- You will have a physical exam, including measurement of your weight and vital signs.
- You will be asked how well you are able to perform the normal activities of daily living (performance status).
- Blood (about 2 teaspoons) will be drawn for routine tests.
- Blood (about 1 1/2 tablespoons) will be drawn to measure the levels of ceruloplasmin (copper-carrying protein) copper, and iron in your blood.
- Women who are able to become pregnant must have a negative blood (about 1 teaspoon) pregnancy test.
- If your doctor thinks it is needed, you may have an electrocardiogram (ECG) and/or an echocardiogram (ECHO) to check your heart function. An ECG is a test that measures the electrical activity of the heart
Every week until the doctor decides your are taking the correct dose of trientine:
- Blood (about 1 teaspoon) will be drawn for routine tests.
- Blood (about 2 teaspoons) will be drawn to measure the levels of ceruloplasmin in your blood.
Every week during Cycle 1, blood (about 1 teaspoon) will be drawn for routine tests.
Once each cycle:
- Your medical history will be recorded.
- You will have a physical exam, including measurement of your weight and vital signs.
- Your performance status will be recorded.
- Blood (about 2 teaspoons) will be drawn for routine tests.
- If your study doctor thinks it is needed, blood (about 1 tablespoon) will be drawn to measure levels of copper and iron in your blood.
- You will be asked about any side effects you may be having.
At the end of every 2 cycles (Cycles 2, 4, 6, and so on):
- You will have a CT, MRI, PET scan, and/or x-ray to check the status of the disease.
- If the study doctor thinks it is needed, blood (about 1 teaspoon) will be drawn to measure tumor markers.
PK Groups:
If you are in PK Group A, blood (about 1 teaspoon each time) will be drawn:
- On Day 1 of Cycle 1, blood will be drawn 7 times over the 6 hours after you receive carboplatin.
- On Day 2 of Cycle 1, blood will be drawn 1 time.
- On Day 1 of Cycle 2, blood will be drawn 7 times over the 6 hours after you receive carboplatin.
- On Day 2 of Cycle 2, blood will be drawn 1 time.
If you are in PK Group B, blood (about 1 teaspoon each time) will be drawn:
- On Day 21 of Cycle 1, blood will be drawn 7 times over the 6 hours after your dose of trientine.
- On Day 22 of Cycle 1, will be drawn 1 time.
- On Day 1 of Cycle 2, will be drawn 7 times over the 6 hours after you receive carboplatin.
- On Day 2 of Cycle 2, blood will be drawn 1 time.
Length of Study:
You may continue taking the study drugs for as long as the doctor thinks it is in your best interest. You will be taken off study early if the disease gets worse or you experience intolerable side effects.
Your participation on the study will be over once you have completed the end-of-study visit.
End-of-Study Visit:
Within 30 days after your last dose of study drugs, you will have an end-of-study visit. At this visit, the following tests and procedures performed:
- Your medical history will be recorded.
- You will have a physical exam, including measurement of your weight and vital signs.
- Your performance status will be recorded.
- Blood (about 2 teaspoons) will be drawn for routine tests.
- You will be asked about any side effects you may be experiencing.
- If the study doctor thinks it is needed, blood (about 1 teaspoon) will be drawn to measure tumor markers.
- If the study doctor thinks it is needed, you will have a chest x-ray, CT, MRI, and/or PET scan to check the status of the disease.
This is an investigational study. Trientine is FDA approved and commercially available for the treatment of Wilson's disease. Trientine is not FDA approved for the treatment of advanced cancer. Carboplatin is FDA approved and commercially available for the treatment of ovarian cancer. The combination of trientine and carboplatin to treat advanced cancer is investigational.
Up to 72 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Advanced Cancers
- Being tested
- Trientine, Carboplatin, Trientine MTD, Carboplatin MTD, PK Testing
- Keywords
- Metastasis, Carboplatin, Trientine, Chemotherapy
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrientineDrug
Starting dose 750 mg by mouth four times a day, two times with meals and two times without meals for 28 days.
CarboplatinDrug
Also called Paraplatin
Starting dose area under curve (AUC) 4 by vein over two hours on day 1, and once every 28 days.
Trientine MTDDrug
Maximum tolerated dose found in MTD Dose Escalation Group; Carboplatin PK Group A, instead of starting on Day 1 of Cycle 1, starts taking trientine daily beginning on Day 2 of Cycle 1. Trientine PK Group B, 1500 mg of trientine is given once without food on Day 21 of Cycle 1 and once without food after the completion of carboplatin on Day 1 of Cycle 2.
Carboplatin MTDDrug
Also called Paraplatin
Maximum tolerated dose found in MTD Dose Escalation Group
PK TestingOther
Blood samples of 4 mL at following time points: 0, 30, 60 minutes, 2, 3, 4, 6, and 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| Trientine + Carboplatin MTD Group | Experimental | Trientine starting dose 750 mg by mouth four times a day, two times with meals and two times without meals for 28 days. Carboplatin maximum tolerated dose found in MTD Dose Escalation Group. Receives: Drug: Trientine; Drug: Carboplatin |
| MTD Expansion Group | Experimental | Trientine maximum tolerated dose found in MTD Dose Escalation Group; Carboplatin PK Group A, instead of starting on Day 1 of Cycle 1, starts taking trientine daily beginning on Day 2 of Cycle 1. Trientine PK Group B, 1500 mg of trientine is given once without food on Day 21 of Cycle 1 and once without food after the completion of carboplatin on Day 1 of Cycle 2. Carboplatin maximum tolerated dose found in MTD Dose Escalation Group Receives: Drug: Trientine MTD; Drug: Carboplatin MTD |
| Carboplatin PK Expansion Group | Experimental | Trientine maximum tolerated dose found in MTD Dose Escalation Group; Carboplatin PK Group A, instead of starting on Day 1 of Cycle 1, starts taking trientine daily beginning on Day 2 of Cycle 1. Trientine PK Group B, 1500 mg of trientine is given once without food on Day 21 of Cycle 1 and once without food after the completion of carboplatin on Day 1 of Cycle 2. Carboplatin maximum tolerated dose found in MTD Dose Escalation Group. PK testing blood samples of 4 mL at following time points: 0, 30, 60 minutes, 2, 3, 4, 6, and 24 hours. Receives: Drug: Trientine MTD; Drug: Carboplatin MTD; Other: PK Testing |
| Trientine PK Expansion Group | Experimental | Trientine maximum tolerated dose found in MTD Dose Escalation Group; Carboplatin PK Group A, instead of starting on Day 1 of Cycle 1, starts taking trientine daily beginning on Day 2 of Cycle 1. Trientine PK Group B, 1500 mg of trientine is given once without food on Day 21 of Cycle 1 and once without food after the completion of carboplatin on Day 1 of Cycle 2. Carboplatin maximum tolerated dose found in MTD Dose Escalation Group. PK testing blood samples of 4 mL at following time points: 0, 30, 60 minutes, 2, 3, 4, 6, and 24 hours. Receives: Drug: Trientine MTD; Drug: Carboplatin MTD; Other: PK Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of Carboplatin with Trientine
MTD defined by dose limiting toxicities (DLTs) that occur in the first cycle (4 weeks). DLT defined as treatment-related grade 3 or greater nonhematological toxicity other than nausea, vomiting, or fatigue.
Measured: 4 weeks
Secondary outcomes (1)
Treatment Response of Maximum Tolerated Dose (MTD) of Carboplatin with Trientine
Categorization of response based on immune-related response criteria and Response Evaluation Criteria in Solid Tumors (RECIST).
Measured: After 2, 28 day cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2010 (estimated)
- Study startJul 2010
- Primary completionAug 2014
- Study completionAug 2014
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 Advanced CancersStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Siqing Fu, MD, PHD, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01178112
- Sponsor's protocol ID
- 2010-0258
- Other IDs
- NCI-2012-01787
- Status last verified
- Aug 2014
- First submitted
- 6 Aug 2010
- Last updated
- 18 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Fu S, Naing A, Fu C, Kuo MT, Kurzrock R. Overcoming platinum resistance through the use of a copper-lowering agent. Mol Cancer Ther. 2012 Jun;11(6):1221-5. doi: 10.1158/1535-7163.MCT-11-0864. Epub 2012 Apr 5.
PubMed 22491798
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Trientine and Carboplatin in Patients With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT01178112
- Acronym / sponsor ID
- 2010-0258
- Conditions
- Advanced Cancers
- Keywords
- Metastasis, Carboplatin, Trientine, Chemotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 9 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to find the highest tolerable dose of the combination of trientine and carboplatin that can be given to patients with advanced cancer. The safety of this drug combination will also be studied.
Detailed description
The Study Drugs:
Trientine is designed to remove excess copper in the body, which may cause cancer cells to stop growing.
Carboplatin is designed to block the growth of cancer cells by stopping cell division, which may cause the cells to die.
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to a dose level of carboplatin based on when you joined this study. Up to 3 dose levels of the carboplatin will be tested.
Three (3) to 6 participants will be enrolled at each dose level of carboplatin. The first group of participants will receive the lowest dose level of carboplatin . Each new group will receive a higher dose of the carboplatin than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of the study drug combination is found.
The dose level of trientine will be based on your blood levels of copper. These levels may vary from person to person.
Expansion Groups:
Once the highest tolerable dose of the study drug combination is found, there will be two expansion groups, one group of 28 extra participants (Group A) and one group of 14 extra participants (Group B). Group A will receive the study combination at the highest tolerable dose. Group B will receive extra doses of trientine before starting Day 1 of Cycle 1.
Pharmacokinetic (PK) Groups:
In additional the the Expansion Groups, once the highest tolerable dose of the study drug combination is found, there will also be 2 PK groups. PK testing measures the amount of study drug in the body at different time points. There will be 6 participants in each group. These groups will also receive the study combination at the highest tolerable dose. There will be extra blood draws for both groups and the drug administration schedule will be different from the groups described above.
For all participants, your dose of the study drugs may be lowered if you have any intolerable side effects. You will not receive a higher dose than the dose level that you are first assigned.
Study Drug Administration:
Dose Escalation and Expansion Groups:
On Day 1 of each 28-day cycle, you will receive carboplatin by vein over 2 hours.
Starting on Day 1 of Cycle 1, you will begin taking trientine by mouth several times each day. If you are in Expansion Group B, you will receive extra doses of trientine within the 14 days before Day 1 of Cycle 1. Your study doctor will tell you when to take trientine and whether it should be taken with or without food. You will also be told how many pills to take.
PK Groups:
Both groups will take the study drugs as described above.
However, if you are in PK Group A, instead of on Day 1 of Cycle 1, you will start taking trientine daily beginning on Day 2 of Cycle 1.
If you are in PK Group B, on Day 21 of Cycle 1 and Day 1 of Cycle 2 you will not eat for 2 hours before and 2 hours after you take trientine.
Study Visits:
Within 7 days before the first dose of study drug:
- You will have a physical exam, including measurement of your weight and vital signs.
- You will be asked how well you are able to perform the normal activities of daily living (performance status).
- Blood (about 2 teaspoons) will be drawn for routine tests.
- Blood (about 1 1/2 tablespoons) will be drawn to measure the levels of ceruloplasmin (copper-carrying protein) copper, and iron in your blood.
- Women who are able to become pregnant must have a negative blood (about 1 teaspoon) pregnancy test.
- If your doctor thinks it is needed, you may have an electrocardiogram (ECG) and/or an echocardiogram (ECHO) to check your heart function. An ECG is a test that measures the electrical activity of the heart
Every week until the doctor decides your are taking the correct dose of trientine:
- Blood (about 1 teaspoon) will be drawn for routine tests.
- Blood (about 2 teaspoons) will be drawn to measure the levels of ceruloplasmin in your blood.
Every week during Cycle 1, blood (about 1 teaspoon) will be drawn for routine tests.
Once each cycle:
- Your medical history will be recorded.
- You will have a physical exam, including measurement of your weight and vital signs.
- Your performance status will be recorded.
- Blood (about 2 teaspoons) will be drawn for routine tests.
- If your study doctor thinks it is needed, blood (about 1 tablespoon) will be drawn to measure levels of copper and iron in your blood.
- You will be asked about any side effects you may be having.
At the end of every 2 cycles (Cycles 2, 4, 6, and so on):
- You will have a CT, MRI, PET scan, and/or x-ray to check the status of the disease.
- If the study doctor thinks it is needed, blood (about 1 teaspoon) will be drawn to measure tumor markers.
PK Groups:
If you are in PK Group A, blood (about 1 teaspoon each time) will be drawn:
- On Day 1 of Cycle 1, blood will be drawn 7 times over the 6 hours after you receive carboplatin.
- On Day 2 of Cycle 1, blood will be drawn 1 time.
- On Day 1 of Cycle 2, blood will be drawn 7 times over the 6 hours after you receive carboplatin.
- On Day 2 of Cycle 2, blood will be drawn 1 time.
If you are in PK Group B, blood (about 1 teaspoon each time) will be drawn:
- On Day 21 of Cycle 1, blood will be drawn 7 times over the 6 hours after your dose of trientine.
- On Day 22 of Cycle 1, will be drawn 1 time.
- On Day 1 of Cycle 2, will be drawn 7 times over the 6 hours after you receive carboplatin.
- On Day 2 of Cycle 2, blood will be drawn 1 time.
Length of Study:
You may continue taking the study drugs for as long as the doctor thinks it is in your best interest. You will be taken off study early if the disease gets worse or you experience intolerable side effects.
Your participation on the study will be over once you have completed the end-of-study visit.
End-of-Study Visit:
Within 30 days after your last dose of study drugs, you will have an end-of-study visit. At this visit, the following tests and procedures performed:
- Your medical history will be recorded.
- You will have a physical exam, including measurement of your weight and vital signs.
- Your performance status will be recorded.
- Blood (about 2 teaspoons) will be drawn for routine tests.
- You will be asked about any side effects you may be experiencing.
- If the study doctor thinks it is needed, blood (about 1 teaspoon) will be drawn to measure tumor markers.
- If the study doctor thinks it is needed, you will have a chest x-ray, CT, MRI, and/or PET scan to check the status of the disease.
This is an investigational study. Trientine is FDA approved and commercially available for the treatment of Wilson's disease. Trientine is not FDA approved for the treatment of advanced cancer. Carboplatin is FDA approved and commercially available for the treatment of ovarian cancer. The combination of trientine and carboplatin to treat advanced cancer is investigational.
Up to 72 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Trientine + Carboplatin MTD Group | Experimental | Drug: Trientine, Drug: CarboplatinTrientine starting dose 750 mg by mouth four times a day, two times with meals and two times without meals for 28 days. Carboplatin maximum tolerated dose found in MTD Dose Escalation Group. |
| MTD Expansion Group | Experimental | Drug: Trientine MTD, Drug: Carboplatin MTDTrientine maximum tolerated dose found in MTD Dose Escalation Group; Carboplatin PK Group A, instead of starting on Day 1 of Cycle 1, starts taking trientine daily beginning on Day 2 of Cycle 1. Trientine PK Group B, 1500 mg of trientine is given once without food on Day 21 of Cycle 1 and once without food after the completion of carboplatin on Day 1 of Cycle 2. Carboplatin maximum tolerated dose found in MTD Dose Escalation Group |
| Carboplatin PK Expansion Group | Experimental | Drug: Trientine MTD, Drug: Carboplatin MTD, Other: PK TestingTrientine maximum tolerated dose found in MTD Dose Escalation Group; Carboplatin PK Group A, instead of starting on Day 1 of Cycle 1, starts taking trientine daily beginning on Day 2 of Cycle 1. Trientine PK Group B, 1500 mg of trientine is given once without food on Day 21 of Cycle 1 and once without food after the completion of carboplatin on Day 1 of Cycle 2. Carboplatin maximum tolerated dose found in MTD Dose Escalation Group. PK testing blood samples of 4 mL at following time points: 0, 30, 60 minutes, 2, 3, 4, 6, and 24 hours. |
| Trientine PK Expansion Group | Experimental | Drug: Trientine MTD, Drug: Carboplatin MTD, Other: PK TestingTrientine maximum tolerated dose found in MTD Dose Escalation Group; Carboplatin PK Group A, instead of starting on Day 1 of Cycle 1, starts taking trientine daily beginning on Day 2 of Cycle 1. Trientine PK Group B, 1500 mg of trientine is given once without food on Day 21 of Cycle 1 and once without food after the completion of carboplatin on Day 1 of Cycle 2. Carboplatin maximum tolerated dose found in MTD Dose Escalation Group. PK testing blood samples of 4 mL at following time points: 0, 30, 60 minutes, 2, 3, 4, 6, and 24 hours. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Patient must have an advanced malignancy that has either failed one or more prior therapies, or for whom there is no established standard of care therapy that prolongs survival by at least 3 months.
- Only in 1 of 3 expansion cohorts, we will plan to enroll 14 subjects with platinum-resistant malignancy. Patient with platinum-resistant malignancy is defined to have had a treatment-free interval of less than 6 months following a platinum-based regimen.
- Patient of any age and any gender. However, those who are 12 years old or younger will be eligible after consultation with their pediatric physicians regarding dose initiation and modification of trientine.
- Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Patient is willing to comply with study procedures and follow-up examinations.
Key exclusion criteria (11 listed)
- Patient receiving any concurrent chemotherapy.
- Underlying medical condition that might be aggravated by treatment or that cannot be controlled, such as active, uncontrolled, serious infection and cardiac dysfunction.
- Medical and/or psychiatric problems of sufficient severity to limit full compliance with the study or expose patients to undue risk.
- Known anaphylactic or severe hypersensitivity to study drugs or their analogs.
- Patient has failed to recover from any prior surgery within 4 weeks of study entry.
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 |
|---|---|---|
| TrientineStarting dose 750 mg by mouth four times a day, two times with meals and two times without meals for 28 days. | Drug | Trientine + Carboplatin MTD Group |
| CarboplatinAlso: ParaplatinStarting dose area under curve (AUC) 4 by vein over two hours on day 1, and once every 28 days. | Drug | Trientine + Carboplatin MTD Group |
| Trientine MTDMaximum tolerated dose found in MTD Dose Escalation Group; Carboplatin PK Group A, instead of starting on Day 1 of Cycle 1, starts taking trientine daily beginning on Day 2 of Cycle 1. Trientine PK Group B, 1500 mg of trientine is given once without food on Day 21 of Cycle 1 and once without food after the completion of carboplatin on Day 1 of Cycle 2. | Drug | Carboplatin PK Expansion Group, MTD Expansion Group, Trientine PK Expansion Group |
| Carboplatin MTDAlso: ParaplatinMaximum tolerated dose found in MTD Dose Escalation Group | Drug | Carboplatin PK Expansion Group, MTD Expansion Group, Trientine PK Expansion Group |
| PK TestingBlood samples of 4 mL at following time points: 0, 30, 60 minutes, 2, 3, 4, 6, and 24 hours. | Other | Carboplatin PK Expansion Group, Trientine PK Expansion Group |
Primary outcome
Maximum Tolerated Dose (MTD) of Carboplatin with Trientine
Time frame: 4 weeks
MTD defined by dose limiting toxicities (DLTs) that occur in the first cycle (4 weeks). DLT defined as treatment-related grade 3 or greater nonhematological toxicity other than nausea, vomiting, or fatigue.
1 secondary outcome
Treatment Response of Maximum Tolerated Dose (MTD) of Carboplatin with Trientine
Time frame: After 2, 28 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 18 Nov 2015.
- Derived from this study: PubMed 22491798Fu S, Naing A, Fu C, Kuo MT, Kurzrock R. Overcoming platinum resistance through the use of a copper-lowering agent. Mol Cancer Ther. 2012 Jun;11(6):1221-5. doi: 10.1158/1535-7163.MCT-11-0864. Epub 2012 Apr 5.
- 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
UT MD Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Trientine, Carboplatin and Trientine MTD in people with Advanced Cancers, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) of Carboplatin with Trientine (time frame: 4 weeks). 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 NCT01178112, 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 18 Nov 2015.