Solid TumorPhase 1/2NCT00354523
Imatinib in Combination With Dacarbazine and Capecitabine in Medullary Thyroid Carcinoma
A Phase 1/2 study testing Capecitabine (Xeloda), DTIC-Dome (Dacarbazine) and Gleevec (Imatinib Mesylate) in people with Solid Tumor and Thyroid Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Objectives: Primary objectives: To determine the maximum tolerated doses (MTD) for the combination of imatinib mesylate, capecitabine, and dacarbazine in patients with solid tumors. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Solid Tumor, Thyroid Cancer
- What is being tested?
- Capecitabine (Xeloda), DTIC-Dome (Dacarbazine) and Gleevec (Imatinib Mesylate)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2004to Aug 2013
- Phase
- Phase 1/2
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age greater than 16 years old.
- Signed informed consent.
- During the phase I portion of the trial, any patient with a proven solid tumor for which no curative or standard treatment is available is eligible. However, for the phase II portion of the trial, patients are required to have medullary thyroid carcinoma that is unresectable or metastatic.
- For the phase I portion of the protocol, there is no limit to the amount of prior therapy participants may have received. For the phase II portion of the trial, 0-1 prior regimens are allowed.
- ECOG performance status must be 0-2.
- Adequate hepatic, renal, and bone marrow function: Absolute neutrophil count greater than/equal to 1,500/uL; platelets greater than/equal to 100,000/uL; total bilirubin less than/equal to 1.5 X institution upper limits of normal (ULN); AST (SGOT)/ALT (SGPT) less than/equal to 2.5 X institutional ULN; Creatinine less than/equal to 1.5 mg/dL
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- Female patients of childbearing potential must have a negative pregnancy test within 7 days before initiation of study drug dosing. Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug.
- Patients may have received prior radiation treatment but the last fraction of radiation treatment must have been completed at least 4 weeks prior to entry on this study.
- Patients may have been treated with surgery but the surgical intervention must have been done at least 3 weeks prior to entry on this study.
- In the phase I part of the trial, measurable disease is not required. Radiographic and measurable evidence of disease is required for the phase II part of the trial. To be considered evaluable for complete or partial response, patients must have at least one measurable lesion as per the modified RECIST Criteria. If radiation was previously received, measurable disease must occur outside the previous radiation field, unless disease progression has been documented.
- Both men and women and members of all ethnic groups are eligible for this trial.
Who cannot join
- In previously treated patients, patients should not have received prior dacarbazine, imatinib mesylate, 5-fluorouracil, or capecitabine. This requirement does not apply to the phase I patients.
- Uncontrolled intercurrent illness including, but not limited to, active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmias not well controlled with medication, myocardial infarction within the previous 6 months, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients who have had chemotherapy within 3 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 28 days earlier.
- Patients may not be receiving any other investigational agents, or have participated in any investigational drug study within 28 days preceding start of study treatment.
- The teratogenic potential of this combination is currently unknown. Women who are pregnant or lactating are excluded.
- History of any other malignancy in the last 5 years, except that patients with a prior history of in situ cancer or basal or squamous cell skin cancer are eligible. Patients with treated disease processes believed to be associated with MEN2, such as pheochromocytomas and primary hyperparathyroidism are allowed in the study.
- Concomitant use of warfarin is not allowed. Low molecular weight and standard heparin use is allowed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I/II Study to Evaluate the Efficacy and Toxicity of Imatinib Mesylate in Combination With Dacarbazine and Capecitabine in Medullary Thyroid Carcinoma
Objectives:
Primary objectives:
To determine the maximum tolerated doses (MTD) for the combination of imatinib mesylate, capecitabine, and dacarbazine in patients with solid tumors.
To determine the overall tumor response rate to imatinib mesylate in combination with capecitabine and dacarbazine as first line and second line therapy in advanced metastatic medullary thyroid carcinoma.
To determine the tolerability (toxicity) of this regimen.
Secondary objectives:
To determine the median overall survival (OS) and time to progression (TTP) for patients treated with this combination.
Read the detailed description
Phase I:
Imatinib mesylate is a drug that binds to certain proteins on the tumor cells, which may prevent the cells from growing. Capecitabine and dacarbazine are drugs that interfere with the growth of cancer cells.
If you are found to be eligible to take part in this study, you will begin treatment with imatinib mesylate, capecitabine, and dacarbazine.
You will come to M. D. Anderson at least once every three weeks (21 days) for treatment. Each 21-day period of treatment is called a "cycle" of therapy. You will receive at least 3 cycles of therapy (9 weeks) unless side effects are severe or the cancer grows very quickly.
The first group of study participants will receive lower doses of imatinib mesylate, capecitabine and dacarbazine. If these doses appear to be safe, the next group of participants will receive higher doses. This will continue until the highest doses that may be safely given are found.
You will take imatinib mesylate capsules by mouth once a day on Days 1-21 of each cycle. Imatinib mesylate should be taken with a meal with a large glass of water.
You will take capecitabine tablets by mouth twice a day on Days 1-14 of each cycle. You should take each dose of capecitabine within 30 minutes after eating a meal. It is important to take the tablets together with water and not fruit juices. Each dose of capecitabine should be about 12 hours apart (for example, after breakfast and after your evening meal).
You will have a small tube (central venous line) inserted into a large vein under the skin of the chest or through a vein in the arm to receive dacarbazine. Dacarbazine will be given over 1 hour on Days 1-3 of each cycle.
During the first cycle of therapy, blood (about 2 ½ teaspoons) will be collected once a week for routine tests. Before each new cycle of therapy, you will have a complete physical exam and urine and blood (about 2 ½ teaspoons) will be collected for routine tests. You will be asked to tell the study doctor about all medications you have taken since you started taking the study drugs and any health problems that you may have experienced. You will also have either CT scans or a MRI of the tumor(s) every 9 weeks and at the end of the study. Additional tests may be done during the study if your doctor feels it is necessary for your care. All tests before each new cycle of treatment and when treatment stops must be done at M. D. Anderson.
You should always tell the study doctor if you are taking any other medication, if you have seen another doctor, if you have received new treatments or if there is any change in the way you are feeling since the last visit. If you are seeing another doctor(s), you should inform these doctors that you are currently in this study. Have the doctor contact the study doctor to discuss any other necessary treatments.
If you experience severe side effects, treatment may be delayed, stopped, or you may receive smaller doses of the drugs. You may continue to receive treatment on this study until the disease gets worse or you experience any intolerable side effects. If this happens, you will be taken off the study and your doctor will discuss other treatment options with you.
When you stop taking part in the study, you will have blood (about 3 teaspoons) collected for routine tests. You will have a physical exam and either a CT scan or a MRI to check on the status of the disease. You will be contacted by phone every three months for the rest of your life to check on the status of the disease and on any symptoms you may be experiencing.
This is an investigational study. The drugs dacarbazine, imatinib mesylate, and capecitabine are FDA approved and commercially available for treating certain forms of cancer. Up to 24 participants will take part in this study. All will be enrolled at M. D. Anderson.
Phase II:
Imatinib mesylate is a drug that binds to certain proteins on the tumor cells, which may prevent the cells from growing. Capecitabine and dacarbazine are drugs that interfere with the growth of cancer cells.
If you are found to be eligible to take part in this study, you will begin treatment with imatinib mesylate, capecitabine, and dacarbazine.
You will come to M. D. Anderson at least once every three weeks (21 days) for treatment. Each 21-day period of treatment is called a "cycle" of therapy. You will receive at least 3 cycles of therapy (9 weeks) unless side effects are severe or the cancer grows very quickly.
You will take imatinib mesylate capsules by mouth once a day on Days 1-21 of each cycle. Imatinib mesylate should be taken with a meal with a large glass of water.
You will take capecitabine tablets by mouth twice a day on Days 1-14 of each cycle. You should take each dose of capecitabine within 30 minutes after eating a meal. It is important to take the tablets together with water and not fruit juices. Each dose of capecitabine should be about 12 hours apart (for example, after breakfast and after your evening meal)
You will have a small tube (central venous line) inserted into a large vein under the skin of the chest or through a vein in the arm to receive dacarbazine. Dacarbazine will be given over 1 hour on Days 1-3 of each cycle.
During the first cycle of therapy, blood (about 2 ½ teaspoons) will be collected once a week for routine tests. Before each new cycle of therapy, you will have a complete physical exam and urine and blood (about 2 ½ teaspoons) will be collected for routine tests. You will be asked to tell the study doctor about all medications you have taken since you started taking the study drugs and any health problems that you may have experienced. You will also have either CT scans or a MRI of the tumor(s) every 9 weeks and at the end of the study. Additional tests may be done during the study if your doctor feels it is necessary for your care. All tests before each new cycle of treatment and when treatment stops must be done at M. D. Anderson.
You should always tell the study doctor if you are taking any other medication, if you have seen another doctor, if you have received new treatments or if there is any change in the way you are feeling since the last visit. If you are seeing another doctor(s), you should inform these doctors that you are currently in this study. Have the doctor contact the study doctor to discuss any other necessary treatments.
If you experience severe side effects, treatment may be delayed, stopped, or you may receive smaller doses of the drugs. You may continue to receive treatment on this study until the disease gets worse or you experience any intolerable side effects. If this happens, you will be taken off the study and your doctor will discuss other treatment options with you.
When you stop taking part in the study, you will have blood (about 3 teaspoons) collected for routine tests. You will have a physical exam and either a CT scan or a MRI to check on the status of the disease. You will be contacted by phone every three months for the rest of your life to check on the status of the disease and on any symptoms you may be experiencing.
This is an investigational study. The drugs dacarbazine, imatinib mesylate, and capecitabine are FDA approved and commercially available for treating other forms of cancer. They are not approved for the treatment of medullary thyroid carcinoma. Up to 28 participants will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Solid Tumor, Thyroid Cancer
- Being tested
- Capecitabine (Xeloda), DTIC-Dome (Dacarbazine), Gleevec (Imatinib Mesylate)
- Keywords
- Solid Tumor, Thyroid Cancer, Medullary Thyroid Cancer, MTC, Advanced Metastatic Medullary Thyroid Carcinoma, Capecitabine, Dacarbazine, Imatinib, Gleevec, Imatinib Mesylate, DTIC-Dome, Xeloda
- Medical subject headings
- Thyroid Neoplasms, Carcinoma, Medullary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capecitabine (Xeloda)Drug
Starting Dose 500 mg/m^2 twice a day Days 1-14 of 21 Day Cycle.
DTIC-Dome (Dacarbazine)Drug
Starting Dose 250 mg/m^2 a day on Days 1-3 of 21 Day Cycle.
Gleevec (Imatinib Mesylate)Drug
Also called Imatinib
Starting Dose 400 mg a day on Days 1-21 of 21 Day Cycle.
| Study group | Role | What they receive |
|---|---|---|
| Capecitabine + Dacarbazine + Imatinib | Experimental | Capecitabine starting Dose 500 mg/m^2 twice a day Days 1-14 of 21 Day Cycle. Dacarbazine starting Dose 250 mg/m^2 a day on Days 1-3 of 21 Day Cycle. Imatinib starting Dose 400 mg a day on Days 1-21 of 21 Day Cycle. Receives: Drug: Capecitabine (Xeloda); Drug: DTIC-Dome (Dacarbazine); Drug: Gleevec (Imatinib Mesylate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated doses (MTD) for the combination of imatinib mesylate, capecitabine, and dacarbazine
The MTD is defined as the dose level below that producing dose limiting toxicity (DLT; i.e. any Grade 4 hematologic toxicity and /or non hematological toxicity >/= Grade 3 in 2/6 participants).
Measured: 21 day cycle
Secondary outcomes (1)
Objective Response Rate
Objective response rate is defined to be the proportion of participants achieving Complete Response (CR) or Partial Response (PR). Response to treatment will be measured using the RECIST criteria with radiological evaluation every 9 weeks.
Measured: Minimally 9 weeks (overall study period 5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2006 (estimated)
- Study startDec 2004
- Primary completionNov 2006
- Study completionAug 2013
Why it stopped: Study closed following Phase I portion, insufficient activity to continue to Phase II.
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 Solid TumorStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- James Yao, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00354523
- Sponsor's protocol ID
- 2004-0475
- Status last verified
- Dec 2014
- First submitted
- 18 Jul 2006
- Last updated
- 17 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Halperin DM, Phan AT, Hoff AO, Aaron M, Yao JC, Hoff PM. A phase I study of imatinib, dacarbazine, and capecitabine in advanced endocrine cancers. BMC Cancer. 2014 Aug 2;14:561. doi: 10.1186/1471-2407-14-561.
PubMed 25086465
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study to Evaluate the Efficacy and Toxicity of Imatinib Mesylate in Combination With Dacarbazine and Capecitabine in Medullary Thyroid Carcinoma
- ClinicalTrials.gov ID
- NCT00354523
- Acronym / sponsor ID
- 2004-0475
- Conditions
- Solid Tumor, Thyroid Cancer
- Keywords
- Solid Tumor, Thyroid Cancer, Medullary Thyroid Cancer, MTC, Advanced Metastatic Medullary Thyroid Carcinoma, Capecitabine, Dacarbazine, Imatinib
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study closed following Phase I portion, insufficient activity to continue to Phase II.
- Enrolment
- 21 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- Dec 2004
- Primary completion
- Nov 2006 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 20 Jul 2006 (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.
Objectives:
Primary objectives:
To determine the maximum tolerated doses (MTD) for the combination of imatinib mesylate, capecitabine, and dacarbazine in patients with solid tumors.
To determine the overall tumor response rate to imatinib mesylate in combination with capecitabine and dacarbazine as first line and second line therapy in advanced metastatic medullary thyroid carcinoma.
To determine the tolerability (toxicity) of this regimen.
Secondary objectives:
To determine the median overall survival (OS) and time to progression (TTP) for patients treated with this combination.
Detailed description
Phase I:
Imatinib mesylate is a drug that binds to certain proteins on the tumor cells, which may prevent the cells from growing. Capecitabine and dacarbazine are drugs that interfere with the growth of cancer cells.
If you are found to be eligible to take part in this study, you will begin treatment with imatinib mesylate, capecitabine, and dacarbazine.
You will come to M. D. Anderson at least once every three weeks (21 days) for treatment. Each 21-day period of treatment is called a "cycle" of therapy. You will receive at least 3 cycles of therapy (9 weeks) unless side effects are severe or the cancer grows very quickly.
The first group of study participants will receive lower doses of imatinib mesylate, capecitabine and dacarbazine. If these doses appear to be safe, the next group of participants will receive higher doses. This will continue until the highest doses that may be safely given are found.
You will take imatinib mesylate capsules by mouth once a day on Days 1-21 of each cycle. Imatinib mesylate should be taken with a meal with a large glass of water.
You will take capecitabine tablets by mouth twice a day on Days 1-14 of each cycle. You should take each dose of capecitabine within 30 minutes after eating a meal. It is important to take the tablets together with water and not fruit juices. Each dose of capecitabine should be about 12 hours apart (for example, after breakfast and after your evening meal).
You will have a small tube (central venous line) inserted into a large vein under the skin of the chest or through a vein in the arm to receive dacarbazine. Dacarbazine will be given over 1 hour on Days 1-3 of each cycle.
During the first cycle of therapy, blood (about 2 ½ teaspoons) will be collected once a week for routine tests. Before each new cycle of therapy, you will have a complete physical exam and urine and blood (about 2 ½ teaspoons) will be collected for routine tests. You will be asked to tell the study doctor about all medications you have taken since you started taking the study drugs and any health problems that you may have experienced. You will also have either CT scans or a MRI of the tumor(s) every 9 weeks and at the end of the study. Additional tests may be done during the study if your doctor feels it is necessary for your care. All tests before each new cycle of treatment and when treatment stops must be done at M. D. Anderson.
You should always tell the study doctor if you are taking any other medication, if you have seen another doctor, if you have received new treatments or if there is any change in the way you are feeling since the last visit. If you are seeing another doctor(s), you should inform these doctors that you are currently in this study. Have the doctor contact the study doctor to discuss any other necessary treatments.
If you experience severe side effects, treatment may be delayed, stopped, or you may receive smaller doses of the drugs. You may continue to receive treatment on this study until the disease gets worse or you experience any intolerable side effects. If this happens, you will be taken off the study and your doctor will discuss other treatment options with you.
When you stop taking part in the study, you will have blood (about 3 teaspoons) collected for routine tests. You will have a physical exam and either a CT scan or a MRI to check on the status of the disease. You will be contacted by phone every three months for the rest of your life to check on the status of the disease and on any symptoms you may be experiencing.
This is an investigational study. The drugs dacarbazine, imatinib mesylate, and capecitabine are FDA approved and commercially available for treating certain forms of cancer. Up to 24 participants will take part in this study. All will be enrolled at M. D. Anderson.
Phase II:
Imatinib mesylate is a drug that binds to certain proteins on the tumor cells, which may prevent the cells from growing. Capecitabine and dacarbazine are drugs that interfere with the growth of cancer cells.
If you are found to be eligible to take part in this study, you will begin treatment with imatinib mesylate, capecitabine, and dacarbazine.
You will come to M. D. Anderson at least once every three weeks (21 days) for treatment. Each 21-day period of treatment is called a "cycle" of therapy. You will receive at least 3 cycles of therapy (9 weeks) unless side effects are severe or the cancer grows very quickly.
You will take imatinib mesylate capsules by mouth once a day on Days 1-21 of each cycle. Imatinib mesylate should be taken with a meal with a large glass of water.
You will take capecitabine tablets by mouth twice a day on Days 1-14 of each cycle. You should take each dose of capecitabine within 30 minutes after eating a meal. It is important to take the tablets together with water and not fruit juices. Each dose of capecitabine should be about 12 hours apart (for example, after breakfast and after your evening meal)
You will have a small tube (central venous line) inserted into a large vein under the skin of the chest or through a vein in the arm to receive dacarbazine. Dacarbazine will be given over 1 hour on Days 1-3 of each cycle.
During the first cycle of therapy, blood (about 2 ½ teaspoons) will be collected once a week for routine tests. Before each new cycle of therapy, you will have a complete physical exam and urine and blood (about 2 ½ teaspoons) will be collected for routine tests. You will be asked to tell the study doctor about all medications you have taken since you started taking the study drugs and any health problems that you may have experienced. You will also have either CT scans or a MRI of the tumor(s) every 9 weeks and at the end of the study. Additional tests may be done during the study if your doctor feels it is necessary for your care. All tests before each new cycle of treatment and when treatment stops must be done at M. D. Anderson.
You should always tell the study doctor if you are taking any other medication, if you have seen another doctor, if you have received new treatments or if there is any change in the way you are feeling since the last visit. If you are seeing another doctor(s), you should inform these doctors that you are currently in this study. Have the doctor contact the study doctor to discuss any other necessary treatments.
If you experience severe side effects, treatment may be delayed, stopped, or you may receive smaller doses of the drugs. You may continue to receive treatment on this study until the disease gets worse or you experience any intolerable side effects. If this happens, you will be taken off the study and your doctor will discuss other treatment options with you.
When you stop taking part in the study, you will have blood (about 3 teaspoons) collected for routine tests. You will have a physical exam and either a CT scan or a MRI to check on the status of the disease. You will be contacted by phone every three months for the rest of your life to check on the status of the disease and on any symptoms you may be experiencing.
This is an investigational study. The drugs dacarbazine, imatinib mesylate, and capecitabine are FDA approved and commercially available for treating other forms of cancer. They are not approved for the treatment of medullary thyroid carcinoma. Up to 28 participants 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 |
|---|---|---|
| Capecitabine + Dacarbazine + Imatinib | Experimental | Drug: Capecitabine (Xeloda), Drug: DTIC-Dome (Dacarbazine), Drug: Gleevec (Imatinib Mesylate)Capecitabine starting Dose 500 mg/m^2 twice a day Days 1-14 of 21 Day Cycle. Dacarbazine starting Dose 250 mg/m^2 a day on Days 1-3 of 21 Day Cycle. Imatinib starting Dose 400 mg a day on Days 1-21 of 21 Day Cycle. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Age greater than 16 years old.
- Signed informed consent.
- During the phase I portion of the trial, any patient with a proven solid tumor for which no curative or standard treatment is available is eligible. However, for the phase II portion of the trial, patients are required to have medullary thyroid carcinoma that is unresectable or metastatic.
- For the phase I portion of the protocol, there is no limit to the amount of prior therapy participants may have received. For the phase II portion of the trial, 0-1 prior regimens are allowed.
- ECOG performance status must be 0-2.
Key exclusion criteria (7 listed)
- In previously treated patients, patients should not have received prior dacarbazine, imatinib mesylate, 5-fluorouracil, or capecitabine. This requirement does not apply to the phase I patients.
- Uncontrolled intercurrent illness including, but not limited to, active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmias not well controlled with medication, myocardial infarction within the previous 6 months, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients who have had chemotherapy within 3 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 28 days earlier.
- Patients may not be receiving any other investigational agents, or have participated in any investigational drug study within 28 days preceding start of study treatment.
- The teratogenic potential of this combination is currently unknown. Women who are pregnant or lactating are excluded.
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 |
|---|---|---|
| Capecitabine (Xeloda)Starting Dose 500 mg/m^2 twice a day Days 1-14 of 21 Day Cycle. | Drug | Capecitabine + Dacarbazine + Imatinib |
| DTIC-Dome (Dacarbazine)Starting Dose 250 mg/m^2 a day on Days 1-3 of 21 Day Cycle. | Drug | Capecitabine + Dacarbazine + Imatinib |
| Gleevec (Imatinib Mesylate)Also: ImatinibStarting Dose 400 mg a day on Days 1-21 of 21 Day Cycle. | Drug | Capecitabine + Dacarbazine + Imatinib |
Primary outcome
Maximum tolerated doses (MTD) for the combination of imatinib mesylate, capecitabine, and dacarbazine
Time frame: 21 day cycle
The MTD is defined as the dose level below that producing dose limiting toxicity (DLT; i.e. any Grade 4 hematologic toxicity and /or non hematological toxicity >/= Grade 3 in 2/6 participants).
1 secondary outcome
Objective Response Rate
Time frame: Minimally 9 weeks (overall study period 5 years)
Results and safety
The study was stopped early (reason given: Study closed following Phase I portion, insufficient activity to continue to Phase II.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2014.
- Derived from this study: PubMed 25086465Halperin DM, Phan AT, Hoff AO, Aaron M, Yao JC, Hoff PM. A phase I study of imatinib, dacarbazine, and capecitabine in advanced endocrine cancers. BMC Cancer. 2014 Aug 2;14:561. doi: 10.1186/1471-2407-14-561.
- 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.
James Yao, MD 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 1/2 study testing Capecitabine (Xeloda), DTIC-Dome (Dacarbazine) and Gleevec (Imatinib Mesylate) in people with Solid Tumor and Thyroid 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 11 inclusion and 7 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: stopped early, as of the sponsor's last update on 17 Dec 2014. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Study closed following Phase I portion, insufficient activity to continue to Phase II.). Results are not available in the source record.
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 doses (MTD) for the combination of imatinib mesylate, capecitabine, and dacarbazine (time frame: 21 day cycle). 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 NCT00354523, 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 17 Dec 2014.