Imatinib in Combination With Dacarbazine and Capecitabine in Medullary Thyroid Carcinoma

Solid Tumor Clinical Trial

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

Status Terminated

Clinical 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.

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.

Clinical Trial 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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Solid Tumor
• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

• NCT number: NCT00354523
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: December 2004
• Completion date: August 2013