Spots Global Cancer Trial Database for Gemcitabine and Dasatinib in Advanced Solid Tumors

Study Description

Brief Summary: The goal of this clinical research study is to find the highest tolerable dose of dasatinib in combination with gemcitabine that can be given to patients with advanced solid tumors. The safety of this combination of study drugs will also be studied. Researchers also want to study the pharmacodynamics (PDs) of this study drug combination. PD testing is used to learn what effect the drugs have on your tumors.

Detailed Description: Dasatinib is designed to block several proteins that have been shown to be important for the growth, spreading, and survival of cancers cells. Gemcitabine is designed to disrupt the growth of cancer cells, which may cause them to die and prevent further growth of cancer cells. The amount of dasatinib and gemcitabine that you receive will depend on when you start on this study. There will be 3 participants enrolled in each group. The first group of participants enrolled on this study will be given small doses of dasatinib and gemcitabine. If no intolerable side effects are experienced, the next group of participants will be enrolled at a higher dose level. This process will continue until researchers find the highest tolerable dose of dasatinib and gemcitabine that can be given without intolerable side effects occurring. Up to 15 more patients will be enrolled at this highest tolerable dose in an expansion group. If you are enrolled in the expansion group, you will have a biopsy for PD testing prior to your first day on the study. Your doctor will tell you which group you are enrolled in. Your study doctor will tell you what dose of dasatinib and gemcitabine you will be receiving and how it compares to the doses other participants have received. While on study, your dose may be increased to the next higher level, if the next higher dose level has already been tested in other participants and found to be tolerable. You will take dasatinib by mouth once a day for 7 days in a row before you begin receiving gemcitabine by vein. If no intolerable side effects from dasatinib occur, you will continue taking it for the rest of the study. If you are enrolled in an expansion group, you will take dasatinib by mouth once a day for 56 days in a row. If the disease get worse or you experience any intolerable side effects with dasatinib, you will be taken off this study before you begin taking gemcitabine. You will receive gemcitabine by vein over 30 minutes starting on Day 8. The first cycle is 9 weeks long (63 days). You will receive gemcitabine by vein over 30 minutes once a week for 7 weeks on Days 8, 15, 22, 29, 36, 43, and 50. On Days 51-63, you will not receive any gemcitabine (a rest period for this drug), but you will continue to take dasatinib once a day. There will not be a rest period for dasatinib. If you are enrolled in an expansion group, you will receive gemcitabine by vein over 30 minutes starting on Day 1. The first cycle is 8 weeks long (56 days). You will receive gemcitabine by vein over 30 minutes once a week for 7 weeks on Days 1, 8, 15, 22, 29, 36 and 43. On Days 44- 56, you will not receive any gemcitabine (a rest period for this drug), but you will continue to take dasatinib once a day. There will not be a rest period for dasatinib. Cycle 2 and all other cycles will equal 28 days. You will continue to take dasatinib once a day. You will receive gemcitabine once a week for 3 weeks on Days 1, 8, and 15. On Days 16-28, you will not receive any gemcitabine, but you will continue to take dasatinib once a day. If you experience any intolerable side effects, you may need to have additional blood drawn (about 2 teaspoons) to monitor your condition. Your dose level may be reduced to stop intolerable side effects from occurring, depending on what the study doctor thinks is best. If the disease gets worse or you continue to experience any intolerable side effects with gemcitabine, you will be taken off this study. You will have blood drawn (about 1 teaspoon each time) for PD testing. In Cycle 1 before your daily dose of dasatinib and gemcitabine, PD blood samples will be drawn 1-4 days before you receive the study drug, on Day 8 (on the day the 1st dose of gemcitabine is given) and at the end of week 4 before your receive the study drug. During Week 4 of Cycle 1 and at the end of Cycle 1, you will have a physical exam, including measurement of your vital signs. You will have blood drawn (about 1 tablespoon) and urine collected (at the end of Cycle 1 only) for routine tests. You will be asked how well you are able to perform the normal activities of daily living (a performance status evaluation) and how you are feeling. You will also be asked about other drugs you may be taking and if you have had any intolerable side effects from the study drugs. On Day 1 of all remaining cycles, you will have a physical exam, including measurement of your vital signs. You will have blood drawn (about 1 teaspoon) for routine tests. You will have a performance status evaluation and be asked how you are feeling. You will also be asked about other drugs you may be taking and if you have had any intolerable side effects from the study drugs. Once your participation has ended on this study for any reason, you will be asked to have an end-of-study visit that should occur about 28 days after the last dose of the study drug. At this visit, you will have a physical exam, including measurement of your vital signs and weight. You will have a performance status evaluation and be asked how you are feeling. Blood (about 1 teaspoon) and urine will be collected for routine tests. You will be asked about other drugs you may be taking, and you will be asked if you have had any intolerable side effects from the study drugs. Women who are able to have children will again have a blood (about 1 teaspoon) pregnancy test. If there are study-related side effects reported at the end-of-study visit, you will continue to have follow-up visits or telephone calls, (which will last about 5-10 minutes each time) at least every 4 weeks, to check if you are still experiencing sides effects and until you no longer experience them. This is an investigational study. Dasatinib and gemcitabine are both FDA approved and commercially available. Their use together in this study is experimental and authorized for use in research only. Up to 63 patients will take part in this study. All will be enrolled at M. D. Anderson.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

Useful links and downloads for this trial