Solid Tumors Clinical Trial
Official title:
Phase I Open-Labeled Trial of Gemcitabine and Dasatinib in Advanced Solid Tumors
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.
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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