Phase I/II Clinical Trial Combining FUS1-nanoparticles and Erlotinib in Stage IV Lung Cancer
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to a dose
level of DOTAP:Chol-fus1 and erlotinib hydrochloride based on when you join this study. Up
to 4 dose levels of the study drug combination will be tested. Three (3) participants will
be enrolled at each dose level. The first group of participants will receive the first dose
combination level. After this dose is given, the participants will be watched for 3 weeks
to check for any serious side effects at that dose level. If any participants in this first
group have intolerable side effects, 1-2 lower dose combinations of the study drugs may be
tested.
If no intolerable side effects are seen in the first group, the second study group will
receive the next planned dose combination. If no intolerable side effects are seen in this
group, the last dose combination will be tested.
If you are enrolled in the Phase II portion, you will receive the highest study combination
dose that was tolerated in the Phase I portion.
During the Phase II portion of the study, half of the participants will not start receiving
erlotinib hydrochloride until Day 8 of Cycle 1 (+/- 1 day). Every odd-numbered participant
(1, 3, 5, and so on) enrolled in Phase II will receive this delayed schedule for erlotinib
hydrochloride.
Study Drug Administration:
You will receive the drugs dexamethasone and diphenhydramine before each infusion of
DOTAP:Chol-fus1, to try to lower the risk of possible allergic reactions to the study drug.
Dexamethasone will be given by mouth about 24 hours before your dose of DOTAP:Chol-fus1, and
by vein about 30 minutes before the dose. Diphenhydramine will also be given (either by
mouth or as an injection) about 30 minutes before the dose.
DOTAP:Chol-fus1 is given by vein as an infusion over 25-35 minutes, on Day 1 of every 3-week
study cycle.
You will take erlotinib hydrochloride by mouth in tablet form every day you are on study
(except for first week of Cycle 1, if you are enrolled in the Phase II delayed-schedule
group).
Erlotinib hydrochloride tablets should be taken at about the same time each day. Each
erlotinib dose should be taken with about 8 ounces of water, and should be taken 1 hour
before or 2 hours after meals. The whole dose must be taken at one time. If you vomit
after taking the tablet(s), you should only re-take the dose if the tablet(s) can still be
seen and counted.
Study Tests:
Each study cycle is 3 weeks.
On Day 1 of each cycle:
- Your vital signs (blood pressure, heart rate, temperature, and breathing rate) will be
measured.
- Urine will be collected for routine tests.
- You will have a test to measure the level of oxygen in your blood.
On Day 1 of Cycle 1 only, blood (about 4 tablespoons total) will be drawn before your first
dose of DOTAP:Chol-fus1 and then about 24 hours later (+/- 4 hours), for research tests to
check your immune system.
On Day 2 of each cycle:
- Blood (about 2 teaspoons) will be drawn for routine tests and tests to check your
immune system.
- Your vital signs will be recorded, and you will be asked about any side effects you may
have.
On Day 7 of Cycle 1, you will have a tumor biopsy for genetic research tests.
On Day 21 of each cycle:
- You will have a physical exam, including measurement of your vital signs.
- Your medical history will be recorded, and you will be asked about any side effects you
may be having.
- Blood (about 2 teaspoons) and urine will be collected for routine tests.
On Day 21 of every other cycle (Cycles 2, 4, 6, and so on), you will have either a chest CT
or PET/CT scan to check the status of the disease. Other scans may be performed, if your
doctor thinks they are needed.
PK Testing:
If you are in Phase 1 and are one of the first 6 participants to be enrolled on this study,
blood (about 2 teaspoons each time) will be drawn for pharmacokinetic (PK) testing. PK
testing measures the amount of study drug in the body at different time points. PK samples
will be drawn during Cycle 1, at the following times:
- Day 1--before the dose of DOTAP:Chol-fus1, at 15 and 30 minutes after the dose, and
then 1, 3, and 6 hours after the dose
- Day 2
- Day 4
- Day 8
- Day 15
Length of Treatment:
You may continue taking the study drug for as long as the doctor thinks it is in your best
interest. You will no longer be able to take the study drug if the disease gets worse,
intolerable side effects occur, or you are unable to follow study directions.
End-of-Treatment Visit:
About 3 weeks after your last dose of DOTAP:Chol-fus1, you will be asked to return to the
clinic for an end-of-treatment visit.
- You will have a physical exam, including measurement of your vital signs.
- Your medical history will be recorded, and you will be asked about any side effects you
may be having.
- Blood (about 2 teaspoons) and urine will be collected for routine tests.
- You will have either a chest CT or PET/CT scan to check the status of the disease.
Long-Term Follow-up:
You will be called by the study staff every 3 months after you stop taking the study drugs.
The study staff will ask you questions to find out how you are doing and to collect
information on any other therapies you have received for cancer. The call should take about
15 minutes.
This is an investigational study. Erlotinib hydrochloride is commercially available and FDA
approved for the treatment of non-small-cell lung cancer. At this time, DOTAP:Chol-fus1 is
only being used in research.
Up to 57 patients will take part in this study. All will be enrolled at MD Anderson.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose (MTD) Level for Drug Treatment Combination
MTD defined as dose level at which less than 2 participants experience dose-limiting toxicity (DLT). Toxicity graded according to National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Version 4. DLT will be grade > 3 toxicity occurring during the first cycle of therapy (i.e., within the first 3 weeks).
First 21 day cycle
Yes
Charles Lu, MD
Principal Investigator
UT MD Anderson Cancer Center
United States: Food and Drug Administration
2011-0432
NCT01455389
September 2013
Name | Location |
---|---|
UT MD Anderson Cancer Center | Houston, Texas 77030 |