A Modular Phase I-II Trial of Lenalidomide and Paclitaxel in Men With Castration-Resistant Prostate Cancer and Lymph-Node Dominant Metastases
Study Drugs:
Lenalidomide is a drug that changes the immune system and it may also interfere with the
development of tiny blood vessels that help support tumor growth. Taking lenalidomide could
prevent the growth of cancer cells.
Paclitaxel is designed to disrupt the growth of cancer cells, which may cause cancer cells
to die.
Phases I and II:
If you are found to be eligible to take part in this study, you will be assigned to a study
group based on when you joined the study. Up to 10 groups of 3 participants will be
enrolled in the Phase I portion of the study, and 1 group of up to 42 participants will be
enrolled in Phase II.
If you are enrolled in the Phase I portion, the doses of lenalidomide you receive will
depend on when you joined this study. The dose of paclitaxel will be the same for all
patients. Up to 5 dose levels of lenalidomide will be tested in the Phase I portion. The
first group of Phase I participants will receive the lower doses of lenalidomide. Each new
group enrolled will receive the higher doses, if no intolerable side effects were seen.
Groups will continue being enrolled (up to 10) until the highest tolerable dose of
lenalidomide (in combination with paclitaxel) is found.
If you are enrolled in the Phase II portion, you will receive lenalidomide at the highest
dose that was tolerated in the Phase I portion in combination with paclitaxel.
Study Drug Administration:
Once you are assigned a dose, you will take lenalidomide capsules by mouth once a day for 21
days in a row, followed by 7 days of rest (Days 22-28). This will be called the "lead-in"
period."
You will the begin taking lenalidomide and paclitaxel on 28 day study cycles. You will take
lenalidomide by mouth every day on Days 1-21 of each cycle. Paclitaxel will be given by
vein over 1 hour on Days 1, 8, and 15 of each cycle. On Days 22-28 of each cycle, you will
take no study drugs. The Day 1 dose of Lenalidomide in each combination cycle may occur
within +/- 5 days of the Day 1 paclitaxel dose.
You should swallow lenalidomide capsules whole with water at the same time each day. Do not
break, chew, or open the capsules.
If you miss a dose of lenalidomide, take it as soon as you remember on the same day.
If you miss taking your dose for the entire day, take your regular dose the next scheduled
day (do NOT take double your regular dose to make up for the missed dose).
If you take more than the prescribed dose of lenalidomide you should seek emergency medical
care, if needed, and contact study staff right away.
Females of childbearing potential that might be caring for you should not touch the
lenalidomide capsules or bottles unless they are wearing gloves.
In order to participate in this study you must also register into and follow the
requirements of the RevAssist® program of Celgene Corporation. This program provides
education and counseling on the risks of fetal exposure, blood clots, and reduced blood
counts. You will be required to receive counseling every 28 days during treatment with
lenalidomide, follow the birth control requirements of the program that are appropriate for
you, and take telephone surveys about your compliance with the program.
Study Visits:
On Day 1 of each cycle (before you receive paclitaxel), the following tests and procedures
will be performed:
- You will have a physical exam, including measurement of your weight.
- Your performance status will be recorded.
- You will be asked about any drugs or treatments you may be receiving.
- Blood (about 2-3 teaspoons) will be drawn for routine tests and tests of your PSA and
testosterone levels.
- You will be asked about any side effects you may have experienced since your last
visit.
On Days 8 and 15 of each cycle (before you receive paclitaxel), the following tests and
procedures will be performed:
- Your weight will be measured.
- Blood (about 2 teaspoons) will be drawn for routine tests.
On Day 1 of Cycle 3 and every 2 cycles thereafter, you will have the following tests and
procedures performed:
- You will have a chest x-ray and a CT scan of your abdomen and pelvis to check the
status of the disease.
- Blood (about 2 teaspoons) will be drawn to test your testosterone level and your liver
function.
- You will have a bone scan to check the status of the disease.
- You will have an ECG.
If you are being treated with paclitaxel at your local oncologist's office, you are only
required to return to M. D. Anderson on Days 1 and 15 of Cycle 1 and on Day 1 of each cycle
after that. All other study visits may be done at your local oncologist's office.
Length of Study:
You will continue on this study as long as you are benefiting. You will be removed from the
study if you experience intolerable side effects, if the disease gets worse, or if the study
doctor thinks it is in your best interest.
End-of-Study Visit:
Once you are off study, the following tests and procedures will be performed:
- You will have a physical exam.
- Blood (about 3-4 teaspoons) will be drawn for routine tests and tests of your PSA and
testosterone levels.
- You will be asked about any side effects you may have experienced since your last
visit.
- Your performance status will be recorded.
This is an investigational study. Lenalidomide is approved by the Food and Drug
Administration (FDA) and commercially available for the treatment of specific types of
myelodysplastic syndrome (MDS) and in combination with dexamethasone for patients with
multiple myeloma (MM) who have received at least 1 prior therapy. Paclitaxel is FDA-approved
and commercially available for the treatment of bladder cancer, lung cancer, breast cancer,
and pancreatic cancer. The use of these drugs in combination is investigational.
Up to 72 participants will take part in this study. All will be enrolled at M. D. Anderson.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose (MTD)
Day 1, Days 8 and 15 of each cycle before Paclitaxel, then Day 1 of Cycle 3 and every 2 cycles thereafter
Yes
Lance Pagliaro, MD
Study Chair
UT MD Anderson Cancer Center
United States: Institutional Review Board
2008-0606
NCT00933426
August 2009
Name | Location |
---|---|
UT MD Anderson Cancer Center | Houston, Texas 77030 |