Phase II Trial of Pemetrexed Plus Gemcitabine in Patients With Advanced Non-Clear Cell Renal Cell Cancer
Pemetrexed is a chemotherapy drug that is used to treat cancer. It is given intravenously
(by IV--through a vein in your arm). It interferes with cell reproduction.
Gemcitabine is a cancer-fighting (chemotherapy) drug that is given by IV. It interferes
with the growth of cells and is used to treat cancer.
Dexamethasone has many different medical uses. It is used to treat cancer, nausea, vomiting,
inflammation, allergic reactions, and many other conditions. In this study, it is being
given to prevent rashes.
Folic acid and Vitamin B12 are vitamins given to prevent serious side effects which can
occur with chemotherapy. These side effects include diarrhea and a decrease in you red
blood cells, white blood cells, and your blood platelets.
You will be required to take folic acid and vitamin B12. You will take folic acid, by
mouth, daily beginning about 1 week before the first dose of Pemetrexed. You will continue
to take it daily until 3 weeks after the last dose of chemotherapy. Vitamin B12 will be
given as an injection into your muscle about 1 to 2 weeks before your first dose of
Pemetrexed. You will have injections of vitamin B12 about every 9 weeks until 3 weeks after
your last dose of chemotherapy.
During treatment, you will be given Pemetrexed by IV for 10 minutes, followed by Gemcitabine
by IV for 30 minutes on Day 1 of each 2-week study "cycle."
You will take Dexamethasone tablets by mouth, 2 times a day on the day before, the day of,
and the day after each dose of Pemetrexed. Dexamethasone is taken to prevent rashes. If you
could not or did not take Dexamethasone the day before and/or the day of Pemetrexed, you may
be given Dexamethasone by IV over 20 minutes, 30 minutes before the infusion of Pemetrexed.
You will have blood samples (about 4 teaspoons) drawn every week to test your bone marrow.
You will have blood samples (about 1 teaspoon) drawn every 2 weeks to make sure that your
kidneys and liver are working well. You will have a physical exam every 2 weeks before you
receive chemotherapy. You will also be asked about any medications you have been taking
since your last visit.
Once every 8 weeks or after 4 cycles of treatment, you will have the tumor(s) measured using
standard of care imaging which may include a CT scan, MRI, or a bone scan.
You will be treated for as long as you are benefiting from the therapy. You will continue
to receive treatment unless your tumor grows, intolerable side effects occur, or you develop
another illness that prevents you from continuing with the therapy. You may also be taken
off study if you fail to comply with the study requirements. If you are taken off study for
any reason, you and your doctor will discuss other treatment options at that time.
If you are taken off study, you will be asked to have the same scans as before, a physical
exam, and routine blood (about 4 teaspoons). You will be contacted every 3 months after
being off study, to get an update on your health status.
This is an investigational study. Pemetrexed and Gemcitabine are FDA approved and
commercially available. About 40 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
Number of participants with complete or partial response. Response Evaluation Criteria in Solid Tumors (RECIST) of Complete Response: disappearance all target lesions; Partial Response: >30% decrease in sum of longest diameter (LD) of target lesions, reference baseline sum LD; Progressive Disease: >20% increase sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of 1 or > new lesions; Stable Disease: Insufficient shrinkage for partial response, or insufficient increase for progressive disease, reference smallest sum LD since treatment started.
Baseline to 8 weeks (after 4 cycles) protocol response at 16 weeks
Nizar M. Tannir, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
|UT MD . Anderson Cancer Center||Houston, Texas 77030|