A Phase II Study of (Neoadjuvant Chemotherapy Trial Prior to Extirpative Surgery) for Clinical Stage TanyN2-3M0 Squamous Cell Carcinoma of the Penis
Before treatment starts, participants will have a complete exam, including blood and urine
tests. A CT scan of the abdomen and pelvis will be done. Participants will have a chest
x-ray, bone scan, and an EKG (heart test). A special heart function test may also need to
be done in some participants. If necessary a biopsy of enlarged lymph node(s) will be
obtained prior to treatment.
Blood tests will be repeated once a week during treatment. CT scans of the abdomen and
pelvis and a Chest x-ray will be done after 2 treatments with Taxol, Ifosfamide, and
Cisplatin. These will also be done before surgery.
The drugs Taxol, Ifosfamide and Cisplatin will be given through a catheter (plastic tube)
placed in a vein in the arm or under the collarbone. Taxol will be given over 3 hours the
first day of the treatment cycle. To prevent an allergic reaction, before the Taxol is
given, the participant will receive three drugs. These are Dexamethasone, Diphenhydramine,
and either Cimetidine or Ranitidine.
After Taxol, Ifosfamide will be given over 2 hours every day for the first three days of the
treatment cycle. To prevent possible irritation of Ifosfamide to the bladder, participants
will also receive Mesna through the plastic catheter. Mesna will be given both before and
after Ifosfamide every day. Mesna is not chemotherapy. It is a medication to prevent side
effects of Ifosfamide into the bladder.
Every day for the first three days of the cycle, and after Ifosfamide is given, participants
will also receive Cisplatin through the catheter at a steady rate over 2 hours, along with
Mannitol and salt water to flush the kidneys. This treatment will be given in the hospital
and will require staying in the hospital for 3-4 days. It will be repeated for a total of 4
times; once every 21 days, if the participant has high enough numbers of white blood cells
Participants may be given injections of G-CSF under the skin once a day for up to 7 days
(days 6-12 of the cycle) to bring the white cells up faster after the chemotherapy. This
will also lower the risk of severe infections.
After completing 4 treatments of chemotherapy, participants will have blood and urine tests,
a chest x-ray to learn the response of the tumor to the chemotherapy. They will also have a
CT scan of the abdomen and pelvis. Participants who have a response to the chemotherapy, or
show no sign of new spread of the cancer to other parts of the body, will then have surgery.
Surgery will be done to remove the tumor. The lymph nodes in the groin will be removed.
The pelvic lymph nodes may also need to be removed. How much tissue is removed depends on
how far the tumor has spread. The surgeons will explain the specifics of the surgery in a
separate consent form.
After completion of the treatment, physical exams, CT scans, chest x-rays, blood tests, and
urine tests will be done every 3 months for 2 years. They will then be done every 6 months.
These procedures can be done by a physician at M. D. Anderson or by the participant's own
doctor. If the participant's doctor does it, the information will need to be forwarded to
the doctors at M. D. Anderson. Participants will be expected to come to M. D. Anderson or
to their respective participating urologist/medical oncologist at least once every 6 months
for a check-up.
This is an investigational study. The FDA has approved Taxol, Ifosfamide, Cisplatin, and
Mesna. Up to 40 participants will take part in this study. All will be enrolled at M. D.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants With Pathologic Complete Remission (pCR)
Histopathologic assessment of surgical resection to confirm Pathologoic Complete Remission. Complete remission defined as disappearance of all target lesions.
restaging with second and fourth 21-day cycles followed by surgery
Lance Pagliaro, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
|U.T.M.D. Anderson Cancer Center||Houston, Texas 77030|