Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00512096
Status:
COMPLETED
Last Update Posted:
2012-08-01
First Post:
2007-08-06
Brief Title:
Neoadjuvant Chemotherapy for Patients With Squamous Cell Carcinoma of the Penis
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase II Study of Neoadjuvant Chemotherapy Trial Prior to Extirpative Surgery for Clinical Stage TanyN2-3M0 Squamous Cell Carcinoma of the Penis
Status:
COMPLETED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary Objective
-To evaluate the feasibility and efficacy of multimodality treatment neoadjuvant chemotherapy prior to extirpative surgery for clinical stage TXN2-3M0 squamous cell carcinoma of the penis
-To evaluate the feasibility and efficacy of multimodality treatment neoadjuvant chemotherapy prior to extirpative surgery for clinical stage TXN2-3M0 squamous cell carcinoma of the penis
Detailed Description:
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 nodes 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 and platelets
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 participants own doctor If the participants 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 urologistmedical 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 Anderson
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 and platelets
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 participants own doctor If the participants 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 urologistmedical 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 Anderson
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None