Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005926
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2000-06-28
Brief Title:
Gemcitabine Herceptin and Radiation to Treat Cancer of the Pancreas
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase II Trial of Gemcitabine Herceptin and Radiation for Regionally Confined Adenocarcinoma of the Pancreas
Status:
COMPLETED
Status Verified Date:
2000-06
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:
This study will examine the safety and effectiveness of the drugs Gemcitabine and Herceptin given in conjunction with radiation therapy for treating patients with cancer of the pancreas Gemcitabine is standard therapy for advanced pancreatic cancer It damages tumor cells and may enhance the effects of radiation therapy Herceptin is a genetically engineered antibody that has prevented some tumors from growing in patients with breast cancer Because breast and pancreatic cancer cells share an characteristic related to how Herceptin works similar HER-2neu receptor proteins it is thought that this drug may also inhibit growth of tumors of the pancreas
Patients with pancreatic cancer may be eligible for this study Candidates will be screened with a physical examination chest X-ray blood tests electrocardiogram and computerized tomography CT scan of the chest abdomen and pelvis They will also have a minor surgical procedure called a laparoscopy to evaluate the extent of their cancer This procedure done under general anesthesia requires an overnight hospital stay A small incision about 1 inch is made in the abdomen and a thin flexible tube with a light and special fibers at the end is inserted into the opening This device called a laparoscope allows the surgeon to see inside the abdominal cavity to evaluate the tumor and also to remove a small piece of tumor tissue for examination
Patients accepted into the study will be assigned to one of two treatment groups according to whether or not their tumor can be removed with surgery Patients will be asked to complete a Quality of Life Evaluation before treatment begins and again at each follow-up visit This 15-minute questionnaire assesses patients feelings their ability to carry out usual activities and the effects of therapy on their general health and well being
Patients in both treatment groups will be given the same chemotherapy on an outpatient basis unless special circumstances require hospitalization Gemcitabine is infused over 30 to 60 minutes through an intravenous catheter IV-a thin plastic tube inserted into an arm vein Herceptin is then given over 30 to 90 minutes through the same IV line Radiation therapy to the abdomen will start the same day after the drugs have been administered and will continue for the next 4 days This treatment cycle-chemotherapy plus 5 days of radiation therapy-will be repeated each week for 6 weeks
Within 6 weeks after the last treatment the patients tumor will be evaluated with a blood test and CT scan of the chest abdomen and pelvis to determine if it can be removed with surgery If so the procedure will be done under general anesthesia and will require a 7- to 10-day hospital stay If the tumor cannot be removed with surgery another biopsy will be taken to evaluate the tumors response to the chemotherapy and radiation treatment
All patients will receive additional chemotherapy beginning 6 weeks after surgery for patients whose tumors were removed or 6 weeks after radiation therapy for patients whose tumors could not be removed Gemcitabine and Herceptin will be given IV once a week for 3 weeks followed by a week of rest This 4-week treatment cycle will be repeated up to six times
After treatment ends patients will be evaluated with CT scans or X-rays and blood tests every 3 to 4 months for the first 2 years and every 6 months thereafter to evaluate disease status
Patients with pancreatic cancer may be eligible for this study Candidates will be screened with a physical examination chest X-ray blood tests electrocardiogram and computerized tomography CT scan of the chest abdomen and pelvis They will also have a minor surgical procedure called a laparoscopy to evaluate the extent of their cancer This procedure done under general anesthesia requires an overnight hospital stay A small incision about 1 inch is made in the abdomen and a thin flexible tube with a light and special fibers at the end is inserted into the opening This device called a laparoscope allows the surgeon to see inside the abdominal cavity to evaluate the tumor and also to remove a small piece of tumor tissue for examination
Patients accepted into the study will be assigned to one of two treatment groups according to whether or not their tumor can be removed with surgery Patients will be asked to complete a Quality of Life Evaluation before treatment begins and again at each follow-up visit This 15-minute questionnaire assesses patients feelings their ability to carry out usual activities and the effects of therapy on their general health and well being
Patients in both treatment groups will be given the same chemotherapy on an outpatient basis unless special circumstances require hospitalization Gemcitabine is infused over 30 to 60 minutes through an intravenous catheter IV-a thin plastic tube inserted into an arm vein Herceptin is then given over 30 to 90 minutes through the same IV line Radiation therapy to the abdomen will start the same day after the drugs have been administered and will continue for the next 4 days This treatment cycle-chemotherapy plus 5 days of radiation therapy-will be repeated each week for 6 weeks
Within 6 weeks after the last treatment the patients tumor will be evaluated with a blood test and CT scan of the chest abdomen and pelvis to determine if it can be removed with surgery If so the procedure will be done under general anesthesia and will require a 7- to 10-day hospital stay If the tumor cannot be removed with surgery another biopsy will be taken to evaluate the tumors response to the chemotherapy and radiation treatment
All patients will receive additional chemotherapy beginning 6 weeks after surgery for patients whose tumors were removed or 6 weeks after radiation therapy for patients whose tumors could not be removed Gemcitabine and Herceptin will be given IV once a week for 3 weeks followed by a week of rest This 4-week treatment cycle will be repeated up to six times
After treatment ends patients will be evaluated with CT scans or X-rays and blood tests every 3 to 4 months for the first 2 years and every 6 months thereafter to evaluate disease status
Detailed Description:
This is a phase II study of gemcitabine and Herceptin given weekly as a bolus infusion administered concurrently with radiotherapy in patients with regionally confined resectable or unresectable adenocarcinoma of the pancreas that overexpress HER2 Patients will be treated with external beam radiation in a standard manner over 6 weeks prior to surgical exploration Gemcitabine and Herceptin will be administered on the first day of irradiation and weekly during the course of radiotherapy Patients will be assessed for resectability after treatment and may undergo a pancreatic resection Patients will then be treated with once weekly gemcitabine and herceptin for three weeks followed by 1 week of rest for up to 6 months Patients will be assessed clinically for toxicity tumor response progression-free survival and overall survival
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 00-C-0161 | None | None | None |