Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004547
Status:
COMPLETED
Last Update Posted:
2015-11-18
First Post:
2000-02-03
Brief Title:
Treatment of Peritoneal Cancer With Surgery Perfused Heated Cisplatin and Chemotherapy
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Phase II Trial of Continuous Hyperthermic Peritoneal Perfusion CHPP With Cisplatin Plus Early Postoperative Intraperitoneal Paclitaxel and 5-Fluorouracil for Peritoneal Carcinomatosis
Status:
COMPLETED
Status Verified Date:
2015-09
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 test the effectiveness of an experimental treatment for peritoneal cancer involving surgical removal of the tumor perfusion of the abdomen during surgery with a heated solution of the drug cisplatin and post-surgery combination chemotherapy in the abdomen with fluorouracil 5-FU and paclitaxel
Patients with certain peritoneal cancer whose tumors are confined to the abdomen may be eligible for this study Candidates are screened with a medical history and physical examination including blood tests electrocardiogram and possibly bone scan brain magnetic resonance imaging MRI and chest abdomen and pelvic CT scans
Participants undergo surgery to remove as much tumor as possible Part of the intestines pancreas stomach or the entire spleen may also be removed if they are affected During surgery after the tumor has been removed two catheters thin plastic tubes are placed in the abdomen A chemotherapy solution containing the anti-cancer drug cisplatin heated to a temperature of about 1086 degrees 10 degrees above normal body temperature is then delivered into the abdomen through one catheter and drained through another During treatment a drug called sodium thiosulfate is given through a vein to reduce the risk of side effects of cisplatin particularly kidney damage After 90 minutes of bathing the abdomen with this solution the drug is rinsed from the abdomen and the catheters removed Another small catheter is then placed and left inside the abdomen with one end coming out through the skin Seven to 12 days after the operation the anti-cancer drugs 5-FU and paclitaxel are given through this catheter
After complete recovery from the surgery the catheter is removed and the patient is discharged from the hospital Clinic visits are scheduled for periodic follow-up examination imaging and tests 3 and 6 months after surgery and every 6 months for up to 5 years as long as the disease does not worsen Patients whose disease progresses are taken off the study and referred back to their local physician or referred for alternative care or other research studies
Patients are also asked to assess how this therapy affects their general health and well being This will require filling out two quality-of-life QOL questionnaires before surgery and again at each follow-up visit after surgery Each questionnaire takes about 15 minutes to complete
Patients with certain peritoneal cancer whose tumors are confined to the abdomen may be eligible for this study Candidates are screened with a medical history and physical examination including blood tests electrocardiogram and possibly bone scan brain magnetic resonance imaging MRI and chest abdomen and pelvic CT scans
Participants undergo surgery to remove as much tumor as possible Part of the intestines pancreas stomach or the entire spleen may also be removed if they are affected During surgery after the tumor has been removed two catheters thin plastic tubes are placed in the abdomen A chemotherapy solution containing the anti-cancer drug cisplatin heated to a temperature of about 1086 degrees 10 degrees above normal body temperature is then delivered into the abdomen through one catheter and drained through another During treatment a drug called sodium thiosulfate is given through a vein to reduce the risk of side effects of cisplatin particularly kidney damage After 90 minutes of bathing the abdomen with this solution the drug is rinsed from the abdomen and the catheters removed Another small catheter is then placed and left inside the abdomen with one end coming out through the skin Seven to 12 days after the operation the anti-cancer drugs 5-FU and paclitaxel are given through this catheter
After complete recovery from the surgery the catheter is removed and the patient is discharged from the hospital Clinic visits are scheduled for periodic follow-up examination imaging and tests 3 and 6 months after surgery and every 6 months for up to 5 years as long as the disease does not worsen Patients whose disease progresses are taken off the study and referred back to their local physician or referred for alternative care or other research studies
Patients are also asked to assess how this therapy affects their general health and well being This will require filling out two quality-of-life QOL questionnaires before surgery and again at each follow-up visit after surgery Each questionnaire takes about 15 minutes to complete
Detailed Description:
Background
Cytoreductive surgery plus aggressive combination intraperitoneal chemotherapy may significantly alter the natural history of peritoneal carcinomatosis The purpose of this study is to examine the treatment results of continuous hyperthermic peritoneal perfusion CHPP with cisplatin plus early postoperative intraperitoneal dwell therapy with 5-FU and paclitaxel after cytoreductive surgery for peritoneal carcinomatosis
Objectives
The primary objective of this study is to determine response and survival after continuous hyperthermic peritoneal perfusion with cisplatin and early postoperative intraperitoneal dwell therapy with 5-FU and paclitaxel Response can only be assessed by measuring the time to clinical or radiographic recurrence of disease
The secondary objectives include the determination of pharmacokinetics of paclitaxel and 5-FU delivered into the peritoneal cavity and the impact that continuous hyperthermic peritoneal perfusion with cisplatin and early postoperative intraperitoneal dwell therapy with 5-FU and paclitaxel has on patients health related quality of life
The evaluation of pure populations of tumor and normal mesothelial cells to
determine if signal transduction pathways are distinct in tumor versus normal tissue
to see if specific cell pathways are activated or inhibited as a consequence of therapy
to validate that this technology can provide informative data about these events as a potential surrogate for clinical benefit from therapy or biological behavior of the tumor
Eligibility
The patient greater than or equal to 30 kg must have histologically proven peritoneal carcinomatosis from one of the following histologies 1 primary peritoneal mesothelioma 2 low grade mucinous adenocarcinoma including low grade mucinous neoplasms of borderline malignant potential 3 adenocarcinoma of gastrointestinal tract origin other than low grade mucinous excluding pancreatic cancer with disease confined to the peritoneal cavity Patients may not have had treatment for their disease within the previous 30 days and have recovered from all toxicity Patients must meet certain safety laboratory criteria and may not have major medical disorders that would place them at unacceptable risk for a major surgical procedure Patients may not have received prior intraperitoneal platinum therapy
Design
Patients will undergo cytoreductive surgery followed by CHPP with cisplatin A peritoneal dialysis catheter will be inserted into the peritoneal cavity at the time of laparotomy In the early postoperative period day 2 - 10 intraperitoneal dwell chemotherapy with paclitaxel 125 mgM2 and 5-FU 800 mgM2 will be administered Patients will be seen 4 - 6 weeks after discharge for a physical examination and laboratory screen and QOL evaluation Tumor marker will be included at this stage Patients will then be seen every 3 months for the first year after surgery and every 6 months thereafter At each visit they will undergo physical examination laboratory screening including tumor marker and a CT scan of the chest abdomen and pelvis and QOL evaluation
The objective of this pilot study is to estimate the ability of peritoneal perfusion to achieve potentially tolerable disease free survival in patients with a variety of tumors For each class of tumors an appropriate distinct median disease free survival will be targeted as the principal endpoint The trial will be conducted as a set of three single-stage phase II studies with an early stopping rule for clearly unacceptable outcomes It is expected that accrual for 59 patients with adenocarcinoma of gastrointestinal origin other than low grade mucinous 48 patients with low grade mucinous adenocarcinoma and 96 patients with primary peritoneal mesothelioma total accrual of 203 will require approximately 5 -6 years
Results will be assessed by following the time to radiographic or clinical recurrence of disease and survival Patients will be stratified for entry based on histology This will include 3 cohorts 1 peritoneal mesothelioma 2 low grade mucinous adenocarcinoma including low grade mucinous neoplasms of borderline malignant potential and 3 adenocarcinoma of gastrointestinal origin other than low grade mucinous
Cytoreductive surgery plus aggressive combination intraperitoneal chemotherapy may significantly alter the natural history of peritoneal carcinomatosis The purpose of this study is to examine the treatment results of continuous hyperthermic peritoneal perfusion CHPP with cisplatin plus early postoperative intraperitoneal dwell therapy with 5-FU and paclitaxel after cytoreductive surgery for peritoneal carcinomatosis
Objectives
The primary objective of this study is to determine response and survival after continuous hyperthermic peritoneal perfusion with cisplatin and early postoperative intraperitoneal dwell therapy with 5-FU and paclitaxel Response can only be assessed by measuring the time to clinical or radiographic recurrence of disease
The secondary objectives include the determination of pharmacokinetics of paclitaxel and 5-FU delivered into the peritoneal cavity and the impact that continuous hyperthermic peritoneal perfusion with cisplatin and early postoperative intraperitoneal dwell therapy with 5-FU and paclitaxel has on patients health related quality of life
The evaluation of pure populations of tumor and normal mesothelial cells to
determine if signal transduction pathways are distinct in tumor versus normal tissue
to see if specific cell pathways are activated or inhibited as a consequence of therapy
to validate that this technology can provide informative data about these events as a potential surrogate for clinical benefit from therapy or biological behavior of the tumor
Eligibility
The patient greater than or equal to 30 kg must have histologically proven peritoneal carcinomatosis from one of the following histologies 1 primary peritoneal mesothelioma 2 low grade mucinous adenocarcinoma including low grade mucinous neoplasms of borderline malignant potential 3 adenocarcinoma of gastrointestinal tract origin other than low grade mucinous excluding pancreatic cancer with disease confined to the peritoneal cavity Patients may not have had treatment for their disease within the previous 30 days and have recovered from all toxicity Patients must meet certain safety laboratory criteria and may not have major medical disorders that would place them at unacceptable risk for a major surgical procedure Patients may not have received prior intraperitoneal platinum therapy
Design
Patients will undergo cytoreductive surgery followed by CHPP with cisplatin A peritoneal dialysis catheter will be inserted into the peritoneal cavity at the time of laparotomy In the early postoperative period day 2 - 10 intraperitoneal dwell chemotherapy with paclitaxel 125 mgM2 and 5-FU 800 mgM2 will be administered Patients will be seen 4 - 6 weeks after discharge for a physical examination and laboratory screen and QOL evaluation Tumor marker will be included at this stage Patients will then be seen every 3 months for the first year after surgery and every 6 months thereafter At each visit they will undergo physical examination laboratory screening including tumor marker and a CT scan of the chest abdomen and pelvis and QOL evaluation
The objective of this pilot study is to estimate the ability of peritoneal perfusion to achieve potentially tolerable disease free survival in patients with a variety of tumors For each class of tumors an appropriate distinct median disease free survival will be targeted as the principal endpoint The trial will be conducted as a set of three single-stage phase II studies with an early stopping rule for clearly unacceptable outcomes It is expected that accrual for 59 patients with adenocarcinoma of gastrointestinal origin other than low grade mucinous 48 patients with low grade mucinous adenocarcinoma and 96 patients with primary peritoneal mesothelioma total accrual of 203 will require approximately 5 -6 years
Results will be assessed by following the time to radiographic or clinical recurrence of disease and survival Patients will be stratified for entry based on histology This will include 3 cohorts 1 peritoneal mesothelioma 2 low grade mucinous adenocarcinoma including low grade mucinous neoplasms of borderline malignant potential and 3 adenocarcinoma of gastrointestinal origin other than low grade mucinous
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-0069 | None | None | None |