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Treatment of Peritoneal Cancer With Surgery, Perfused Heated Cisplatin and Chemotherapy

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ClinicalTrials.gov Identifier: NCT00004547
Recruitment Status : Completed
First Posted : February 4, 2000
Results First Posted : November 22, 2011
Last Update Posted : November 18, 2015
Sponsor:
Information provided by (Responsible Party):
Marybeth Hughes, M.D., National Institutes of Health Clinical Center (CC)

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Abdominal Neoplasm
Colonic Neoplasm
Mesothelioma
Peritoneal Neoplasm
Interventions Procedure: Surgery
Procedure: Continuous hyperthermic peritoneal perfusion (CHPP) with Cisplatin
Drug: Postoperative dwell with paclitaxel and 5-FU
Enrollment 188
Recruitment Details A total accrual of 203 was expected within approximately 5-6 years (59 patients for adenocarcinoma of gastrointestinal origin, other than low grade mucinous; 48 patients with low grade mucinous adenocarcinoma; and 96 patients with primary peritoneal mesothelioma).
Pre-assignment Details  
Arm/Group Title Peritoneal Mesothelioma Low Grade Mucinous Adenocarcinoma Adenocarcinoma of Gastrointestinal Origin
Hide Arm/Group Description Patients with peritoneal mesothelioma suffer with intractable ascites but have a very surface oriented tumor which usually does not invade into organs and cause organ dysfunction. The main source of symptoms and cause of death is intractable ascites. Low grade mucinous adenocarcinoma also includes low grade mucinous neoplasms of borderline malignant potential. Patients with low grade mucinous adenocarcinoma can have prolonged survival with debulking surgery alone. The majority of patients with truly malignant disease will die of complications from intraperitoneal progression of tumor within 2 to 5 years. The tumors are often surface oriented within the peritoneal cavity without metastases to other distant sites. The most common origin for this type of tumor is the appendix and ovary. Adenocarcinoma of gastrointestinal origin also includes other than low grade mucinous. Aggressive gastrointestinal adenocarcinomas such as gastric, small bowel, and colon cancer , tend to be more invasive into tissues and can more readily metastasize to distant sites. The cause of death is usually directly related to intraperitoneal progression of tumor. It is a more difficult group of patients to treat with intraperitoneal therapy because of the aggressive and invasive nature of the tumors.
Period Title: Overall Study
Started 83 48 57
Not Evaluable 21 9 23
Completed 61 39 35
Not Completed 22 9 22
Arm/Group Title Peritoneal Mesothelioma Low Grade Mucinous Adenocarcinoma Adenocarcinoma of Gastrointestinal Origin Total
Hide Arm/Group Description Patients with peritoneal mesothelioma suffer with intractable ascites but have a very surface oriented tumor which usually does not invade into organs and cause organ dysfunction. The main source of symptoms and cause of death is intractable ascites. Low grade mucinous adenocarcinoma also includes low grade mucinous neoplasms of borderline malignant potential. Patients with low grade mucinous adenocarcinoma can have prolonged survival with debulking surgery alone. The majority of patients with truly malignant disease will die of complications from intraperitoneal progression of tumor within 2 to 5 years. The tumors are often surface oriented within the peritoneal cavity without metastases to other distant sites. The most common origin for this type of tumor is the appendix and ovary. Adenocarcinoma of gastrointestinal origin also includes other than low grade mucinous. Aggressive gastrointestinal adenocarcinomas such as gastric, small bowel, and colon cancer , tend to be more invasive into tissues and can more readily metastasize to distant sites. The cause of death is usually directly related to intraperitoneal progression of tumor. It is a more difficult group of patients to treat with intraperitoneal therapy because of the aggressive and invasive nature of the tumors. Total of all reporting groups
Overall Number of Baseline Participants 83 48 57 188
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 83 participants 48 participants 57 participants 188 participants
<=18 years
3
   3.6%
0
   0.0%
0
   0.0%
3
   1.6%
Between 18 and 65 years
71
  85.5%
43
  89.6%
52
  91.2%
166
  88.3%
>=65 years
9
  10.8%
5
  10.4%
5
   8.8%
19
  10.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 83 participants 48 participants 57 participants 188 participants
49.95  (14.12) 50.48  (10.85) 49.70  (11.78) 50.01  (12.61)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 83 participants 48 participants 57 participants 188 participants
Female
38
  45.8%
23
  47.9%
28
  49.1%
89
  47.3%
Male
45
  54.2%
25
  52.1%
29
  50.9%
99
  52.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 83 participants 48 participants 57 participants 188 participants
White 69 38 54 161
Hispanic 6 0 3 9
African American 2 7 0 9
Asian American 4 3 0 7
Unknown 2 0 0 2
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 83 participants 48 participants 57 participants 188 participants
83 48 57 188
1.Primary Outcome
Title Number of Participants With Disease-free Survival
Hide Description Participants who achieve either a six or twelve month disease free interval based on radiographic imaging and symptoms.
Time Frame On study date until the first scan with imageable disease, assessed up to 100 months or more.
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was not analyzed because information was not consistently available.
Arm/Group Title Peritoneal Mesothelioma Low Grade Mucinous Adenocarcinoma Adenocarcinoma of Gastrointestinal Origin
Hide Arm/Group Description:
Patients with peritoneal mesothelioma suffer with intractable ascites but have a very surface oriented tumor which usually does not invade into organs and cause organ dysfunction. The main source of symptoms and cause of death is intractable ascites.
Low grade mucinous adenocarcinoma also includes low grade mucinous neoplasms of borderline malignant potential. Patients with low grade mucinous adenocarcinoma can have prolonged survival with debulking surgery alone. The majority of patients with truly malignant disease will die of complications from intraperitoneal progression of tumor within 2 to 5 years. The tumors are often surface oriented within the peritoneal cavity without metastases to other distant sites. The most common origin for this type of tumor is the appendix and ovary.
Adenocarcinoma of gastrointestinal origin also includes other than low grade mucinous. Aggressive gastrointestinal adenocarcinomas such as gastric, small bowel, and colon cancer , tend to be more invasive into tissues and can more readily metastasize to distant sites. The cause of death is usually directly related to intraperitoneal progression of tumor. It is a more difficult group of patients to treat with intraperitoneal therapy because of the aggressive and invasive nature of the tumors.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Number of Participants With a Response
Hide Description Response is assessed by measuring the time to clinical or radiographic recurrence of disease. Patients will be followed with computed tomography (CT) scans. At any time point where there is evidence of progressive disease in the peritoneal cavity (imageable tumor nodules or new onset of ascites) the patients will be scored as failing within the abdominal cavity.
Time Frame Patients were assessed every three months for one year and then every 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Peritoneal Mesothelioma Low Grade Mucinous Adenocarcinoma Adenocarcinoma of Gastrointestinal Origin
Hide Arm/Group Description:
Patients with peritoneal mesothelioma suffer with intractable ascites but have a very surface oriented tumor which usually does not invade into organs and cause organ dysfunction. The main source of symptoms and cause of death is intractable ascites.
Low grade mucinous adenocarcinoma also includes low grade mucinous neoplasms of borderline malignant potential. Patients with low grade mucinous adenocarcinoma can have prolonged survival with debulking surgery alone. The majority of patients with truly malignant disease will die of complications from intraperitoneal progression of tumor within 2 to 5 years. The tumors are often surface oriented within the peritoneal cavity without metastases to other distant sites. The most common origin for this type of tumor is the appendix and ovary.
Adenocarcinoma of gastrointestinal origin also includes other than low grade mucinous. Aggressive gastrointestinal adenocarcinomas such as gastric, small bowel, and colon cancer , tend to be more invasive into tissues and can more readily metastasize to distant sites. The cause of death is usually directly related to intraperitoneal progression of tumor. It is a more difficult group of patients to treat with intraperitoneal therapy because of the aggressive and invasive nature of the tumors.
Overall Number of Participants Analyzed 83 48 57
Measure Type: Number
Unit of Measure: Participants
24 18 6
3.Primary Outcome
Title Number of Participants With Adverse Events
Hide Description Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.
Time Frame only assessed during the perioperative period (i.e. up to 90 days following surgery)
Hide Outcome Measure Data
Hide Analysis Population Description
188 participants is consistent with the total number of participants analyzed (e.g. total from each column in participant flow, 83 P. Meso + 48 L. Grade + 57 Adeno. = 188).
Arm/Group Title Mesothelioma, Low Grade, and Adenocarcinoma
Hide Arm/Group Description:
Patients with peritoneal mesothelioma suffer with intractable ascites. Patients with low grade mucinous adenocarcinoma can have prolonged survival with debulking surgery alone. Adenocarcinoma of gastrointestinal origin also includes other than low grade mucinous. Aggressive gastrointestinal adenocarcinomas such as gastric, small bowel, and colon cancer, tend to be more invasive.
Overall Number of Participants Analyzed 188
Measure Type: Number
Unit of Measure: Participants
73
4.Secondary Outcome
Title Percentage of Participants Who Had Paclitaxel and 5-fluorouracil (5-FU) Analysis Performed
Hide Description Paclitaxel and 5-FU levels in plasma and perfusate will be determined by standard high-performance liquid chromatography (HPLC). Samples will be collected just prior to (Time 0) the infusion of the intraperitoneal dwell of 5-FU and paclitaxel, at the following time intervals after the conclusion of the intraperitoneal dwell infusion (15 minutes, 1 hour, 6 hour, 12 hour, 24 hour, 48 hour).
Time Frame Perioperative day 7-12 after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was not analyzed because it was not feasible (e.g. inadequate samples).
Arm/Group Title Peritoneal Mesothelioma Low Grade Mucinous Adenocarcinoma Adenocarcinoma of Gastrointestinal Origin
Hide Arm/Group Description:
Patients with peritoneal mesothelioma suffer with intractable ascites but have a very surface oriented tumor which usually does not invade into organs and cause organ dysfunction. The main source of symptoms and cause of death is intractable ascites.
Low grade mucinous adenocarcinoma also includes low grade mucinous neoplasms of borderline malignant potential. Patients with low grade mucinous adenocarcinoma can have prolonged survival with debulking surgery alone. The majority of patients with truly malignant disease will die of complications from intraperitoneal progression of tumor within 2 to 5 years. The tumors are often surface oriented within the peritoneal cavity without metastases to other distant sites. The most common origin for this type of tumor is the appendix and ovary.
Adenocarcinoma of gastrointestinal origin also includes other than low grade mucinous. Aggressive gastrointestinal adenocarcinomas such as gastric, small bowel, and colon cancer , tend to be more invasive into tissues and can more readily metastasize to distant sites. The cause of death is usually directly related to intraperitoneal progression of tumor. It is a more difficult group of patients to treat with intraperitoneal therapy because of the aggressive and invasive nature of the tumors.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Quality of Life Questionnaire Score
Hide Description

The Short-Form-36 Health Survey (SF-36) and the Functional Assessment of Cancer Therapy Disease Specific for Colorectal Cancer (FACT-C) will be given to the patients upon admission preoperatively, then 6 weeks postoperatively, and then 3, 6, 9, and 12 months for the first year and then every 6 months until the patient goes off study. These forms summarize a participants positive and negative aspects that characterize one's psychological (emotional(, physical, and social well-being at a point in time.

For detailed information about the questionnaires, please see the Protocol Link module.

Time Frame preop, 6 weeks postop and then 3, 6, 9, and 12 months the first year and then every 6 months until the patient is off study
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was not evaluated due to poor patient compliance.
Arm/Group Title Peritoneal Mesothelioma Low Grade Mucinous Adenocarcinoma Adenocarcinoma of Gastrointestinal Origin
Hide Arm/Group Description:
Patients with peritoneal mesothelioma suffer with intractable ascites but have a very surface oriented tumor which usually does not invade into organs and cause organ dysfunction. The main source of symptoms and cause of death is intractable ascites.
Low grade mucinous adenocarcinoma also includes low grade mucinous neoplasms of borderline malignant potential. Patients with low grade mucinous adenocarcinoma can have prolonged survival with debulking surgery alone. The majority of patients with truly malignant disease will die of complications from intraperitoneal progression of tumor within 2 to 5 years. The tumors are often surface oriented within the peritoneal cavity without metastases to other distant sites. The most common origin for this type of tumor is the appendix and ovary.
Adenocarcinoma of gastrointestinal origin also includes other than low grade mucinous. Aggressive gastrointestinal adenocarcinomas such as gastric, small bowel, and colon cancer , tend to be more invasive into tissues and can more readily metastasize to distant sites. The cause of death is usually directly related to intraperitoneal progression of tumor. It is a more difficult group of patients to treat with intraperitoneal therapy because of the aggressive and invasive nature of the tumors.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Signal Transduction Pathways in Tumor Tissue Versus Normal Tissue
Hide Description Signal transduction pathways were measured using reverse phase protein lysate microarray to determine if the pathways are distinct in tumor versus normal tissue.
Time Frame once during surgery
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was not analyzed because it was not feasible.
Arm/Group Title Normal Tissue Tumor Tissue
Hide Arm/Group Description:
Non-diseased tissue
Diseased tissue
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse Events: 188 participants is consistent with the total number of participants analyzed (e.g. total from each column in participant flow, 83 P.Meso + 48 L.Grade + 57 Adeno. = 188).
 
Arm/Group Title Mesothelioma, Low Grade, and Adenocarcinoma
Hide Arm/Group Description Patients with peritoneal mesothelioma suffer with intractable ascites. Patients with low grade mucinous adenocarcinoma can have prolonged survival with debulking surgery alone. Adenocarcinoma of gastrointestinal origin also includes other than low grade mucinous. Aggressive gastrointestinal adenocarcinomas such as gastric, small bowel, and colon cancer, tend to be more invasive.
All-Cause Mortality
Mesothelioma, Low Grade, and Adenocarcinoma
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Mesothelioma, Low Grade, and Adenocarcinoma
Affected / at Risk (%) # Events
Total   71/188 (37.77%)    
Cardiac disorders   
atrial fibrillation  1  1/188 (0.53%)  1
Myocardial infarction  1  1/188 (0.53%)  1
Gastrointestinal disorders   
ascites  1  2/188 (1.06%)  2
colitis  1  1/188 (0.53%)  1
colon perforation  1  2/188 (1.06%)  2
diarrhea  1  1/188 (0.53%)  1
Enterocutaneous fistula  1  2/188 (1.06%)  2
Gastric perforation  1  1/188 (0.53%)  1
Gastrointestinal (GI) perforation  1  1/188 (0.53%)  1
Ileus  1  2/188 (1.06%)  2
Nausea  1  4/188 (2.13%)  4
Pancreatic fistula  1  1/188 (0.53%)  1
Pancreatitis  1  3/188 (1.60%)  3
Perforated bowel  1  1/188 (0.53%)  1
Peritonitis  1  1/188 (0.53%)  1
Small bowel obstruction (sbo)  1  1/188 (0.53%)  1
Small bowel obstruction  1  12/188 (6.38%)  12
Hepatobiliary disorders   
cholecystitis  1  1/188 (0.53%)  1
Thrombosis portal vein  1  1/188 (0.53%)  1
Infections and infestations   
Neutropenic fever  1  5/188 (2.66%)  5
Sepsis  1  1/188 (0.53%)  1
Wound infection  1  7/188 (3.72%)  7
Psychiatric disorders   
Hallucinations/post operative (op) psychosis  1  2/188 (1.06%)  2
Renal and urinary disorders   
Renal failure  1  2/188 (1.06%)  2
Urinary tract infection  1  1/188 (0.53%)  1
Reproductive system and breast disorders   
Pelvic abscess  1  1/188 (0.53%)  1
Respiratory, thoracic and mediastinal disorders   
Pulmonary embolism (PE)  1  3/188 (1.60%)  3
Pleural effusion  1  5/188 (2.66%)  5
Pneumothorax  1  1/188 (0.53%)  1
Stridor  1  1/188 (0.53%)  1
Voice changes  1  1/188 (0.53%)  1
Vascular disorders   
Deep venous thrombosis (DVT)  1  1/188 (0.53%)  1
Thrombosis jugular  1  1/188 (0.53%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTC2.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Mesothelioma, Low Grade, and Adenocarcinoma
Affected / at Risk (%) # Events
Total   2/188 (1.06%)    
Cardiac disorders   
Sinus ventricular tachycardia (SVT)  1  2/188 (1.06%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTC2.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Marybeth S. Hughes, M.D.
Organization: National Cancer Institute, National Institutes of Health
Phone: 301-594-9341
EMail: hughesm@mail.nih.gov
Layout table for additonal information
Responsible Party: Marybeth Hughes, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00004547     History of Changes
Obsolete Identifiers: NCT00020059
Other Study ID Numbers: 000069
00-C-0069
First Submitted: February 3, 2000
First Posted: February 4, 2000
Results First Submitted: August 30, 2011
Results First Posted: November 22, 2011
Last Update Posted: November 18, 2015