Trial Outcomes & Findings for Treatment of Peritoneal Cancer With Surgery, Perfused Heated Cisplatin and Chemotherapy (NCT NCT00004547)
NCT ID: NCT00004547
Last Updated: 2015-11-18
Results Overview
Participants who achieve either a six or twelve month disease free interval based on radiographic imaging and symptoms.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
188 participants
Primary outcome timeframe
On study date until the first scan with imageable disease, assessed up to 100 months or more.
Results posted on
2015-11-18
Participant Flow
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).
Participant milestones
| Measure |
Peritoneal Mesothelioma
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
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
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 Study
STARTED
|
83
|
48
|
57
|
|
Overall Study
Not Evaluable
|
21
|
9
|
23
|
|
Overall Study
COMPLETED
|
61
|
39
|
35
|
|
Overall Study
NOT COMPLETED
|
22
|
9
|
22
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment of Peritoneal Cancer With Surgery, Perfused Heated Cisplatin and Chemotherapy
Baseline characteristics by cohort
| Measure |
Peritoneal Mesothelioma
n=83 Participants
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
n=48 Participants
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
n=57 Participants
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
n=188 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
71 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
166 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Age, Continuous
|
49.95 years
STANDARD_DEVIATION 14.12 • n=5 Participants
|
50.48 years
STANDARD_DEVIATION 10.85 • n=7 Participants
|
49.70 years
STANDARD_DEVIATION 11.78 • n=5 Participants
|
50.01 years
STANDARD_DEVIATION 12.61 • n=4 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
89 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
99 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
69 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
161 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
6 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
African American
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian American
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
83 participants
n=5 Participants
|
48 participants
n=7 Participants
|
57 participants
n=5 Participants
|
188 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: On study date until the first scan with imageable disease, assessed up to 100 months or more.Population: This outcome measure was not analyzed because information was not consistently available.
Participants who achieve either a six or twelve month disease free interval based on radiographic imaging and symptoms.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Patients were assessed every three months for one year and then every 6 monthsResponse 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.
Outcome measures
| Measure |
Peritoneal Mesothelioma
n=83 Participants
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
n=48 Participants
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
n=57 Participants
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.
|
|---|---|---|---|
|
Number of Participants With a Response
|
24 Participants
|
18 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: only assessed during the perioperative period (i.e. up to 90 days following surgery)Population: 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).
Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.
Outcome measures
| Measure |
Peritoneal Mesothelioma
n=188 Participants
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
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
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.
|
|---|---|---|---|
|
Number of Participants With Adverse Events
|
73 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Perioperative day 7-12 after surgeryPopulation: This outcome measure was not analyzed because it was not feasible (e.g. inadequate samples).
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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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 studyPopulation: This outcome measure was not evaluated due to poor patient compliance.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: once during surgeryPopulation: This outcome measure was not analyzed because it was not feasible.
Signal transduction pathways were measured using reverse phase protein lysate microarray to determine if the pathways are distinct in tumor versus normal tissue.
Outcome measures
Outcome data not reported
Adverse Events
Mesothelioma, Low Grade, and Adenocarcinoma
Serious events: 71 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Mesothelioma, Low Grade, and Adenocarcinoma
n=188 participants at risk
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.
|
|---|---|
|
Gastrointestinal disorders
ascites
|
1.1%
2/188 • Number of events 2
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).
|
|
Cardiac disorders
atrial fibrillation
|
0.53%
1/188 • Number of events 1
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).
|
|
Hepatobiliary disorders
cholecystitis
|
0.53%
1/188 • Number of events 1
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).
|
|
Gastrointestinal disorders
colitis
|
0.53%
1/188 • Number of events 1
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).
|
|
Gastrointestinal disorders
colon perforation
|
1.1%
2/188 • Number of events 2
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).
|
|
Gastrointestinal disorders
diarrhea
|
0.53%
1/188 • Number of events 1
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).
|
|
Vascular disorders
Deep venous thrombosis (DVT)
|
0.53%
1/188 • Number of events 1
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).
|
|
Gastrointestinal disorders
Enterocutaneous fistula
|
1.1%
2/188 • Number of events 2
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).
|
|
Gastrointestinal disorders
Gastric perforation
|
0.53%
1/188 • Number of events 1
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).
|
|
Gastrointestinal disorders
Gastrointestinal (GI) perforation
|
0.53%
1/188 • Number of events 1
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).
|
|
Psychiatric disorders
Hallucinations/post operative (op) psychosis
|
1.1%
2/188 • Number of events 2
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).
|
|
Gastrointestinal disorders
Ileus
|
1.1%
2/188 • Number of events 2
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).
|
|
Cardiac disorders
Myocardial infarction
|
0.53%
1/188 • Number of events 1
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).
|
|
Gastrointestinal disorders
Nausea
|
2.1%
4/188 • Number of events 4
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).
|
|
Infections and infestations
Neutropenic fever
|
2.7%
5/188 • Number of events 5
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).
|
|
Gastrointestinal disorders
Pancreatic fistula
|
0.53%
1/188 • Number of events 1
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).
|
|
Gastrointestinal disorders
Pancreatitis
|
1.6%
3/188 • Number of events 3
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).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism (PE)
|
1.6%
3/188 • Number of events 3
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).
|
|
Reproductive system and breast disorders
Pelvic abscess
|
0.53%
1/188 • Number of events 1
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).
|
|
Gastrointestinal disorders
Perforated bowel
|
0.53%
1/188 • Number of events 1
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).
|
|
Gastrointestinal disorders
Peritonitis
|
0.53%
1/188 • Number of events 1
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).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.7%
5/188 • Number of events 5
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).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.53%
1/188 • Number of events 1
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).
|
|
Renal and urinary disorders
Renal failure
|
1.1%
2/188 • Number of events 2
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).
|
|
Gastrointestinal disorders
Small bowel obstruction (sbo)
|
0.53%
1/188 • Number of events 1
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).
|
|
Infections and infestations
Sepsis
|
0.53%
1/188 • Number of events 1
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).
|
|
Gastrointestinal disorders
Small bowel obstruction
|
6.4%
12/188 • Number of events 12
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).
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.53%
1/188 • Number of events 1
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).
|
|
Vascular disorders
Thrombosis jugular
|
0.53%
1/188 • Number of events 1
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).
|
|
Hepatobiliary disorders
Thrombosis portal vein
|
0.53%
1/188 • Number of events 1
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).
|
|
Renal and urinary disorders
Urinary tract infection
|
0.53%
1/188 • Number of events 1
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).
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes
|
0.53%
1/188 • Number of events 1
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).
|
|
Infections and infestations
Wound infection
|
3.7%
7/188 • Number of events 7
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).
|
Other adverse events
| Measure |
Mesothelioma, Low Grade, and Adenocarcinoma
n=188 participants at risk
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.
|
|---|---|
|
Cardiac disorders
Sinus ventricular tachycardia (SVT)
|
1.1%
2/188 • Number of events 2
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).
|
Additional Information
Marybeth S. Hughes, M.D.
National Cancer Institute, National Institutes of Health
Phone: 301-594-9341
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place