Trial Outcomes & Findings for Debulking and Chemotherapy With or Without Intraperitoneal Chemotherapy to Treat Peritoneal Carcinomatosis (NCT NCT00052962)

Last Updated: 2012-11-22

Results Overview

CHPP is administered as a heated cisplatin solution delivered to the abdomen through a catheter (plastic tube), washed through the abdomen for 90 minutes, and then drained out of the body through another catheter. Progression is defined as imageable tumor nodules or increasing ascites persistent on two serial computed tomography (CT) scans.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

30 participants

Primary outcome timeframe

2003-2008

Results posted on

2012-11-22

Participant Flow

Participant milestones

Participant milestones
Measure	Arm 1 Surgery + Post op Chemotherapy * Cytoreductive surgery * Post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-fluorouracil (5-FU), every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}.	Arm 2 Surgery + CHPP Arm 2 Surgery + Continuous hyperthermic peritoneal perfusion (CHPP) + post op dwell + post op chemotherapy * Cytoreductive surgery * continuous hyperthermic peritoneal perfusion (CHPP) with 250 mg/m\^2 cisplatin * post operative dwell chemotherapy given once between post op day 7 and 12: 5-fluorouracil (5FU) 800 mg/m\^2 and paclitaxel 125 mg/m\^2 * post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-FU, every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}.
Overall Study STARTED	13	17
Overall Study COMPLETED	12	15
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm 1 Surgery + Post op Chemotherapy * Cytoreductive surgery * Post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-fluorouracil (5-FU), every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}.	Arm 2 Surgery + CHPP Arm 2 Surgery + Continuous hyperthermic peritoneal perfusion (CHPP) + post op dwell + post op chemotherapy * Cytoreductive surgery * continuous hyperthermic peritoneal perfusion (CHPP) with 250 mg/m\^2 cisplatin * post operative dwell chemotherapy given once between post op day 7 and 12: 5-fluorouracil (5FU) 800 mg/m\^2 and paclitaxel 125 mg/m\^2 * post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-FU, every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}.
Overall Study Not evaluable	0	2
Overall Study Not randomized/not evaluable	1	0

Baseline Characteristics

Debulking and Chemotherapy With or Without Intraperitoneal Chemotherapy to Treat Peritoneal Carcinomatosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1 Surgery + Post op Chemotherapy n=13 Participants * Cytoreductive surgery * Post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-fluorouracil (5-FU), every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}.	Arm 2 Surgery + CHPP n=17 Participants Arm 2 Surgery + Continuous hyperthermic peritoneal perfusion (CHPP) + post op dwell + post op chemotherapy * Cytoreductive surgery * continuous hyperthermic peritoneal perfusion (CHPP) with 250 mg/m\^2 cisplatin * post operative dwell chemotherapy given once between post op day 7 and 12: 5-fluorouracil (5FU) 800 mg/m\^2 and paclitaxel 125 mg/m\^2 * post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-FU, every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}.	Total n=30 Participants Total of all reporting groups
Age Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Categorical Between 18 and 65 years	11 Participants n=5 Participants	15 Participants n=7 Participants	26 Participants n=5 Participants
Age Categorical >=65 years	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Age Continuous	51.08 years STANDARD_DEVIATION 15.58 • n=5 Participants	48.64 years STANDARD_DEVIATION 11.21 • n=7 Participants	50.55 years STANDARD_DEVIATION 13.14 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	10 Participants n=7 Participants	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants	16 Participants n=7 Participants	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized White	10 Participants n=5 Participants	13 Participants n=7 Participants	23 Participants n=5 Participants
Race/Ethnicity, Customized More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants	17 participants n=7 Participants	30 participants n=5 Participants

PRIMARY outcome

Timeframe: 2003-2008

Population: Study was closed July 2008 because the PI left the institution, thus the objective was not met.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2003-2008

Population: Three participants were not included in the analysis because one participant was not randomized/not evaluable, two were not evaluable, and/or information is not known.

Here is the number of participants with an adverse event. For a detailed list of adverse events see the adverse event module.

Outcome measures

Outcome measures
Measure	Arm 1 Surgery + Post op Chemotherapy n=13 Participants * Cytoreductive surgery * Post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-fluorouracil (5-FU), every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}.	Arm 2 Surgery + CHPP n=14 Participants Arm 2 Surgery + Continuous hyperthermic peritoneal perfusion (CHPP) + post op dwell + post op chemotherapy * Cytoreductive surgery * continuous hyperthermic peritoneal perfusion (CHPP) with 250 mg/m\^2 cisplatin * post operative dwell chemotherapy given once between post op day 7 and 12: 5-fluorouracil (5FU) 800 mg/m\^2 and paclitaxel 125 mg/m\^2 * post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-FU, every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}.
Number of Participants With an Adverse Event	7 Participants	6 Participants

Adverse Events

Arm 1 Surgery + Post op Chemotherapy

Serious events: 5 serious events

Other events: 2 other events

Deaths: 0 deaths

Arm 2 Surgery + CHPP

Serious events: 6 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm 1 Surgery + Post op Chemotherapy n=13 participants at risk * Cytoreductive surgery * Post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-fluorouracil (5-FU), every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}.	Arm 2 Surgery + CHPP n=14 participants at risk Arm 2 Surgery + Continuous hyperthermic peritoneal perfusion (CHPP) + post op dwell + post op chemotherapy * Cytoreductive surgery * continuous hyperthermic peritoneal perfusion (CHPP) with 250 mg/m\^2 cisplatin * post operative dwell chemotherapy given once between post op day 7 and 12: 5-fluorouracil (5FU) 800 mg/m\^2 and paclitaxel 125 mg/m\^2 * post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-FU, every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}.
Gastrointestinal disorders Ileus, wound infection	7.7% 1/13 • Number of events 1 Three participants were no included in the assessment because one participant was not randomized/not evaluable, two were not evaluable, and/or information is not known.	0.00% 0/14 Three participants were no included in the assessment because one participant was not randomized/not evaluable, two were not evaluable, and/or information is not known.
Metabolism and nutrition disorders Lipase gr	7.7% 1/13 • Number of events 1 Three participants were no included in the assessment because one participant was not randomized/not evaluable, two were not evaluable, and/or information is not known.	0.00% 0/14 Three participants were no included in the assessment because one participant was not randomized/not evaluable, two were not evaluable, and/or information is not known.
Gastrointestinal disorders Fistula intestinal	7.7% 1/13 • Number of events 1 Three participants were no included in the assessment because one participant was not randomized/not evaluable, two were not evaluable, and/or information is not known.	0.00% 0/14 Three participants were no included in the assessment because one participant was not randomized/not evaluable, two were not evaluable, and/or information is not known.
Gastrointestinal disorders Partial small bowel obstruction	0.00% 0/13 Three participants were no included in the assessment because one participant was not randomized/not evaluable, two were not evaluable, and/or information is not known.	7.1% 1/14 • Number of events 1 Three participants were no included in the assessment because one participant was not randomized/not evaluable, two were not evaluable, and/or information is not known.
Infections and infestations Sepsis	0.00% 0/13 Three participants were no included in the assessment because one participant was not randomized/not evaluable, two were not evaluable, and/or information is not known.	7.1% 1/14 • Number of events 1 Three participants were no included in the assessment because one participant was not randomized/not evaluable, two were not evaluable, and/or information is not known.
Infections and infestations Wound infection	0.00% 0/13 Three participants were no included in the assessment because one participant was not randomized/not evaluable, two were not evaluable, and/or information is not known.	7.1% 1/14 • Number of events 1 Three participants were no included in the assessment because one participant was not randomized/not evaluable, two were not evaluable, and/or information is not known.
Gastrointestinal disorders Post-op ileus	7.7% 1/13 • Number of events 1 Three participants were no included in the assessment because one participant was not randomized/not evaluable, two were not evaluable, and/or information is not known.	0.00% 0/14 Three participants were no included in the assessment because one participant was not randomized/not evaluable, two were not evaluable, and/or information is not known.
Infections and infestations Wound infection (superficial)	7.7% 1/13 • Number of events 1 Three participants were no included in the assessment because one participant was not randomized/not evaluable, two were not evaluable, and/or information is not known.	0.00% 0/14 Three participants were no included in the assessment because one participant was not randomized/not evaluable, two were not evaluable, and/or information is not known.
Hepatobiliary disorders AST	7.7% 1/13 • Number of events 1 Three participants were no included in the assessment because one participant was not randomized/not evaluable, two were not evaluable, and/or information is not known.	0.00% 0/14 Three participants were no included in the assessment because one participant was not randomized/not evaluable, two were not evaluable, and/or information is not known.
Gastrointestinal disorders Bowel perforation	0.00% 0/13 Three participants were no included in the assessment because one participant was not randomized/not evaluable, two were not evaluable, and/or information is not known.	7.1% 1/14 • Number of events 1 Three participants were no included in the assessment because one participant was not randomized/not evaluable, two were not evaluable, and/or information is not known.
Respiratory, thoracic and mediastinal disorders Pleural effusion/non-malignant	7.7% 1/13 • Number of events 1 Three participants were no included in the assessment because one participant was not randomized/not evaluable, two were not evaluable, and/or information is not known.	0.00% 0/14 Three participants were no included in the assessment because one participant was not randomized/not evaluable, two were not evaluable, and/or information is not known.
Reproductive system and breast disorders Abd pain	0.00% 0/13 Three participants were no included in the assessment because one participant was not randomized/not evaluable, two were not evaluable, and/or information is not known.	7.1% 1/14 • Number of events 1 Three participants were no included in the assessment because one participant was not randomized/not evaluable, two were not evaluable, and/or information is not known.
Respiratory, thoracic and mediastinal disorders Bilateral pleural effusion, bibasilar atelectasis, pelvic fluid	0.00% 0/13 Three participants were no included in the assessment because one participant was not randomized/not evaluable, two were not evaluable, and/or information is not known.	7.1% 1/14 • Number of events 1 Three participants were no included in the assessment because one participant was not randomized/not evaluable, two were not evaluable, and/or information is not known.
Hepatobiliary disorders ALT/AST	7.7% 1/13 • Number of events 1 Three participants were no included in the assessment because one participant was not randomized/not evaluable, two were not evaluable, and/or information is not known.	7.1% 1/14 • Number of events 1 Three participants were no included in the assessment because one participant was not randomized/not evaluable, two were not evaluable, and/or information is not known.

Other adverse events

Other adverse events
Measure	Arm 1 Surgery + Post op Chemotherapy n=13 participants at risk * Cytoreductive surgery * Post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-fluorouracil (5-FU), every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}.	Arm 2 Surgery + CHPP n=14 participants at risk Arm 2 Surgery + Continuous hyperthermic peritoneal perfusion (CHPP) + post op dwell + post op chemotherapy * Cytoreductive surgery * continuous hyperthermic peritoneal perfusion (CHPP) with 250 mg/m\^2 cisplatin * post operative dwell chemotherapy given once between post op day 7 and 12: 5-fluorouracil (5FU) 800 mg/m\^2 and paclitaxel 125 mg/m\^2 * post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-FU, every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}.
Renal and urinary disorders UTI	7.7% 1/13 • Number of events 1 Three participants were no included in the assessment because one participant was not randomized/not evaluable, two were not evaluable, and/or information is not known.	0.00% 0/14 Three participants were no included in the assessment because one participant was not randomized/not evaluable, two were not evaluable, and/or information is not known.
Cardiac disorders SVT	7.7% 1/13 • Number of events 1 Three participants were no included in the assessment because one participant was not randomized/not evaluable, two were not evaluable, and/or information is not known.	0.00% 0/14 Three participants were no included in the assessment because one participant was not randomized/not evaluable, two were not evaluable, and/or information is not known.
Renal and urinary disorders UTI: pyelonephritis	7.7% 1/13 • Number of events 1 Three participants were no included in the assessment because one participant was not randomized/not evaluable, two were not evaluable, and/or information is not known.	0.00% 0/14 Three participants were no included in the assessment because one participant was not randomized/not evaluable, two were not evaluable, and/or information is not known.
Respiratory, thoracic and mediastinal disorders Pleural effusion post op	7.7% 1/13 • Number of events 1 Three participants were no included in the assessment because one participant was not randomized/not evaluable, two were not evaluable, and/or information is not known.	0.00% 0/14 Three participants were no included in the assessment because one participant was not randomized/not evaluable, two were not evaluable, and/or information is not known.

Additional Information

Marybeth 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