Trial Outcomes & Findings for A Phase II Study of Surgical Debulking With Peritonectomy and Biweekly Intraperitoneal 5FU With Systemic Oxaliplatin/5FU/Leucovorin in Patients With Pseudomyxoma Peritonei or Peritoneal Carcinomatosis (NCT NCT00352755)
NCT ID: NCT00352755
Last Updated: 2016-12-13
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
30 days after end of treatment
Results posted on
2016-12-13
Participant Flow
Participant milestones
| Measure |
Peritonectomy + IP5FU + FOLFOX
* Surgical debulking with peritonectomy
* IP 5FU 600 mg/m\^2 over 30-60 minutes with patient rotating every 15 minutes. Repeated every 2 weeks for a total of 9 cycles.
* FOLFOX (oxaliplatin, 5FU, leucovorin) will follow IP therapy. Oxaliplatin 85 mg/m\^2 over 2 hours with leucovorin at 400 mg/m\^2 and IV 5-FU at 2400 mg/m\^2 over 46 hours. Repeated every 2 weeks for a total of 8 cycles.
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Peritonectomy + IP5FU + FOLFOX
* Surgical debulking with peritonectomy
* IP 5FU 600 mg/m\^2 over 30-60 minutes with patient rotating every 15 minutes. Repeated every 2 weeks for a total of 9 cycles.
* FOLFOX (oxaliplatin, 5FU, leucovorin) will follow IP therapy. Oxaliplatin 85 mg/m\^2 over 2 hours with leucovorin at 400 mg/m\^2 and IV 5-FU at 2400 mg/m\^2 over 46 hours. Repeated every 2 weeks for a total of 8 cycles.
|
|---|---|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
A Phase II Study of Surgical Debulking With Peritonectomy and Biweekly Intraperitoneal 5FU With Systemic Oxaliplatin/5FU/Leucovorin in Patients With Pseudomyxoma Peritonei or Peritoneal Carcinomatosis
Baseline characteristics by cohort
| Measure |
Peritonectomy + IP5FU + FOLFOX
n=18 Participants
* Surgical debulking with peritonectomy
* IP 5FU 600 mg/m\^2 over 30-60 minutes with patient rotating every 15 minutes. Repeated every 2 weeks for a total of 9 cycles.
* FOLFOX (oxaliplatin, 5FU, leucovorin) will follow IP therapy. Oxaliplatin 85 mg/m\^2 over 2 hours with leucovorin at 400 mg/m\^2 and IV 5-FU at 2400 mg/m\^2 over 46 hours. Repeated every 2 weeks for a total of 8 cycles.
|
|---|---|
|
Age, Continuous
|
58 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 days after end of treatmentOutcome measures
| Measure |
Peritonectomy + IP5FU + FOLFOX
n=18 Participants
* Surgical debulking with peritonectomy
* IP 5FU 600 mg/m\^2 over 30-60 minutes with patient rotating every 15 minutes. Repeated every 2 weeks for a total of 9 cycles.
* FOLFOX (oxaliplatin, 5FU, leucovorin) will follow IP therapy. Oxaliplatin 85 mg/m\^2 over 2 hours with leucovorin at 400 mg/m\^2 and IV 5-FU at 2400 mg/m\^2 over 46 hours. Repeated every 2 weeks for a total of 8 cycles.
|
|---|---|
|
Safety and Tolerability of the Planned Treatment Regimen as Measured by Number of Participants With Grade 3 or Higher Adverse Events
Hyponatremia
|
2 participants
|
|
Safety and Tolerability of the Planned Treatment Regimen as Measured by Number of Participants With Grade 3 or Higher Adverse Events
Syncope
|
1 participants
|
|
Safety and Tolerability of the Planned Treatment Regimen as Measured by Number of Participants With Grade 3 or Higher Adverse Events
Hemoglobin
|
1 participants
|
|
Safety and Tolerability of the Planned Treatment Regimen as Measured by Number of Participants With Grade 3 or Higher Adverse Events
Leukocytes
|
1 participants
|
|
Safety and Tolerability of the Planned Treatment Regimen as Measured by Number of Participants With Grade 3 or Higher Adverse Events
Lymphopenia
|
3 participants
|
|
Safety and Tolerability of the Planned Treatment Regimen as Measured by Number of Participants With Grade 3 or Higher Adverse Events
Neutrophils
|
2 participants
|
|
Safety and Tolerability of the Planned Treatment Regimen as Measured by Number of Participants With Grade 3 or Higher Adverse Events
Rigors/chills
|
1 participants
|
|
Safety and Tolerability of the Planned Treatment Regimen as Measured by Number of Participants With Grade 3 or Higher Adverse Events
Dehydration
|
2 participants
|
|
Safety and Tolerability of the Planned Treatment Regimen as Measured by Number of Participants With Grade 3 or Higher Adverse Events
Nausea
|
3 participants
|
|
Safety and Tolerability of the Planned Treatment Regimen as Measured by Number of Participants With Grade 3 or Higher Adverse Events
Vomiting
|
2 participants
|
|
Safety and Tolerability of the Planned Treatment Regimen as Measured by Number of Participants With Grade 3 or Higher Adverse Events
Febrile neutropenia
|
1 participants
|
|
Safety and Tolerability of the Planned Treatment Regimen as Measured by Number of Participants With Grade 3 or Higher Adverse Events
Anal/perianal infection
|
1 participants
|
|
Safety and Tolerability of the Planned Treatment Regimen as Measured by Number of Participants With Grade 3 or Higher Adverse Events
Urinary infection
|
1 participants
|
|
Safety and Tolerability of the Planned Treatment Regimen as Measured by Number of Participants With Grade 3 or Higher Adverse Events
Infection (clinic or micro) with Gr. 3/4 ANC
|
1 participants
|
|
Safety and Tolerability of the Planned Treatment Regimen as Measured by Number of Participants With Grade 3 or Higher Adverse Events
Wound infection
|
2 participants
|
|
Safety and Tolerability of the Planned Treatment Regimen as Measured by Number of Participants With Grade 3 or Higher Adverse Events
Alanine aminotransferase (ALT)
|
1 participants
|
|
Safety and Tolerability of the Planned Treatment Regimen as Measured by Number of Participants With Grade 3 or Higher Adverse Events
Creatinine
|
1 participants
|
|
Safety and Tolerability of the Planned Treatment Regimen as Measured by Number of Participants With Grade 3 or Higher Adverse Events
Hypermagnesemia
|
1 participants
|
|
Safety and Tolerability of the Planned Treatment Regimen as Measured by Number of Participants With Grade 3 or Higher Adverse Events
Hypocalcemia
|
1 participants
|
|
Safety and Tolerability of the Planned Treatment Regimen as Measured by Number of Participants With Grade 3 or Higher Adverse Events
Hypokalemia
|
2 participants
|
|
Safety and Tolerability of the Planned Treatment Regimen as Measured by Number of Participants With Grade 3 or Higher Adverse Events
Hypomagnesemia
|
1 participants
|
|
Safety and Tolerability of the Planned Treatment Regimen as Measured by Number of Participants With Grade 3 or Higher Adverse Events
Abdomen pain
|
3 participants
|
|
Safety and Tolerability of the Planned Treatment Regimen as Measured by Number of Participants With Grade 3 or Higher Adverse Events
Head/headache pain
|
1 participants
|
SECONDARY outcome
Timeframe: Median follow-up was 32 months-Progressive disease - at least a 20% increase in the sum of the longest diameter of the target lesions taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.
Outcome measures
| Measure |
Peritonectomy + IP5FU + FOLFOX
n=16 Participants
* Surgical debulking with peritonectomy
* IP 5FU 600 mg/m\^2 over 30-60 minutes with patient rotating every 15 minutes. Repeated every 2 weeks for a total of 9 cycles.
* FOLFOX (oxaliplatin, 5FU, leucovorin) will follow IP therapy. Oxaliplatin 85 mg/m\^2 over 2 hours with leucovorin at 400 mg/m\^2 and IV 5-FU at 2400 mg/m\^2 over 46 hours. Repeated every 2 weeks for a total of 8 cycles.
|
|---|---|
|
Progression Rate
|
62.5 percentage of participants
|
SECONDARY outcome
Timeframe: Median follow-up was 32 monthsOutcome measures
| Measure |
Peritonectomy + IP5FU + FOLFOX
n=16 Participants
* Surgical debulking with peritonectomy
* IP 5FU 600 mg/m\^2 over 30-60 minutes with patient rotating every 15 minutes. Repeated every 2 weeks for a total of 9 cycles.
* FOLFOX (oxaliplatin, 5FU, leucovorin) will follow IP therapy. Oxaliplatin 85 mg/m\^2 over 2 hours with leucovorin at 400 mg/m\^2 and IV 5-FU at 2400 mg/m\^2 over 46 hours. Repeated every 2 weeks for a total of 8 cycles.
|
|---|---|
|
Number of Participants Who Experience Surgical Complications Associated With This Regimen
|
9 participants
|
SECONDARY outcome
Timeframe: Median follow-up was 32 monthsOutcome measures
| Measure |
Peritonectomy + IP5FU + FOLFOX
n=16 Participants
* Surgical debulking with peritonectomy
* IP 5FU 600 mg/m\^2 over 30-60 minutes with patient rotating every 15 minutes. Repeated every 2 weeks for a total of 9 cycles.
* FOLFOX (oxaliplatin, 5FU, leucovorin) will follow IP therapy. Oxaliplatin 85 mg/m\^2 over 2 hours with leucovorin at 400 mg/m\^2 and IV 5-FU at 2400 mg/m\^2 over 46 hours. Repeated every 2 weeks for a total of 8 cycles.
|
|---|---|
|
Progression-free Survival
|
21.20 months
Interval 1.41 to 34.36
|
SECONDARY outcome
Timeframe: Median follow-up was 32 monthsOutcome measures
| Measure |
Peritonectomy + IP5FU + FOLFOX
n=16 Participants
* Surgical debulking with peritonectomy
* IP 5FU 600 mg/m\^2 over 30-60 minutes with patient rotating every 15 minutes. Repeated every 2 weeks for a total of 9 cycles.
* FOLFOX (oxaliplatin, 5FU, leucovorin) will follow IP therapy. Oxaliplatin 85 mg/m\^2 over 2 hours with leucovorin at 400 mg/m\^2 and IV 5-FU at 2400 mg/m\^2 over 46 hours. Repeated every 2 weeks for a total of 8 cycles.
|
|---|---|
|
Overall Survival
|
32.01 months
Interval 4.27 to 35.61
|
Adverse Events
Peritonectomy + IP5FU + FOLFOX
Serious events: 3 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Peritonectomy + IP5FU + FOLFOX
n=18 participants at risk
* Surgical debulking with peritonectomy
* IP 5FU 600 mg/m2 over 30-60 minutes with patient rotating every 15 minutes. Repeated every 2 weeks for a total of 9 cycles.
* FOLFOX (oxaliplatin, 5FU, leucovorin) will follow IP therapy. Oxaliplatin 85 mg/m2 over 2 hours with leucovorin at 400 mg/m2 and IV 5-FU at 2400 mg/m2 over 46 hours. Repeated every 2 weeks for a total of 8 cycles.
|
|---|---|
|
Metabolism and nutrition disorders
Dehydration
|
5.6%
1/18
|
|
General disorders
Fatigue
|
5.6%
1/18
|
|
General disorders
Fever
|
11.1%
2/18
|
|
Infections and infestations
Infection - wound
|
5.6%
1/18
|
|
Gastrointestinal disorders
Nausea
|
5.6%
1/18
|
|
General disorders
Rigors/chills
|
11.1%
2/18
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
1/18
|
Other adverse events
| Measure |
Peritonectomy + IP5FU + FOLFOX
n=18 participants at risk
* Surgical debulking with peritonectomy
* IP 5FU 600 mg/m2 over 30-60 minutes with patient rotating every 15 minutes. Repeated every 2 weeks for a total of 9 cycles.
* FOLFOX (oxaliplatin, 5FU, leucovorin) will follow IP therapy. Oxaliplatin 85 mg/m2 over 2 hours with leucovorin at 400 mg/m2 and IV 5-FU at 2400 mg/m2 over 46 hours. Repeated every 2 weeks for a total of 8 cycles.
|
|---|---|
|
Investigations
ALT
|
38.9%
7/18
|
|
Investigations
AST
|
38.9%
7/18
|
|
Gastrointestinal disorders
Abdominal pain
|
44.4%
8/18
|
|
Investigations
Alkaline phosphatase
|
27.8%
5/18
|
|
Metabolism and nutrition disorders
Anorexia
|
16.7%
3/18
|
|
Cardiac disorders
Atrial fibrillation
|
5.6%
1/18
|
|
Investigations
Bilirubin
|
5.6%
1/18
|
|
Eye disorders
Blurred vision
|
5.6%
1/18
|
|
Cardiac disorders
Chest/thorax pain
|
11.1%
2/18
|
|
Gastrointestinal disorders
Constipation
|
11.1%
2/18
|
|
Investigations
Creatinine
|
11.1%
2/18
|
|
Metabolism and nutrition disorders
Dehydration
|
11.1%
2/18
|
|
Psychiatric disorders
Depression
|
11.1%
2/18
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
6/18
|
|
General disorders
Fatigue
|
38.9%
7/18
|
|
Infections and infestations
Febrile neutropenia
|
5.6%
1/18
|
|
Gastrointestinal disorders
Gastrointestinal, other
|
11.1%
2/18
|
|
Nervous system disorders
Head/headache
|
5.6%
1/18
|
|
Investigations
Hematocrit
|
11.1%
2/18
|
|
Blood and lymphatic system disorders
Hemoglobin
|
55.6%
10/18
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs
|
5.6%
1/18
|
|
Vascular disorders
Hot flashes
|
5.6%
1/18
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
11.1%
2/18
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.6%
1/18
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
5.6%
1/18
|
|
Metabolism and nutrition disorders
Hypernatremia
|
5.6%
1/18
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
5.6%
1/18
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
11.1%
2/18
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
11.1%
2/18
|
|
Metabolism and nutrition disorders
Hypokalemia
|
11.1%
2/18
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
11.1%
2/18
|
|
Metabolism and nutrition disorders
Hyponatremia
|
11.1%
2/18
|
|
Gastrointestinal disorders
Ileus
|
5.6%
1/18
|
|
Infections and infestations
Infection - Anal/Perianal
|
5.6%
1/18
|
|
Infections and infestations
Infection - Kidney
|
11.1%
2/18
|
|
Infections and infestations
Infection - Oral - Cavity, gums
|
5.6%
1/18
|
|
Infections and infestations
Infection - Urinary
|
5.6%
1/18
|
|
Infections and infestations
Infection with Gr.3/4 neutrophils
|
5.6%
1/18
|
|
General disorders
Injection site reaction
|
5.6%
1/18
|
|
Psychiatric disorders
Insomnia
|
11.1%
2/18
|
|
Investigations
Leukocytes
|
27.8%
5/18
|
|
Investigations
Lymphopenia
|
33.3%
6/18
|
|
Metabolism and nutrition disorders
Metabolic - Other
|
5.6%
1/18
|
|
Gastrointestinal disorders
Mucositis
|
5.6%
1/18
|
|
Musculoskeletal and connective tissue disorders
Muscle pain
|
11.1%
2/18
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal - Other
|
11.1%
2/18
|
|
Gastrointestinal disorders
Nausea
|
38.9%
7/18
|
|
Nervous system disorders
Neuropathy - sensory
|
38.9%
7/18
|
|
Investigations
Neutrophils
|
22.2%
4/18
|
|
Respiratory, thoracic and mediastinal disorders
Nose bleed
|
5.6%
1/18
|
|
Gastrointestinal disorders
Oral cavity
|
5.6%
1/18
|
|
General disorders
Pain
|
16.7%
3/18
|
|
Vascular disorders
Phlebitis
|
5.6%
1/18
|
|
Investigations
Platelets
|
33.3%
6/18
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
5.6%
1/18
|
|
General disorders
Rigors/chills
|
11.1%
2/18
|
|
Reproductive system and breast disorders
Sexual - other
|
11.1%
2/18
|
|
Skin and subcutaneous tissue disorders
Skin breakdown/decubitus ulcer
|
5.6%
1/18
|
|
Nervous system disorders
Syncope (fainting)
|
5.6%
1/18
|
|
Investigations
Thrombocytopenia
|
5.6%
1/18
|
|
Reproductive system and breast disorders
Vaginal perforation
|
5.6%
1/18
|
|
Gastrointestinal disorders
Vomiting
|
38.9%
7/18
|
|
Injury, poisoning and procedural complications
Wound complication, non-infectious
|
5.6%
1/18
|
|
Infections and infestations
Wound infection
|
16.7%
3/18
|
Additional Information
Dr. James Fleshman
Washington University School of Medicine
Phone: 314-747-4610
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place