Trial Outcomes & Findings for Octreotide in Treating Patients With Cancer-Related Malignant Ascites (NCT NCT00182754)
NCT ID: NCT00182754
Last Updated: 2017-04-11
Results Overview
Kaplan Meier curves will be constructed for each group; patients lost to follow up will be censored. A log rank test will be used to compare groups. We will adjust for the volume of fluid withdrawn at paracentesis and for change in abdominal circumference between baseline and the next procedure because a patient may require an extra paracentesis if only a small volume is withdrawn at baseline.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
33 participants
Primary outcome timeframe
Up to 2 years
Results posted on
2017-04-11
Participant Flow
Participant milestones
| Measure |
Arm I
Patients receive 30 mg octreotide subcutaneously (SC) intramuscularly once on day 1. octreotide acetate: Given subcutaneously
|
Arm II
Patients receive 2 milliliters placebo (0.9% sodium chloride) SC once on day 1. placebo: Given subcutaneously
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
17
|
|
Overall Study
COMPLETED
|
16
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Octreotide in Treating Patients With Cancer-Related Malignant Ascites
Baseline characteristics by cohort
| Measure |
Arm I
n=16 Participants
Patients receive 30 mg octreotide subcutaneously (SC) intramuscularly once on day 1. octreotide acetate: Given subcutaneously
|
Arm II
n=17 Participants
Patients receive 2 milliliters placebo (0.9% sodium chloride) SC once on day 1. placebo: Given subcutaneously
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62 years
n=5 Participants
|
69 years
n=7 Participants
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsKaplan Meier curves will be constructed for each group; patients lost to follow up will be censored. A log rank test will be used to compare groups. We will adjust for the volume of fluid withdrawn at paracentesis and for change in abdominal circumference between baseline and the next procedure because a patient may require an extra paracentesis if only a small volume is withdrawn at baseline.
Outcome measures
| Measure |
Arm I
n=16 Participants
Patients receive 30 mg octreotide subcutaneously (SC) intramuscularly once on day 1. octreotide acetate: Given subcutaneously
|
Arm II
n=17 Participants
Patients receive 2 milliliters placebo (0.9% sodium chloride) SC once on day 1. placebo: Given subcutaneously
|
|---|---|---|
|
Median Time to Paracentesis
|
28 days
Interval 4.0 to 45.0
|
14 days
Interval 4.0 to 28.0
|
SECONDARY outcome
Timeframe: Up to 2 yearsWe will compare the number of paracenteses between groups. Parametric or nonparametric testing will be used as appropriate.
Outcome measures
| Measure |
Arm I
n=16 Participants
Patients receive 30 mg octreotide subcutaneously (SC) intramuscularly once on day 1. octreotide acetate: Given subcutaneously
|
Arm II
n=17 Participants
Patients receive 2 milliliters placebo (0.9% sodium chloride) SC once on day 1. placebo: Given subcutaneously
|
|---|---|---|
|
Number of Paracenteses
|
0.5 number of paracenteses per patient
Interval 0.0 to 4.0
|
1 number of paracenteses per patient
Interval 0.0 to 4.0
|
SECONDARY outcome
Timeframe: Up to 2 yearsQuality of life will be recorded and analyzed in a descriptive, exploratory fashion. We acknowledge that this study will represent the first to attempt a prospective assessment of quality of life in patients with symptomatic ascites. The underlying hypothesis of this quality of life assessment is that patients who are receiving octreotide will enjoy a better quality of life compared to patients who receive placebo. Quality of life scores from the CLDQ will be summed for all patients on a monthly basis. Again we anticipate high patient drop out rates over time within these two cohorts. With due diligence, we will attempt to ascertain the reason for each patient drop out, and appropriate imputation techniques will be employed for each.Quantified as: 1='All of the time' 2='Most of the time' 3='A good bit of the time' 4='Some of the time' 5='A little bit of the time' 6='Hardly any of the time' 7='None of the time' 0='Missing';
Outcome measures
| Measure |
Arm I
n=10 Participants
Patients receive 30 mg octreotide subcutaneously (SC) intramuscularly once on day 1. octreotide acetate: Given subcutaneously
|
Arm II
n=15 Participants
Patients receive 2 milliliters placebo (0.9% sodium chloride) SC once on day 1. placebo: Given subcutaneously
|
|---|---|---|
|
Average Quality-of-life
abdominal bloating
|
4 QOL score
Interval 1.0 to 6.0
|
3 QOL score
Interval 1.0 to 6.0
|
|
Average Quality-of-life
shortness of breath
|
4 QOL score
Interval 3.0 to 7.0
|
3 QOL score
Interval 1.0 to 6.0
|
|
Average Quality-of-life
abdominal discomfort
|
4.5 QOL score
Interval 2.0 to 5.0
|
2 QOL score
Interval 1.0 to 6.0
|
Adverse Events
Arm I
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Arm II
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I
n=16 participants at risk
Patients receive 30 mg octreotide subcutaneously (SC) intramuscularly once on day 1. octreotide acetate: Given subcutaneously
|
Arm II
n=17 participants at risk
Patients receive 2 milliliters placebo (0.9% sodium chloride) SC once on day 1. placebo: Given subcutaneously
|
|---|---|---|
|
Metabolism and nutrition disorders
Dehydration
|
6.2%
1/16 • Number of events 1
|
0.00%
0/17
|
Other adverse events
| Measure |
Arm I
n=16 participants at risk
Patients receive 30 mg octreotide subcutaneously (SC) intramuscularly once on day 1. octreotide acetate: Given subcutaneously
|
Arm II
n=17 participants at risk
Patients receive 2 milliliters placebo (0.9% sodium chloride) SC once on day 1. placebo: Given subcutaneously
|
|---|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
6.2%
1/16 • Number of events 5
|
0.00%
0/17
|
|
Blood and lymphatic system disorders
Lymphatic disorder
|
6.2%
1/16 • Number of events 1
|
0.00%
0/17
|
|
Cardiac disorders
Atrial fibrillation
|
6.2%
1/16 • Number of events 1
|
0.00%
0/17
|
|
Gastrointestinal disorders
Abdominal distension
|
6.2%
1/16 • Number of events 1
|
5.9%
1/17 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
62.5%
10/16 • Number of events 20
|
70.6%
12/17 • Number of events 14
|
|
Gastrointestinal disorders
Anal fistula
|
6.2%
1/16 • Number of events 1
|
0.00%
0/17
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/16
|
5.9%
1/17 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
37.5%
6/16 • Number of events 10
|
41.2%
7/17 • Number of events 9
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
4/16 • Number of events 14
|
29.4%
5/17 • Number of events 6
|
|
Gastrointestinal disorders
Nausea
|
25.0%
4/16 • Number of events 4
|
5.9%
1/17 • Number of events 1
|
|
Gastrointestinal disorders
Proctitis
|
12.5%
2/16 • Number of events 2
|
5.9%
1/17 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
18.8%
3/16 • Number of events 3
|
11.8%
2/17 • Number of events 2
|
|
General disorders
Chest pain
|
0.00%
0/16
|
5.9%
1/17 • Number of events 1
|
|
General disorders
Death NOS
|
0.00%
0/16
|
5.9%
1/17 • Number of events 1
|
|
General disorders
Disease progression
|
31.2%
5/16 • Number of events 5
|
17.6%
3/17 • Number of events 3
|
|
General disorders
Fatigue
|
18.8%
3/16 • Number of events 4
|
11.8%
2/17 • Number of events 2
|
|
General disorders
Injection site reaction
|
6.2%
1/16 • Number of events 2
|
0.00%
0/17
|
|
General disorders
Localized edema
|
0.00%
0/16
|
5.9%
1/17 • Number of events 1
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/16
|
5.9%
1/17 • Number of events 1
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/16
|
5.9%
1/17 • Number of events 1
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
6.2%
1/16 • Number of events 1
|
0.00%
0/17
|
|
Investigations
Activated partial thromboplastin time prolonged
|
6.2%
1/16 • Number of events 2
|
0.00%
0/17
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/16
|
5.9%
1/17 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
6.2%
1/16 • Number of events 1
|
0.00%
0/17
|
|
Investigations
Blood bilirubin increased
|
12.5%
2/16 • Number of events 2
|
5.9%
1/17 • Number of events 1
|
|
Investigations
Creatinine increased
|
6.2%
1/16 • Number of events 1
|
0.00%
0/17
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/16
|
5.9%
1/17 • Number of events 1
|
|
Investigations
Leukocyte count decreased
|
6.2%
1/16 • Number of events 1
|
0.00%
0/17
|
|
Investigations
Neutrophil count decreased
|
12.5%
2/16 • Number of events 4
|
0.00%
0/17
|
|
Investigations
Platelet count decreased
|
6.2%
1/16 • Number of events 4
|
0.00%
0/17
|
|
Investigations
Weight gain
|
6.2%
1/16 • Number of events 1
|
0.00%
0/17
|
|
Metabolism and nutrition disorders
Anorexia
|
12.5%
2/16 • Number of events 2
|
5.9%
1/17 • Number of events 1
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
12.5%
2/16 • Number of events 2
|
0.00%
0/17
|
|
Metabolism and nutrition disorders
Dehydration
|
12.5%
2/16 • Number of events 2
|
5.9%
1/17 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
0.00%
0/16
|
11.8%
2/17 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
6.2%
1/16 • Number of events 1
|
0.00%
0/17
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
6.2%
1/16 • Number of events 1
|
0.00%
0/17
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
6.2%
1/16 • Number of events 1
|
5.9%
1/17 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/16
|
5.9%
1/17 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
0.00%
0/16
|
5.9%
1/17 • Number of events 1
|
|
Nervous system disorders
Cognitive disturbance
|
6.2%
1/16 • Number of events 1
|
0.00%
0/17
|
|
Nervous system disorders
Dizziness
|
6.2%
1/16 • Number of events 1
|
0.00%
0/17
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/16
|
5.9%
1/17 • Number of events 1
|
|
Nervous system disorders
Peripheral motor neuropathy
|
6.2%
1/16 • Number of events 1
|
0.00%
0/17
|
|
Psychiatric disorders
Confusion
|
0.00%
0/16
|
5.9%
1/17 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
6.2%
1/16 • Number of events 1
|
0.00%
0/17
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.2%
1/16 • Number of events 1
|
0.00%
0/17
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.2%
1/16 • Number of events 1
|
0.00%
0/17
|
|
Vascular disorders
Hypotension
|
6.2%
1/16 • Number of events 1
|
0.00%
0/17
|
|
Vascular disorders
Vascular disorder
|
0.00%
0/16
|
5.9%
1/17 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place