Octreotide in Treating Patients With Cancer-Related Malignant Ascites

• Sponsor: Alliance for Clinical Trials in Oncology (Other)
• Overall Status: Completed
• CT.gov ID: NCT00182754
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 33
• Locations: 122
• Arms: 2
• Duration (Months): 89
• Patients Per Site: 0.3
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

RATIONALE: Octreotide may be an effective treatment for malignant ascites. It is not yet known whether octreotide is more effective than a placebo in treating malignant ascites.

PURPOSE: This randomized phase III trial is studying octreotide to see how well it works compared to placebo in treating patients with cancer-related malignant ascites.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Cancer; Unspecified Adult Solid Tumor, Protocol Specific	Drug: octreotide acetate; Other: placebo	Phase 3

Detailed Description

OBJECTIVES:

Primary

• Compare the efficacy of octreotide vs placebo, in terms of extending the time-to-paracentesis, in patients with cancer-related symptomatic malignant ascites.

Secondary

• Compare the number of paracenteses in patients treated with these drugs.

• Determine the toxicity of octreotide in these patients.

• Compare the quality of life of patients treated with these drugs.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to anticipated ongoing chemotherapy (yes vs no), frequency of prior paracentesis (never vs other), and prior chemotherapy (never vs only first-line chemotherapy vs second-line chemotherapy vs other). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive octreotide subcutaneously (SC) once on day 1.

• Arm II: Patients receive placebo SC once on day 1. In both arms, treatment with intramuscular octreotide or placebo repeats monthly for up to 2 years in the absence of unacceptable toxicity.

Quality of life is assessed at baseline, 2 weeks, and then monthly for up to 2 years during study treatment.

After completion of study treatment, patients are followed every 6 months for up to 2 years.

Study Design

• Study Type: Interventional
• Actual Enrollment: 33 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: An Exploratory, Randomized, Placebo-Controlled Trial of Depot Octreotide (Sandostatin LARDepot) for Symptomatic Ascites in Cancer Patients
• Study Start Date: Oct 1, 2005
• Actual Primary Completion Date: Sep 1, 2009
• Actual Study Completion Date: Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm I Patients receive octreotide subcutaneously (SC) once on day 1.	Drug: octreotide acetate; Given subcutaneously
Placebo Comparator: Arm II Patients receive placebo SC once on day 1.	Other: placebo; Given subcutaneously

Outcome Measures

Primary Outcome Measures

1. Median Time to Paracentesis [Up to 2 years]

   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.

Secondary Outcome Measures

1. Number of Paracenteses [Up to 2 years]

   We will compare the number of paracenteses between groups. Parametric or nonparametric testing will be used as appropriate.

2. Average Quality-of-life [Up to 2 years]

   Quality 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';

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed cancer

• Diagnosis of malignant ascites, as determined by the treating oncologist

• Positive cytology not required

• Patient is symptomatic and views ascites as a problem

• No lymphoma or lymphomatous ascites

• Planning therapeutic paracentesis ≤ 3 days after study entry OR completed therapeutic paracentesis 2 days before study entry

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Not specified

Life expectancy

• At least 4 weeks

Hematopoietic

• Not at high risk of bleeding from a procedure

Hepatic

• No known cirrhosis or portal hypertension

Renal

• No known history of chronic renal failure, defined as creatinine ≥ 2 times upper limit of normal

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• Prior cholecystitis allowed provided patient underwent cholecystectomy

• No uncontrolled diabetes mellitus

• No known allergy to octreotide

• No known allergy to latex

• No medical condition that would preclude study treatment

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No concurrent bevacizumab

Chemotherapy

• No concurrent intraperitoneal chemotherapy

• No concurrent first-line chemotherapy for any cancer except pancreatic cancer

• Concurrent second-line chemotherapy or later-line chemotherapy allowed

Endocrine therapy

• No other concurrent octreotide

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• No concurrent therapeutic warfarin

• Concurrent prophylactic warfarin at a dose of 1 mg/day allowed

• No other concurrent treatment for ascites except paracentesis or ongoing diuretics

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aurora Presbyterian Hospital	Aurora	Colorado	United States	80012
2	Boulder Community Hospital	Boulder	Colorado	United States	80301-9019
3	Penrose Cancer Center at Penrose Hospital	Colorado Springs	Colorado	United States	80933
4	St. Anthony Central Hospital	Denver	Colorado	United States	80204
5	Porter Adventist Hospital	Denver	Colorado	United States	80210
6	Presbyterian - St. Luke's Medical Center	Denver	Colorado	United States	80218
7	St. Joseph Hospital	Denver	Colorado	United States	80218
8	Rose Medical Center	Denver	Colorado	United States	80220
9	CCOP - Colorado Cancer Research Program	Denver	Colorado	United States	80224-2522
10	Swedish Medical Center	Englewood	Colorado	United States	80110
11	St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center	Grand Junction	Colorado	United States	81502
12	North Colorado Medical Center	Greeley	Colorado	United States	80631
13	Sky Ridge Medical Center	Lone Tree	Colorado	United States	80124
14	Hope Cancer Care Center at Longmont United Hospital	Longmont	Colorado	United States	80501
15	McKee Medical Center	Loveland	Colorado	United States	80539
16	St. Mary - Corwin Regional Medical Center	Pueblo	Colorado	United States	81004
17	North Suburban Medical Center	Thornton	Colorado	United States	80229
18	Exempla Lutheran Medical Center	Wheat Ridge	Colorado	United States	80033
19	Joliet Oncology-Hematology Associates, Limited - West	Joliet	Illinois	United States	60435
20	Trinity Cancer Center at Trinity Medical Center - 7th Street Campus	Moline	Illinois	United States	61265
21		Moline	Illinois	United States	61265
22	Elkhart General Hospital	Elkhart	Indiana	United States	46515
23	Howard Community Hospital	Kokomo	Indiana	United States	46904
24	Center for Cancer Therapy at LaPorte Hospital and Health Services	La Porte	Indiana	United States	46350
25	CCOP - Northern Indiana CR Consortium	South Bend	Indiana	United States	46601
26	Memorial Hospital of South Bend	South Bend	Indiana	United States	46601
27	Saint Joseph Regional Medical Center	South Bend	Indiana	United States	46617
28	South Bend Clinic	South Bend	Indiana	United States	46617
29	McFarland Clinic, PC	Ames	Iowa	United States	50010
30		Bettendorf	Iowa	United States	52722
31	Mercy Capitol Hospital	Des Moines	Iowa	United States	50307
32	CCOP - Iowa Oncology Research Association	Des Moines	Iowa	United States	50309
33	John Stoddard Cancer Center at Iowa Methodist Medical Center	Des Moines	Iowa	United States	50309
34	Medical Oncology and Hematology Associates at John Stoddard Cancer Center	Des Moines	Iowa	United States	50309
35	Medical Oncology and Hematology Associates at Mercy Cancer Center	Des Moines	Iowa	United States	50314
36	Mercy Cancer Center at Mercy Medical Center - Des Moines	Des Moines	Iowa	United States	50314
37	John Stoddard Cancer Center at Iowa Lutheran Hospital	Des Moines	Iowa	United States	50316
38	Siouxland Hematology-Oncology Associates, LLP	Sioux City	Iowa	United States	51101
39	Mercy Medical Center - Sioux City	Sioux City	Iowa	United States	51104
40	St. Luke's Regional Medical Center	Sioux City	Iowa	United States	51104
41	Cancer Center of Kansas, PA - Chanute	Chanute	Kansas	United States	66720
42	Cancer Center of Kansas, PA - Dodge City	Dodge City	Kansas	United States	67801
43	Cancer Center of Kansas, PA - El Dorado	El Dorado	Kansas	United States	67042
44	Cancer Center of Kansas-Independence	Independence	Kansas	United States	67301
45	Cancer Center of Kansas, PA - Kingman	Kingman	Kansas	United States	67068
46	Lawrence Memorial Hospital	Lawrence	Kansas	United States	66044
47	Southwest Medical Center	Liberal	Kansas	United States	67901
48	Cancer Center of Kansas, PA - Newton	Newton	Kansas	United States	67114
49	Cancer Center of Kansas, PA - Parsons	Parsons	Kansas	United States	67357
50	Cancer Center of Kansas, PA - Pratt	Pratt	Kansas	United States	67124
51	Cancer Center of Kansas, PA - Salina	Salina	Kansas	United States	67042
52	Cancer Center of Kansas, PA - Wellington	Wellington	Kansas	United States	67152
53	Associates in Womens Health, PA - North Review	Wichita	Kansas	United States	67208
54	Cancer Center of Kansas, PA - Medical Arts Tower	Wichita	Kansas	United States	67208
55	Cancer Center of Kansas, PA - Wichita	Wichita	Kansas	United States	67214
56	CCOP - Wichita	Wichita	Kansas	United States	67214
57	Via Christi Cancer Center at Via Christi Regional Medical Center	Wichita	Kansas	United States	67214
58	Cancer Center of Kansas, PA - Winfield	Winfield	Kansas	United States	67156
59	Hickman Cancer Center at Bixby Medical Center	Adrian	Michigan	United States	49221
60	Haematology-Oncology Associates of Ohio and Michigan, PC	Lambertville	Michigan	United States	48144
61	Community Cancer Center of Monroe	Monroe	Michigan	United States	48162
62	Mercy Memorial Hospital - Monroe	Monroe	Michigan	United States	48162
63	Lakeland Regional Cancer Care Center - St. Joseph	St. Joseph	Michigan	United States	49085
64		Alexandria	Minnesota	United States	56308
65	MeritCare Bemidji	Bemidji	Minnesota	United States	56601
66	Duluth Clinic Cancer Center - Duluth	Duluth	Minnesota	United States	55805-1983
67	CCOP - Duluth	Duluth	Minnesota	United States	55805
68	Miller - Dwan Medical Center	Duluth	Minnesota	United States	55805
69		Fergus Falls	Minnesota	United States	56537
70	Immanuel St. Joseph's	Mankato	Minnesota	United States	56002
71	Mayo Clinic Cancer Center	Rochester	Minnesota	United States	55905
72	CentraCare Clinic - River Campus	Saint Cloud	Minnesota	United States	56303
73	Coborn Cancer Center	Saint Cloud	Minnesota	United States	56303
74	CCOP - Montana Cancer Consortium	Billings	Montana	United States	59101
75	Hematology-Oncology Centers of the Northern Rockies - Billings	Billings	Montana	United States	59101
76	Northern Rockies Radiation Oncology Center	Billings	Montana	United States	59101
77	St. Vincent Healthcare Cancer Care Services	Billings	Montana	United States	59101
78	Billings Clinic - Downtown	Billings	Montana	United States	59107-7000
79	St. James Healthcare Cancer Care	Butte	Montana	United States	59701
80	Great Falls Clinic - Main Facility	Great Falls	Montana	United States	59405
81		Great Falls	Montana	United States	59405
82	Northern Montana Hospital	Havre	Montana	United States	59501
83	St. Peter's Hospital	Helena	Montana	United States	59601
84	Glacier Oncology, PLLC	Kalispell	Montana	United States	59901
85	Kalispell Medical Oncology at KRMC	Kalispell	Montana	United States	59901
86	Kalispell Regional Medical Center	Kalispell	Montana	United States	59901
87	Community Medical Center	Missoula	Montana	United States	59801
88	Guardian Oncology and Center for Wellness	Missoula	Montana	United States	59804
89	Montana Cancer Specialists at Montana Cancer Center	Missoula	Montana	United States	59807-7877
90	Montana Cancer Center at St. Patrick Hospital and Health Sciences Center	Missoula	Montana	United States	59807
91	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska	United States	68106
92	Immanuel Medical Center	Omaha	Nebraska	United States	68122
93	Alegant Health Cancer Center at Bergan Mercy Medical Center	Omaha	Nebraska	United States	68124
94	Creighton University Medical Center	Omaha	Nebraska	United States	68131-2197
95	Bismarck Cancer Center	Bismarck	North Dakota	United States	58501
96	Medcenter One Hospital Cancer Care Center	Bismarck	North Dakota	United States	58501
97	Mid Dakota Clinic, PC	Bismarck	North Dakota	United States	58501
98	St. Alexius Medical Center Cancer Center	Bismarck	North Dakota	United States	58502
99	CCOP - MeritCare Hospital	Fargo	North Dakota	United States	58122
100	MeritCare Broadway	Fargo	North Dakota	United States	58122
101	Wood County Oncology Center	Bowling Green	Ohio	United States	43402
102	North Coast Cancer Care - Clyde	Clyde	Ohio	United States	43410
103	Hematology Oncology Center	Elyria	Ohio	United States	44035
104	Lima Memorial Hospital	Lima	Ohio	United States	45804
105	Northwest Ohio Oncology Center	Maumee	Ohio	United States	43537-1839
106	St. Luke's Hospital	Maumee	Ohio	United States	43537
107	St. Charles Mercy Hospital	Oregon	Ohio	United States	43616
108	Toledo Clinic - Oregon	Oregon	Ohio	United States	43616
109	North Coast Cancer Care, Incorporated	Sandusky	Ohio	United States	44870
110	Flower Hospital Cancer Center	Sylvania	Ohio	United States	43560
111	Mercy Hospital of Tiffin	Tiffin	Ohio	United States	44883
112	Toledo Hospital	Toledo	Ohio	United States	43606
113	St. Vincent Mercy Medical Center	Toledo	Ohio	United States	43608
114	Medical University of Ohio Cancer Center	Toledo	Ohio	United States	43614
115	CCOP - Toledo Community Hospital	Toledo	Ohio	United States	43617
116	St. Anne Mercy Hospital	Toledo	Ohio	United States	43623
117	Toledo Clinic, Incorporated - Main Clinic	Toledo	Ohio	United States	43623
118	Fulton County Health Center	Wauseon	Ohio	United States	43567
119	Avera Cancer Institute	Sioux Falls	South Dakota	United States	57105
120	Medical X-Ray Center, PC	Sioux Falls	South Dakota	United States	57105
121	Sanford Cancer Center at Sanford USD Medical Center	Sioux Falls	South Dakota	United States	57117-5039
122	Virginia Commonwealth University Massey Cancer Center	Richmond	Virginia	United States	23298-0037

Sponsors and Collaborators

• Alliance for Clinical Trials in Oncology
• National Cancer Institute (NCI)

Investigators

• Study Chair: Aminah Jatoi, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alliance for Clinical Trials in Oncology
• ClinicalTrials.gov Identifier: NCT00182754
• Other Study ID Numbers: NCCTG-N04C2; NCI-2009-00647; CDR0000440922
• First Posted: Sep 16, 2005
• Last Update Posted: Apr 11, 2017
• Last Verified: Feb 1, 2017

• Keywords provided by Alliance for Clinical Trials in Oncology: unspecified adult solid tumor, protocol specific; malignant ascites
• Additional relevant MeSH terms: Ascites; Octreotide

Study Results

Participant Flow

Arm/Group Title	Arm I	Arm II
Arm/Group Description	Patients receive 30 mg octreotide subcutaneously (SC) intramuscularly once on day 1. octreotide acetate: Given subcutaneously	Patients receive 2 milliliters placebo (0.9% sodium chloride) SC once on day 1. placebo: Given subcutaneously
Period Title: Overall Study
STARTED	16	17
COMPLETED	16	17
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Arm I	Arm II	Total
Arm/Group Description	Patients receive 30 mg octreotide subcutaneously (SC) intramuscularly once on day 1. octreotide acetate: Given subcutaneously	Patients receive 2 milliliters placebo (0.9% sodium chloride) SC once on day 1. placebo: Given subcutaneously	Total of all reporting groups
Overall Participants	16	17	33
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	62	69	63
Sex: Female, Male (Count of Participants)
Female	10 62.5%	12 70.6%	22 66.7%
Male	6 37.5%	5 29.4%	11 33.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 6.3%	0 0%	1 3%
Not Hispanic or Latino	14 87.5%	17 100%	31 93.9%
Unknown or Not Reported	1 6.3%	0 0%	1 3%

Outcome Measures

1. Primary Outcome

Title	Median Time to Paracentesis
Description	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.
Time Frame	Up to 2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm I	Arm II
Arm/Group Description	Patients receive 30 mg octreotide subcutaneously (SC) intramuscularly once on day 1. octreotide acetate: Given subcutaneously	Patients receive 2 milliliters placebo (0.9% sodium chloride) SC once on day 1. placebo: Given subcutaneously
Measure Participants	16	17
Median (Full Range) [days]	28	14

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I, Arm II
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.17
	Comments
	Method	Log Rank
	Comments

2. Secondary Outcome

Title	Number of Paracenteses
Description	We will compare the number of paracenteses between groups. Parametric or nonparametric testing will be used as appropriate.
Time Frame	Up to 2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm I	Arm II
Arm/Group Description	Patients receive 30 mg octreotide subcutaneously (SC) intramuscularly once on day 1. octreotide acetate: Given subcutaneously	Patients receive 2 milliliters placebo (0.9% sodium chloride) SC once on day 1. placebo: Given subcutaneously
Measure Participants	16	17
Median (Full Range) [number of paracenteses per patient]	0.5	1

3. Secondary Outcome

Title	Average Quality-of-life
Description	Quality 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';
Time Frame	Up to 2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm I	Arm II
Arm/Group Description	Patients receive 30 mg octreotide subcutaneously (SC) intramuscularly once on day 1. octreotide acetate: Given subcutaneously	Patients receive 2 milliliters placebo (0.9% sodium chloride) SC once on day 1. placebo: Given subcutaneously
Measure Participants	10	15
abdominal bloating	4	3
shortness of breath	4	3
abdominal discomfort	4.5	2

Adverse Events

Arm/Group Title	Arm I		Arm II
Arm/Group Description	Patients receive 30 mg octreotide subcutaneously (SC) intramuscularly once on day 1. octreotide acetate: Given subcutaneously		Patients receive 2 milliliters placebo (0.9% sodium chloride) SC once on day 1. placebo: Given subcutaneously
All Cause Mortality
	Arm I		Arm II
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Arm I		Arm II
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/16 (6.3%)		0/17 (0%)
Metabolism and nutrition disorders
Dehydration	1/16 (6.3%)	1	0/17 (0%)	0
Other (Not Including Serious) Adverse Events
	Arm I		Arm II
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	16/16 (100%)		16/17 (94.1%)
Blood and lymphatic system disorders
Hemoglobin decreased	1/16 (6.3%)	5	0/17 (0%)	0
Lymphatic disorder	1/16 (6.3%)	1	0/17 (0%)	0
Cardiac disorders
Atrial fibrillation	1/16 (6.3%)	1	0/17 (0%)	0
Gastrointestinal disorders
Abdominal distension	1/16 (6.3%)	1	1/17 (5.9%)	1
Abdominal pain	10/16 (62.5%)	20	12/17 (70.6%)	14
Anal fistula	1/16 (6.3%)	1	0/17 (0%)	0
Ascites	0/16 (0%)	0	1/17 (5.9%)	1
Constipation	6/16 (37.5%)	10	7/17 (41.2%)	9
Diarrhea	4/16 (25%)	14	5/17 (29.4%)	6
Nausea	4/16 (25%)	4	1/17 (5.9%)	1
Proctitis	2/16 (12.5%)	2	1/17 (5.9%)	1
Vomiting	3/16 (18.8%)	3	2/17 (11.8%)	2
General disorders
Chest pain	0/16 (0%)	0	1/17 (5.9%)	1
Death NOS	0/16 (0%)	0	1/17 (5.9%)	1
Disease progression	5/16 (31.3%)	5	3/17 (17.6%)	3
Fatigue	3/16 (18.8%)	4	2/17 (11.8%)	2
Injection site reaction	1/16 (6.3%)	2	0/17 (0%)	0
Localized edema	0/16 (0%)	0	1/17 (5.9%)	1
Hepatobiliary disorders
Cholecystitis	0/16 (0%)	0	1/17 (5.9%)	1
Hepatic failure	0/16 (0%)	0	1/17 (5.9%)	1
Injury, poisoning and procedural complications
Vascular access complication	1/16 (6.3%)	1	0/17 (0%)	0
Investigations
Activated partial thromboplastin time prolonged	1/16 (6.3%)	2	0/17 (0%)	0
Alkaline phosphatase increased	0/16 (0%)	0	1/17 (5.9%)	1
Aspartate aminotransferase increased	1/16 (6.3%)	1	0/17 (0%)	0
Blood bilirubin increased	2/16 (12.5%)	2	1/17 (5.9%)	1
Creatinine increased	1/16 (6.3%)	1	0/17 (0%)	0
Gamma-glutamyltransferase increased	0/16 (0%)	0	1/17 (5.9%)	1
Leukocyte count decreased	1/16 (6.3%)	1	0/17 (0%)	0
Neutrophil count decreased	2/16 (12.5%)	4	0/17 (0%)	0
Platelet count decreased	1/16 (6.3%)	4	0/17 (0%)	0
Weight gain	1/16 (6.3%)	1	0/17 (0%)	0
Metabolism and nutrition disorders
Anorexia	2/16 (12.5%)	2	1/17 (5.9%)	1
Blood glucose increased	2/16 (12.5%)	2	0/17 (0%)	0
Dehydration	2/16 (12.5%)	2	1/17 (5.9%)	1
Serum albumin decreased	0/16 (0%)	0	2/17 (11.8%)	2
Serum potassium decreased	1/16 (6.3%)	1	0/17 (0%)	0
Serum potassium increased	1/16 (6.3%)	1	0/17 (0%)	0
Serum sodium decreased	1/16 (6.3%)	1	1/17 (5.9%)	1
Musculoskeletal and connective tissue disorders
Back pain	0/16 (0%)	0	1/17 (5.9%)	1
Muscle weakness	0/16 (0%)	0	1/17 (5.9%)	1
Nervous system disorders
Cognitive disturbance	1/16 (6.3%)	1	0/17 (0%)	0
Dizziness	1/16 (6.3%)	1	0/17 (0%)	0
Encephalopathy	0/16 (0%)	0	1/17 (5.9%)	1
Peripheral motor neuropathy	1/16 (6.3%)	1	0/17 (0%)	0
Psychiatric disorders
Confusion	0/16 (0%)	0	1/17 (5.9%)	1
Insomnia	1/16 (6.3%)	1	0/17 (0%)	0
Respiratory, thoracic and mediastinal disorders
Dyspnea	1/16 (6.3%)	1	0/17 (0%)	0
Hypoxia	1/16 (6.3%)	1	0/17 (0%)	0
Vascular disorders
Hypotension	1/16 (6.3%)	1	0/17 (0%)	0
Vascular disorder	0/16 (0%)	0	1/17 (5.9%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE 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.