Chemoembolization in Treating Patients With Primary Liver Cancer or Metastases to the Liver

• Sponsor: Eastern Cooperative Oncology Group (Other)
• Overall Status: Completed
• CT.gov ID: NCT00003907
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 50
• Locations: 37
• Arms: 2
• Duration (Months): 156
• Patients Per Site: 1.4
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

RATIONALE: Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping chemotherapy drugs near the tumor.

PURPOSE: Phase II trial to study the effectiveness of chemoembolization in treating patients who have primary liver cancer or metastases to the liver that cannot be surgically removed.

Condition or Disease	Intervention/Treatment	Phase
Liver Cancer; Metastatic Cancer	Drug: cisplatin; Drug: doxorubicin; Drug: mitomycin; Procedure: embolization	Phase 2

Detailed Description

OBJECTIVES:

• Evaluate time to progression of disease in patients with unresectable hepatocellular carcinoma or neuroendocrine hepatic metastases undergoing chemoembolization.

• Evaluate tumor response achievable with chemoembolization in this patient population.

• Evaluate the toxicities of this treatment in these patients.

• Evaluate survival of these patients following this treatment.

• Evaluate extrahepatic patterns of failure following chemoembolization, to determine whether intrahepatic progression may be forestalled and survival affected in these patients.

• Validate a consistent method of performing chemoembolization in a multicenter setting.

OUTLINE: Patients are stratified according to disease (hepatocellular carcinoma vs neuroendocrine hepatic metastases).

Patients undergo placement of a visceral arterial catheter. Patients receive doxorubicin, mitomycin, and cisplatin as a chemoemulsion via the arterial catheter into 1 hepatic lobe only. Immediately following delivery of the chemoemulsion, particulate embolization is performed. The opposite lobe, if involved, is treated within 3-5 weeks of treatment of the initial lobe.

In the absence of unacceptable toxicity, each involved lobe is treated separately a second time, in the same sequence, beginning 8 weeks after the last lobular chemoembolization. After completion of all protocol therapy, retreatment on study of either lobe is allowed for regrowth, recurrence, or new disease, provided at least 3 months have elapsed since the initial treatment of that lobe.

Patients are followed for 5 years.

PROJECTED ACCRUAL: A total of 19-42 patients will be accrued for this study within 1 year.

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Chemoembolization in Hepatocellular Carcinoma or Neuroendocrine Hepatic Metastases: A Phase II Multi-Center Trial
• Study Start Date: Aug 1, 1999
• Actual Primary Completion Date: May 1, 2011
• Actual Study Completion Date: Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hepatocellular carcinoma Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.	Drug: cisplatin; Doxorubicin 30 mg, mitomycin 30 mg, and cisplatin 100 mg (all in powdered form) should be dissolved in 10-15 cc of contrast agent (such as isovue or optiray).; Other Names: Cis-diaminedichloroplatinum Cis-diaminedichloroplatinum (II), diaminedichloroplatinum, cis-platinum, platinum, Platinol, Platinol-AQ, DDP, CDDP, DACP, NSC 119875 ; Drug: doxorubicin; Doxorubicin 30 mg, mitomycin 30 mg, and cisplatin 100 mg (all in powdered form) should be dissolved in 10-15 cc of contrast agent (such as isovue or optiray).; Other Names: Adriamycin, Rubex, Adriamycin RDF, Adriamycin PFS, hydroxydaunorubicin, hydroxydaunomycin, ADR ; Drug: mitomycin; Doxorubicin 30 mg, mitomycin 30 mg, and cisplatin 100 mg (all in powdered form) should be dissolved in 10-15 cc of contrast agent (such as isovue or optiray).; Other Names: Mutamycin, ; Procedure: embolization; Immediately following delivery of the chemoemulsion, particulate embolization is performed. The particulate embolic material is prepared on a separate table or tray, using absorbable gelatin sponge (Gelfoam, Upjohn, Kalamazoo, MI), in either powder or pledget form. Approximately 1 g of this temporary occlusive agent is dissolved in 20-30 cc of full-strength contrast with 2.4 cc of absolute alcohol.; Other Names: trans-arterial chemoembolization, TACE
Experimental: Neuroendocrine hepatic metastases Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.	Drug: cisplatin; Doxorubicin 30 mg, mitomycin 30 mg, and cisplatin 100 mg (all in powdered form) should be dissolved in 10-15 cc of contrast agent (such as isovue or optiray).; Other Names: Cis-diaminedichloroplatinum Cis-diaminedichloroplatinum (II), diaminedichloroplatinum, cis-platinum, platinum, Platinol, Platinol-AQ, DDP, CDDP, DACP, NSC 119875 ; Drug: doxorubicin; Doxorubicin 30 mg, mitomycin 30 mg, and cisplatin 100 mg (all in powdered form) should be dissolved in 10-15 cc of contrast agent (such as isovue or optiray).; Other Names: Adriamycin, Rubex, Adriamycin RDF, Adriamycin PFS, hydroxydaunorubicin, hydroxydaunomycin, ADR ; Drug: mitomycin; Doxorubicin 30 mg, mitomycin 30 mg, and cisplatin 100 mg (all in powdered form) should be dissolved in 10-15 cc of contrast agent (such as isovue or optiray).; Other Names: Mutamycin, ; Procedure: embolization; Immediately following delivery of the chemoemulsion, particulate embolization is performed. The particulate embolic material is prepared on a separate table or tray, using absorbable gelatin sponge (Gelfoam, Upjohn, Kalamazoo, MI), in either powder or pledget form. Approximately 1 g of this temporary occlusive agent is dissolved in 20-30 cc of full-strength contrast with 2.4 cc of absolute alcohol.; Other Names: trans-arterial chemoembolization, TACE

Outcome Measures

Primary Outcome Measures

1. Time to Progression [Assessed every 3 months for 2 years, then every 6 months for 3 year.]

   Time to progression was defined as time from embolization to documented disease progression. Patients without documented progression were censored at the time of the last documented disease evaluation or of the last treatment ended, whichever was more recent.Disease progression was defined as significant increase in size of lesions or appearance of new metastatic lesions. Specifically, 1) >=25% increase in the area of any malignant lesions greater than 2 cm² or in the sum of the products of the individual lesions in a given organ site; 2)>=50% increase in the size of the product of diameters if only one lesion is available for measurement and was less than or equal to 2 cm² in size at the initiation of therapy; 3)>=25% increase in the sum of the liver measurements below the costal margins and xyphoid; 4)Appearance of new malignant lesions

Secondary Outcome Measures

1. Tumor Response [Assessed every 6 weeks]

   Clinical complete response was defined as complete disappearance of all clinically detectable malignant disease for at least 4 weeks. Partial response was defined as >= 50% decrease in tumor size for at least 4 weeks without increase in size of any area of known malignant disease of greater than 25%, or appearance of new areas of malignant disease. Tumor response was defined as complete response + partial response.

2. Overall Survival [Assessed every 3 months for 2 years, then every 6 months for 3 year.]

   Overall survival was defined as time from registration to death from any causes.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Biopsy-proven intrahepatic hepatocellular carcinoma or neuroendocrine tumor.

• Unresectable.

• Bidimensionally measurable disease by Computed Tomography (CT), Magnetic resonance imaging (MRI), or UltraSound Scanning (US) within 6 weeks of registration.

• Evidence of patent portal vasculature by Doppler US, MRI, or angiography.

• Serum total bilirubin < 2.0 mg/dl and serum creatinine < 2.0 mg/dl within 4 weeks of registration.

• Absolute neutrophil count (ANC) > 2000/µl and platelets > 50,000/µl within 4 weeks of registration.

• Expected survival of at least 3 months.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

• Age >= 18 years.

Exclusion Criteria:

• Evidence of extrahepatic disease that is likely to be life-threatening within 3 months, such as brain or symptomatic lung metastases.

• Previous intra-arterial or intra-hepatic chemotherapy or prior systemic chemotherapy within 4 weeks.

• Concurrent malignancy.

• Pregnant or breast-feeding women.

• History of life-threatening contrast allergy.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Front Range Cancer Specialists	Fort Collins	Colorado	United States	80524
2	Baptist Cancer Institute - Jacksonville	Jacksonville	Florida	United States	32207
3	Winship Cancer Institute of Emory University	Altanta	Georgia	United States	30322
4	Veterans Affairs Medical Center - Atlanta (Decatur)	Decatur	Georgia	United States	30033
5	Rush-Copley Cancer Care Center	Aurora	Illinois	United States	60507
6	Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Chicago	Illinois	United States	60611-3013
7	Hematology and Oncology Associates	Chicago	Illinois	United States	60611
8	Veterans Affairs Medical Center - Lakeside Chicago	Chicago	Illinois	United States	60611
9	Mercy Hospital and Medical Center	Chicago	Illinois	United States	60616
10	Swedish Covenant Hospital	Chicago	Illinois	United States	60625
11	Hinsdale Hematology Oncology Associates	Hinsdale	Illinois	United States	60521
12	Midwest Center for Hematology/Oncology	Joliet	Illinois	United States	60432
13	Joliet Oncology-Hematology Associates, Limited - West	Joliet	Illinois	United States	60435
14	North Shore Oncology and Hematology Associates, Limited - Libertyville	Libertyville	Illinois	United States	60048
15	Hematology Oncology Associates - Skokie	Skokie	Illinois	United States	60076
16	Hematology/Oncology of the North Shore at Gross Point Medical Center	Skokie	Illinois	United States	60076
17	Carle Cancer Center at Carle Foundation Hospital	Urbana	Illinois	United States	61801
18	CCOP - Carle Cancer Center	Urbana	Illinois	United States	61801
19	Saint Anthony Memorial Health Centers	Michigan City	Indiana	United States	46360
20	Mercy Capitol Hospital	Des Moines	Iowa	United States	50307
21	CCOP - Iowa Oncology Research Association	Des Moines	Iowa	United States	50309
22	John Stoddard Cancer Center at Iowa Methodist Medical Center	Des Moines	Iowa	United States	50309
23	Medical Oncology and Hematology Associates at John Stoddard Cancer Center	Des Moines	Iowa	United States	50309
24	Medical Oncology and Hematology Associates at Mercy Cancer Center	Des Moines	Iowa	United States	50314
25	Mercy Cancer Center at Mercy Medical Center - Des Moines	Des Moines	Iowa	United States	50314
26	John Stoddard Cancer Center at Iowa Lutheran Hospital	Des Moines	Iowa	United States	50316-2301
27	Medical Oncology and Hematology Associates - West Des Moines	West Des Moines	Iowa	United States	50266
28	Borgess Medical Center	Kalamazooaa	Michigan	United States	49001
29	West Michigan Cancer Center	Kalamazoo	Michigan	United States	49007-3731
30	Bronson Methodist Hospital	Kalamazoo	Michigan	United States	49007
31	Carol G. Simon Cancer Center at Morristown Memorial Hospital	Morristown	New Jersey	United States	07962
32	Somerset Medical Center	Somerville	New Jersey	United States	08876
33	Overlook Hospital	Summit	New Jersey	United States	07902
34	Case Comprehensive Cancer Center	Cleveland	Ohio	United States	44106
35	St. Rita's Medical Center	Lima	Ohio	United States	45801
36	Fox Chase Cancer Center - Philadelphia	Philadelphia	Pennsylvania	United States	19111-2497
37	Albert Einstein Cancer Center	Philadelphia	Pennsylvania	United States	19141

Sponsors and Collaborators

• Eastern Cooperative Oncology Group
• National Cancer Institute (NCI)

Investigators

• Study Chair: Keith E. Stuart, MD, Beth Israel Deaconess Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eastern Cooperative Oncology Group
• ClinicalTrials.gov Identifier: NCT00003907
• Other Study ID Numbers: CDR0000067083; U10CA021115; E4298
• First Posted: Oct 9, 2003
• Last Update Posted: Feb 15, 2013
• Last Verified: Feb 1, 2013

• Keywords provided by Eastern Cooperative Oncology Group: localized unresectable adult primary liver cancer; advanced adult primary liver cancer; recurrent adult primary liver cancer; adult primary hepatocellular carcinoma; liver metastases
• Additional relevant MeSH terms: Neoplasm Metastasis; Liver Neoplasms; Cisplatin; Doxorubicin; Liposomal doxorubicin; Mitomycins; Mitomycin

Study Results

Participant Flow

Recruitment Details	Participants were recruited from ECOG membership institution between August 6, 1999 and September 15, 2006.

Arm/Group Title	Hepatocellular Carcinoma	Neuroendocrine Hepatic Metastases
Arm/Group Description	Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.	Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
Period Title: Overall Study
STARTED	19	31
Eligible	18	29
Received Protocol Therapy (Treated)	18	31
Eligible and Treated	17	29
COMPLETED	6	8
NOT COMPLETED	13	23

Baseline Characteristics

Arm/Group Title	Hepatocellular Carcinoma	Neuroendocrine Hepatic Metastases	Total
Arm/Group Description	Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.	Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.	Total of all reporting groups
Overall Participants	17	29	46
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	62	62	62
Sex: Female, Male (Count of Participants)
Female	4 23.5%	15 51.7%	19 41.3%
Male	13 76.5%	14 48.3%	27 58.7%
Region of Enrollment (participants) [Number]
United States	17 100%	29 100%	46 100%

Outcome Measures

1. Primary Outcome

Title	Time to Progression
Description	Time to progression was defined as time from embolization to documented disease progression. Patients without documented progression were censored at the time of the last documented disease evaluation or of the last treatment ended, whichever was more recent.Disease progression was defined as significant increase in size of lesions or appearance of new metastatic lesions. Specifically, 1) >=25% increase in the area of any malignant lesions greater than 2 cm² or in the sum of the products of the individual lesions in a given organ site; 2)>=50% increase in the size of the product of diameters if only one lesion is available for measurement and was less than or equal to 2 cm² in size at the initiation of therapy; 3)>=25% increase in the sum of the liver measurements below the costal margins and xyphoid; 4)Appearance of new malignant lesions
Time Frame	Assessed every 3 months for 2 years, then every 6 months for 3 year.

Outcome Measure Data

Analysis Population Description

All eligible and treated patients

Arm/Group Title	Hepatocellular Carcinoma	Neuroendocrine Hepatic Metastases
Arm/Group Description	Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.	Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
Measure Participants	17	29
Median (90% Confidence Interval) [Months]	2.3	7.2

2. Secondary Outcome

Title	Tumor Response
Description	Clinical complete response was defined as complete disappearance of all clinically detectable malignant disease for at least 4 weeks. Partial response was defined as >= 50% decrease in tumor size for at least 4 weeks without increase in size of any area of known malignant disease of greater than 25%, or appearance of new areas of malignant disease. Tumor response was defined as complete response + partial response.
Time Frame	Assessed every 6 weeks

Outcome Measure Data

Analysis Population Description

all eligible and treated patients

Arm/Group Title	Hepatocellular Carcinoma	Neuroendocrine Hepatic Metastases
Arm/Group Description	Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.	Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
Measure Participants	17	29
Number (90% Confidence Interval) [Proportion of participants]	0 0%	0.17 0.6%

3. Secondary Outcome

Title	Overall Survival
Description	Overall survival was defined as time from registration to death from any causes.
Time Frame	Assessed every 3 months for 2 years, then every 6 months for 3 year.

Outcome Measure Data

Analysis Population Description

all eligible and treated patients

Arm/Group Title	Hepatocellular Carcinoma	Neuroendocrine Hepatic Metastases
Arm/Group Description	Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.	Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
Measure Participants	17	29
Median (90% Confidence Interval) [Months]	12.0	21.2

Adverse Events

Time Frame	Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
Arm/Group Title	Hepatocellular Carcinoma		Neuroendocrine Hepatic Metastases
Arm/Group Description	Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.		Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
All Cause Mortality
	Hepatocellular Carcinoma		Neuroendocrine Hepatic Metastases
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Hepatocellular Carcinoma		Neuroendocrine Hepatic Metastases
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	18/18 (100%)		30/31 (96.8%)
Blood and lymphatic system disorders
Anemia	0/18 (0%)		4/31 (12.9%)
Transfusion: pRBCs	0/18 (0%)		1/31 (3.2%)
Cardiac disorders
Sinus tachycardia	0/18 (0%)		1/31 (3.2%)
Supraventricular arrhythmias	0/18 (0%)		1/31 (3.2%)
Cardiac-ischemia	0/18 (0%)		1/31 (3.2%)
Gastrointestinal disorders
Colitis	1/18 (5.6%)		0/31 (0%)
Constipation	1/18 (5.6%)		1/31 (3.2%)
Dyspepsia	0/18 (0%)		1/31 (3.2%)
Ileus	0/18 (0%)		2/31 (6.5%)
Nausea	0/18 (0%)		7/31 (22.6%)
Vomiting	0/18 (0%)		1/31 (3.2%)
GI-other	0/18 (0%)		1/31 (3.2%)
Melena/GI bleeding	1/18 (5.6%)		1/31 (3.2%)
Abdominal pain	0/18 (0%)		5/31 (16.1%)
General disorders
Fatigue	2/18 (11.1%)		4/31 (12.9%)
Fever	1/18 (5.6%)		0/31 (0%)
Hepatobiliary disorders
Hepatic enlargement	0/18 (0%)		1/31 (3.2%)
Liver dysfunction/failure	2/18 (11.1%)		2/31 (6.5%)
Hepatic-other	0/18 (0%)		3/31 (9.7%)
Hepatic pain	0/18 (0%)		1/31 (3.2%)
Infections and infestations
Infection w/o neutropenia	1/18 (5.6%)		1/31 (3.2%)
Infection-other	1/18 (5.6%)		0/31 (0%)
Injury, poisoning and procedural complications
Operative injury of vein/artery	0/18 (0%)		2/31 (6.5%)
Investigations
Neutropenia (Neutrophils, decreased)	1/18 (5.6%)		2/31 (6.5%)
Thrombocytopenia (Platelets, decreased)	2/18 (11.1%)		0/31 (0%)
Weight gain	2/18 (11.1%)		0/31 (0%)
PT	1/18 (5.6%)		1/31 (3.2%)
Alkaline phosphatase	1/18 (5.6%)		3/31 (9.7%)
Bilirubin	4/18 (22.2%)		1/31 (3.2%)
SGOT	18/18 (100%)		26/31 (83.9%)
SGPT	0/18 (0%)		6/31 (19.4%)
Hypercholesterolemia	0/18 (0%)		1/31 (3.2%)
Creatinine	1/18 (5.6%)		2/31 (6.5%)
Metabolism and nutrition disorders
Anorexia	1/18 (5.6%)		2/31 (6.5%)
Dehydration	0/18 (0%)		1/31 (3.2%)
Hypoalbuminemia	3/18 (16.7%)		4/31 (12.9%)
Hyperglycemia	0/18 (0%)		1/31 (3.2%)
Hypocalcemia	0/18 (0%)		1/31 (3.2%)
Hypokalemia	0/18 (0%)		1/31 (3.2%)
Hypophosphatemia	0/18 (0%)		1/31 (3.2%)
Tumor lysis syndrome	1/18 (5.6%)		0/31 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain	0/18 (0%)		1/31 (3.2%)
Nervous system disorders
Arachnoiditis	0/18 (0%)		1/31 (3.2%)
Dizziness/lightheadedness	0/18 (0%)		1/31 (3.2%)
Psychiatric disorders
Confusion	0/18 (0%)		1/31 (3.2%)
Renal and urinary disorders
Renal failure	2/18 (11.1%)		0/31 (0%)
Respiratory, thoracic and mediastinal disorders
Hypoxia	0/18 (0%)		1/31 (3.2%)
Skin and subcutaneous tissue disorders
Pruritus	1/18 (5.6%)		0/31 (0%)
Vascular disorders
Acute vascular leak syndrome	0/18 (0%)		1/31 (3.2%)
Hypertension	0/18 (0%)		3/31 (9.7%)
Hypotension	0/18 (0%)		1/31 (3.2%)
Hemorrhage with grade 3 or 4 platelets	1/18 (5.6%)		0/31 (0%)
Other (Not Including Serious) Adverse Events
	Hepatocellular Carcinoma		Neuroendocrine Hepatic Metastases
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	18/18 (100%)		31/31 (100%)
Blood and lymphatic system disorders
Anemia	16/18 (88.9%)		21/31 (67.7%)
Gastrointestinal disorders
Ascites	2/18 (11.1%)		1/31 (3.2%)
Constipation	1/18 (5.6%)		4/31 (12.9%)
Nausea	10/18 (55.6%)		21/31 (67.7%)
Vomiting	7/18 (38.9%)		21/31 (67.7%)
Diarrhea w/o prior colostomy	1/18 (5.6%)		8/31 (25.8%)
Abdominal pain	1/18 (5.6%)		13/31 (41.9%)
General disorders
Fatigue	9/18 (50%)		16/31 (51.6%)
Fever	7/18 (38.9%)		9/31 (29%)
Rigors/chills	1/18 (5.6%)		3/31 (9.7%)
Pain-other	3/18 (16.7%)		1/31 (3.2%)
Hepatobiliary disorders
Hepatic pain	2/18 (11.1%)		1/31 (3.2%)
Investigations
Leukopenia (Leukocytes, decreased)	3/18 (16.7%)		7/31 (22.6%)
Neutropenia (Neutrophils, decreased)	0/18 (0%)		6/31 (19.4%)
Thrombocytopenia (Platelets, decreased)	11/18 (61.1%)		14/31 (45.2%)
Weight loss	3/18 (16.7%)		11/31 (35.5%)
PT	10/18 (55.6%)		9/31 (29%)
Alkaline phosphatase	15/18 (83.3%)		24/31 (77.4%)
Bilirubin	7/18 (38.9%)		10/31 (32.3%)
Creatinine	3/18 (16.7%)		1/31 (3.2%)
Metabolism and nutrition disorders
Anorexia	4/18 (22.2%)		13/31 (41.9%)
Dehydration	1/18 (5.6%)		2/31 (6.5%)
Hypoalbuminemia	12/18 (66.7%)		17/31 (54.8%)
Skin and subcutaneous tissue disorders
Edema	2/18 (11.1%)		1/31 (3.2%)
Alopecia	1/18 (5.6%)		3/31 (9.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT 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.