S0330 Erlotinib in Treating Patients With Unresectable or Metastatic Malignant Peripheral Nerve Sheath Tumor

• Sponsor: Southwest Oncology Group (Other)
• Overall Status: Completed
• CT.gov ID: NCT00068367
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 24
• Locations: 101
• Arm: 1
• Duration (Months): 68
• Patients Per Site: 0.2
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.

PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with unresectable or metastatic malignant peripheral nerve sheath tumor.

Condition or Disease	Intervention/Treatment	Phase
Sarcoma	Drug: erlotinib hydrochloride	Phase 2

Detailed Description

OBJECTIVES:

• Determine response (confirmed, complete, and partial) in patients with unresectable or metastatic malignant peripheral nerve sheath tumor when treated with erlotinib.

• Determine the qualitative and quantitative toxic effects of this drug in these patients.

• Correlate, preliminarily, indicators of epidermal growth factor receptor (EGFR) function (e.g., expression, phosphorylation, or markers of signal transduction downstream of EGFR) with response and progression-free and overall survival in patients treated with this drug.

• Determine the feasibility of accruing these patients in the cooperative group setting.

OUTLINE: This is a multicenter study.

Patients receive oral erlotinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients who achieve at least a confirmed partial response and become resectable undergo surgical resection (with or without radiotherapy) and then receive 2 additional courses of erlotinib. Patients with responding disease who do not become resectable continue erlotinib as above. Patients achieving a complete response (CR) receive 2 additional courses of erlotinib beyond the CR.

Patients are followed every 6 months for 2 years and then annually for 3 years.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: U.S./Canada Sarcoma Intergroup Study of OSI-774 in Malignant Peripheral Nerve Sheath Tumors, Phase II
• Study Start Date: Dec 1, 2003
• Actual Primary Completion Date: Jul 1, 2007
• Actual Study Completion Date: Aug 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm I (OSI-774) Drug: erlotinib hydrochloride Other Names: OSI-774 150 mg per day, daily until disease progression	Drug: erlotinib hydrochloride; 150 mg per day, daily until disease progression; Other Names: OSI-774

Outcome Measures

Primary Outcome Measures

1. Patients With Response (Confirmed Complete, and Partial) With Unresectable or Metastatic Malignant Peripheral Nerve Sheath Tumor When Treated With Erlotinib. [25 weeks]

   Complete response - Complete disappearance of all measurable and non-measurable disease. No new lesions, no disease related symptoms, normalization of markers and other abnormal lab values. Partial response - Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease, no new lesions.

Secondary Outcome Measures

1. Toxicity [Up to 25 weeks]

   Only adverse events that are possibly, probably or definitely related to study drug are reported.

Other Outcome Measures

1. Correlate, Preliminarily, Indicators of Epidermal Growth Factor Receptor (EGFR) Function With Response and Progression-free and Overall Survival in Patients Treated With This Drug. []

   NOT COMPLETED DUE TO EARLY CLOSURE OF STUDY

2. Feasibility of Accruing These Patients in the Cooperative Group Setting []

   NOT COMPLETED DUE TO EARLY CLOSURE OF STUDY

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 120 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed malignant peripheral nerve sheath tumor

• Malignant schwannoma or neurofibrosarcoma

• Clinical evidence of unresectable or metastatic disease

• Measurable disease

• No known current CNS metastases

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Zubrod 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count greater than 1,500/mm^3

• Platelet count greater than 100,000/mm^3

Hepatic

• Bilirubin less than 1.5 times upper limit of normal (ULN)

• SGOT or SGPT less than 1.5 times ULN (5 times ULN for patients with documented liver metastases)

Renal

• Creatinine no greater than 1.5 times ULN

• Creatinine clearance greater than 60 mL/min

Ophthalmic

• No known history of any of the following corneal diseases:

• Dry eye syndrome

• Sjögren's syndrome

• Keratoconjunctivitis sicca

• Exposure keratopathy

• Fuch's dystrophy

• No other active disorders of the cornea

Gastrointestinal

• No gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation

• No active peptic ulcer disease

• No intractable nausea or vomiting

• Able to swallow medications OR receive enteral medications via gastrostomy feeding tube

Other

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

• More than 28 days since prior biologic therapy for this malignancy

Chemotherapy

• More than 28 days since prior chemotherapy for this malignancy

Endocrine therapy

• Not specified

Radiotherapy

• More than 60 days since prior radiotherapy to the target lesion with subsequent documented progression

• More than 60 days since prior radiofrequency ablation to the target lesion with subsequent documented progression

• No concurrent radiotherapy

Surgery

• At least 3 weeks since prior major surgery and recovered

• No prior surgical procedure affecting absorption

Other

• More than 28 days since prior investigational drugs for this malignancy

• More than 60 days since prior embolization to the target lesion with subsequent documented progression

• No prior epidermal growth factor receptor-targeting therapy

• No concurrent antiretroviral therapy for HIV-positive patients

• No other concurrent investigational or commercial agents or therapies for the malignancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arkansas Cancer Research Center at University of Arkansas for Medical Sciences	Little Rock	Arkansas	United States	72205
2	University of California Davis Cancer Center	Davis	California	United States	95616
3	Contra Costa Regional Medical Center	Martinez	California	United States	94553-3156
4	St. Anthony Central Hospital	Denver	Colorado	United States	80204
5	University of Colorado Cancer Center at University of Colorado Health Sciences Center	Denver	Colorado	United States	80217-3364
6	Montrose Memorial Hospital Cancer Center	Montrose	Colorado	United States	81401
7	St. Anthony North Hospital	Westminster	Colorado	United States	80030
8	Exempla Lutheran Medical Center	Wheat Ridge	Colorado	United States	80033
9	Piedmont Hospital	Atlanta	Georgia	United States	30309
10	CCOP - Atlanta Regional	Atlanta	Georgia	United States	30342
11	Northside Hospital Cancer Center	Atlanta	Georgia	United States	30342
12	Saint Joseph's Hospital of Atlanta	Atlanta	Georgia	United States	30342
13	WellStar Cobb Hospital	Austell	Georgia	United States	30106
14	Charles B. Eberhart Cancer Center at DeKalb Medical Center	Decatur	Georgia	United States	30033
15	Gwinnett Medical Center	Lawrenceville	Georgia	United States	30045
16	Kennestone Cancer Center at Wellstar Kennestone Hospital	Marietta	Georgia	United States	30060
17	Southern Regional Medical Center	Riverdale	Georgia	United States	30274
18	Cardinal Bernardin Cancer Center at Loyola University Medical Center	Maywood	Illinois	United States	60153
19	Regional Cancer Center at Memorial Medical Center	Springfield	Illinois	United States	62781-0001
20	St. Francis Hospital and Health Centers	Beech Grove	Indiana	United States	46107
21	McFarland Clinic, P.C.	Ames	Iowa	United States	50010
22	Baton Rouge General Regional Cancer Center	Baton Rouge	Louisiana	United States	70806
23	Mary Bird Perkins Cancer Center - Baton Rouge	Baton Rouge	Louisiana	United States	70809
24	MBCCOP - LSU Health Sciences Center	New Orleans	Louisiana	United States	70112
25	Medical Center of Louisiana - New Orleans	New Orleans	Louisiana	United States	70112
26	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan	United States	48109
27	Battle Creek Health System Cancer Care Center	Battle Creek	Michigan	United States	49017
28	Mecosta County General Hospital	Big Rapids	Michigan	United States	49307
29	CCOP - Grand Rapids	Grand Rapids	Michigan	United States	49503
30	Lacks Cancer Center at Saint Mary's Mercy Medical Center	Grand Rapids	Michigan	United States	49503
31	Spectrum Health Cancer Care - Butterworth Campus	Grand Rapids	Michigan	United States	49503
32	Metropolitan Hospital	Grand Rapids	Michigan	United States	49506
33	Spectrum Health Hospital - Blodgett Campus	Grand Rapids	Michigan	United States	49506
34	Holland Community Hospital	Holland	Michigan	United States	49423
35	Hackley Hospital	Muskegon	Michigan	United States	49443
36	Northern Michigan Hospital	Petoskey	Michigan	United States	49770
37	Munson Medical Center	Traverse City	Michigan	United States	49684
38	CCOP - Montana Cancer Consortium	Billings	Montana	United States	59101
39	Deaconess Billings Clinic - Downtown	Billings	Montana	United States	59101
40	Northern Rockies Radiation Oncology Center	Billings	Montana	United States	59101
41	St. Vincent Healthcare	Billings	Montana	United States	59101
42	Deaconess Billings Clinic Cancer Center	Billings	Montana	United States	59107
43	Bozeman Deaconess Hospital	Bozeman	Montana	United States	59715
44	St. James Community Hospital	Butte	Montana	United States	59701
45	St. Peter's Hospital	Helena	Montana	United States	59601
46	Kalispell Regional Medical Center	Kalispell	Montana	United States	59901
47	Eastern Montana Cancer Center	Miles City	Montana	United States	59301
48	Community Medical Center	Missoula	Montana	United States	59801
49	Montana Cancer Center at St. Patrick Hospital and Health Sciences Center	Missoula	Montana	United States	59802
50	Methodist Cancer Center at Methodist Hospital - Omaha	Omaha	Nebraska	United States	68114
51	Blumenthal Cancer Center at Carolinas Medical Center	Charlotte	North Carolina	United States	28203
52	Wayne Memorial Hospital, Incorporated	Goldsboro	North Carolina	United States	27534
53	Wilson Medical Center	Wilson	North Carolina	United States	27893
54	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio	United States	44195
55	Grandview Hospital	Dayton	Ohio	United States	45405
56	Good Samaritan Hospital	Dayton	Ohio	United States	45406
57	David L. Rike Cancer Center at Miami Valley Hospital	Dayton	Ohio	United States	45409
58	Samaritan North Cancer Care Center	Dayton	Ohio	United States	45415
59	Veterans Affairs Medical Center - Dayton	Dayton	Ohio	United States	45428
60	CCOP - Dayton	Dayton	Ohio	United States	45429
61	Community Oncology Group - Independence	Independence	Ohio	United States	44131
62	Charles F. Kettering Memorial Hospital	Kettering	Ohio	United States	45429
63	Middletown Regional Hospital	Middletown	Ohio	United States	45044
64	UVMC Cancer Care Center at Upper Valley Medical Center	Troy	Ohio	United States	45373
65	Cleveland Clinic - Wooster	Wooster	Ohio	United States	44691
66	Ruth G. McMillan Cancer Center at Greene Memorial Hospital	Xenia	Ohio	United States	45385
67	Legacy Mount Hood Medical Center	Gresham	Oregon	United States	97030
68	Providence Milwaukie Hospital	Milwaukie	Oregon	United States	97222
69	Comprehensive Cancer Center at Legacy Good Samaritan Hospital & Medical Center	Portland	Oregon	United States	97210
70	Providence Cancer Center at Providence Portland Medical Center	Portland	Oregon	United States	97213
71	CCOP - Columbia River Oncology Program	Portland	Oregon	United States	97225
72	Providence St. Vincent Medical Center	Portland	Oregon	United States	97225
73	Institute of Oncology at Vilnius University	Portland	Oregon	United States	97227
74	Cancer Institute at Oregon Health and Science University	Portland	Oregon	United States	97239
75	Legacy Meridian Park Hospital	Tualatin	Oregon	United States	97062
76	Danville Regional Medical Center	Danville	Virginia	United States	24541
77	Auburn Regional Center for Cancer Care	Auburn	Washington	United States	98002
78	St. Joseph Hospital Community Cancer Center	Bellingham	Washington	United States	98225
79	Olympic Hematology and Oncology	Bremerton	Washington	United States	98310
80	Regional Cancer Center at Providence Hospital	Centralia	Washington	United States	98531
81	St. Francis Hospital	Federal Way	Washington	United States	98003
82	Skagit Valley Hospital Cancer Care Center	Mount Vernon	Washington	United States	98273
83	Providence St. Peter Hospital Regional Cancer Center	Olympia	Washington	United States	95806
84	Capital Medical Center	Olympia	Washington	United States	98507
85	Good Samaritan Cancer Center	Puyallup	Washington	United States	98372
86	Fred Hutchinson Cancer Research Center	Seattle	Washington	United States	98104
87	Group Health Central Hospital	Seattle	Washington	United States	98104
88	Harborview Medical Center	Seattle	Washington	United States	98104
89	Swedish Cancer Institute at Swedish Medical Center - First Hill Campus	Seattle	Washington	United States	98114
90	University Cancer Center at University of Washington Medical Center	Seattle	Washington	United States	98195
91	North Puget Oncology at United General Hospital	Sedro-Woolley	Washington	United States	98284
92	Cancer Care Northwest - Spokane South	Spokane	Washington	United States	99202
93	Allenmore Hospital	Tacoma	Washington	United States	98405
94	CCOP - Northwest	Tacoma	Washington	United States	98405
95	St. Joseph Medical Center at Franciscan Health System	Tacoma	Washington	United States	98405
96	St. Clare Hospital	Tacoma	Washington	United States	98499
97	Southwest Washington Medical Center Cancer Center	Vancouver	Washington	United States	98668
98	Central Washington Hospital	Wenatchee	Washington	United States	98801
99	Wenatchee Valley Clinic	Wenatchee	Washington	United States	98801
100	Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital	Parkersburg	West Virginia	United States	26101
101	Welch Cancer Center	Sheridan	Wyoming	United States	82801

Sponsors and Collaborators

• Southwest Oncology Group
• National Cancer Institute (NCI)

Investigators

• Study Chair: Karen H. Albritton, MD, Dana-Farber Cancer Institute
• Study Chair: R. Lor Randall, MD, FACS, University of Utah
• Study Chair: Scott M. Schuetze, MD, PhD, University of Michigan Rogel Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Southwest Oncology Group
• ClinicalTrials.gov Identifier: NCT00068367
• Other Study ID Numbers: CDR0000322023; S0330; U10CA032102
• First Posted: Sep 11, 2003
• Last Update Posted: Nov 6, 2017
• Last Verified: Oct 1, 2017

• Keywords provided by Southwest Oncology Group: adult neurofibrosarcoma; stage III adult soft tissue sarcoma; recurrent adult soft tissue sarcoma; stage II adult soft tissue sarcoma; stage IV adult soft tissue sarcoma
• Additional relevant MeSH terms: Sarcoma; Nerve Sheath Neoplasms; Neurofibrosarcoma; Erlotinib Hydrochloride

Study Results

Participant Flow

Pre-assignment Detail	Four patients enrolled to study were found to be ineligible. One patient did not have measurable disease, one patient had radiotherapy 19 days prior to registration and two patients were found ineligible upon pathology review.

Arm/Group Title	Arm I (OSI-774)
Arm/Group Description	OSI-774 150 mg daily for 25 weeks
Period Title: Overall Study
STARTED	20
COMPLETED	20
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Arm I (OSI-774)
Arm/Group Description	OSI-774 150 mg daily for 25 weeks
Overall Participants	20
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	45.3
Sex: Female, Male (Count of Participants)
Female	8 40%
Male	12 60%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 10%
Not Hispanic or Latino	16 80%
Unknown or Not Reported	2 10%
Prior multi-agent chemotherapy (Count of Participants)
Yes	14 70%
No	6 30%

Outcome Measures

1. Primary Outcome

Title	Patients With Response (Confirmed Complete, and Partial) With Unresectable or Metastatic Malignant Peripheral Nerve Sheath Tumor When Treated With Erlotinib.
Description	Complete response - Complete disappearance of all measurable and non-measurable disease. No new lesions, no disease related symptoms, normalization of markers and other abnormal lab values. Partial response - Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease, no new lesions.
Time Frame	25 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm I (OSI-774)
Arm/Group Description	OSI-774 150 mg daily for 25 weeks
Measure Participants	20
Count of Participants [Participants]	0 0%

2. Secondary Outcome

Title	Toxicity
Description	Only adverse events that are possibly, probably or definitely related to study drug are reported.
Time Frame	Up to 25 weeks

Outcome Measure Data

Analysis Population Description

All participants receiving at least some protocol treatment

Arm/Group Title	Arm I (OSI-774)
Arm/Group Description	OSI-774 150 mg daily for 25 weeks
Measure Participants	20
Anorexia	1 5%
Diarrhea	1 5%
Dyspnea (shortness of breath)	1 5%
Fatigue (asthenia, lethargy, malaise)	3 15%
Hemoglobin	1 5%
Nausea	1 5%
Pain - Abdomen NOS	1 5%
Pruritus/itching	1 5%
Rash/desquamation	1 5%
Somnolence/depressed level of consciousness	1 5%
Vision-blurred vision	1 5%

3. Other Pre-specified Outcome

Title	Correlate, Preliminarily, Indicators of Epidermal Growth Factor Receptor (EGFR) Function With Response and Progression-free and Overall Survival in Patients Treated With This Drug.
Description	NOT COMPLETED DUE TO EARLY CLOSURE OF STUDY

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm I (OSI-774)
Arm/Group Description	OSI-774 150 mg daily for 25 weeks
Measure Participants	0

4. Other Pre-specified Outcome

Title	Feasibility of Accruing These Patients in the Cooperative Group Setting
Description	NOT COMPLETED DUE TO EARLY CLOSURE OF STUDY

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	Up to 25 weeks
Arm/Group Title	Arm I (OSI-774)
Arm/Group Description	OSI-774 150 mg daily for 25 weeks
All Cause Mortality
	Arm I (OSI-774)
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Arm I (OSI-774)
	Affected / at Risk (%)	# Events
Total	12/20 (60%)
Gastrointestinal disorders
Diarrhea	1/20 (5%)
Pain - Abdomen NOS	1/20 (5%)
General disorders
Fatigue (asthenia, lethargy, malaise)	1/20 (5%)
Pain - Chest/thorax NOS	2/20 (10%)
Musculoskeletal and connective tissue disorders
Pain - Back	1/20 (5%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death - Disease progression NOS	9/20 (45%)
Nervous system disorders
Pain - Neuralgia/peripheral nerve	1/20 (5%)
Syncope (fainting)	1/20 (5%)
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)	2/20 (10%)
Hypoxia	1/20 (5%)
Other (Not Including Serious) Adverse Events
	Arm I (OSI-774)
	Affected / at Risk (%)	# Events
Total	19/20 (95%)
Blood and lymphatic system disorders
Hemoglobin	2/20 (10%)
Eye disorders
Dry eye syndrome	1/20 (5%)
Ocular/Visual-Other	2/20 (10%)
Vision-blurred vision	1/20 (5%)
Gastrointestinal disorders
Constipation	1/20 (5%)
Diarrhea	7/20 (35%)
Dry mouth/salivary gland (xerostomia)	1/20 (5%)
Hemorrhage, GI - Oral cavity	1/20 (5%)
Hemorrhage, GI - Upper GI NOS	1/20 (5%)
Mucositis/stomatitis (clinical exam) - Oral cavity	2/20 (10%)
Mucositis/stomatitis (functional/symp) - Oral cav	1/20 (5%)
Nausea	6/20 (30%)
Pain - Abdomen NOS	2/20 (10%)
Vomiting	4/20 (20%)
General disorders
Death not associated with CTCAE term - Death NOS	1/20 (5%)
Edema: head and neck	1/20 (5%)
Edema: limb	2/20 (10%)
Fatigue (asthenia, lethargy, malaise)	9/20 (45%)
Fever in absence of neutropenia, ANC lt1.0x10e9/L	2/20 (10%)
Pain - Chest/thorax NOS	1/20 (5%)
Pain-Other	1/20 (5%)
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Sinus	1/20 (5%)
Inf w/normal ANC or Gr 1-2 neutrophils - UTI	1/20 (5%)
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)	1/20 (5%)
Alkaline phosphatase	1/20 (5%)
Bilirubin (hyperbilirubinemia)	2/20 (10%)
Leukocytes (total WBC)	1/20 (5%)
Lymphopenia	2/20 (10%)
Weight loss	2/20 (10%)
Metabolism and nutrition disorders
Anorexia	7/20 (35%)
Calcium, serum-low (hypocalcemia)	1/20 (5%)
Dehydration	1/20 (5%)
Glucose, serum-high (hyperglycemia)	1/20 (5%)
Glucose, serum-low (hypoglycemia)	1/20 (5%)
Potassium, serum-low (hypokalemia)	2/20 (10%)
Sodium, serum-high (hypernatremia)	1/20 (5%)
Musculoskeletal and connective tissue disorders
Pain - Back	3/20 (15%)
Pain - Chest wall	1/20 (5%)
Pain - Extremity-limb	1/20 (5%)
Pain - Muscle	1/20 (5%)
Pain - Neck	1/20 (5%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death - Disease progression NOS	6/20 (30%)
Nervous system disorders
Dizziness	1/20 (5%)
Leak, cerebrospinal fluid (CSF)	1/20 (5%)
Neuropathy: sensory	1/20 (5%)
Ocular/Visual-Other	2/20 (10%)
Pain - Head/headache	4/20 (20%)
Pain - Neuralgia/peripheral nerve	1/20 (5%)
Somnolence/depressed level of consciousness	1/20 (5%)
Psychiatric disorders
Confusion	1/20 (5%)
Mood alteration - depression	1/20 (5%)
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis	1/20 (5%)
Cough	6/20 (30%)
Dyspnea (shortness of breath)	8/20 (40%)
Pulmonary hypertension	1/20 (5%)
Pulmonary/Upper Respiratory-Other	1/20 (5%)
Skin and subcutaneous tissue disorders
Dry skin	4/20 (20%)
Hair loss/Alopecia (scalp or body)	4/20 (20%)
Pruritus/itching	3/20 (15%)
Rash/desquamation	16/20 (80%)
Skin breakdown/decubitus ulcer	1/20 (5%)
Vascular disorders
Hemorrhage/Bleeding-Other	2/20 (10%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.