S0618 E7389 in Treating Patients With Metastatic or Recurrent Head and Neck Cancer

• Sponsor: National Cancer Institute (NCI) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT00337129
• Collaborator: (none)
• Enrollment: 42
• Locations: 139
• Arm: 1
• Duration (Months): 62
• Patients Per Site: 0.3
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as E7389, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well E7389 works in treating patients with metastatic or recurrent head and neck cancer.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer	Drug: eribulin mesylate	Phase 2

Detailed Description

OBJECTIVES:

• Evaluate the response probability (confirmed, complete, and partial responses) in patients with metastatic or recurrent squamous cell carcinoma of the head and neck treated with E7389.

• Estimate progression-free and overall survival probability in these patients.

• Evaluate the qualitative and quantitative toxicities of this treatment regimen.

OUTLINE: This is a multicenter study.

Patients receive E7389 IV on days 1 and 8. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression.

After completion of study treatment, patients are followed periodically for up to 3 years.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 42 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Evaluation of E7389 (NSC-707389) in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck
• Study Start Date: May 1, 2006
• Actual Primary Completion Date: Aug 1, 2008
• Actual Study Completion Date: Jul 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: eribulin mesylate eribulin mesylate	Drug: eribulin mesylate; 1.4 mg/m2 by IV bolus on Days 1 and 8 of an every 21-day cycle.; Other Names: E7389

Outcome Measures

Primary Outcome Measures

1. Response Probability (Confirmed Complete and Partial Responses) [Every 6 weeks until progression of disease up to a maximum of 3 years after registration]

   Response was defined per RECIST. Complete response (CR) was defined as complete disappearance of all baseline measurable and non-measurable disease with no new lesions. Partial response (PR) was defined as at least 30% decrease under baseline of the sum of longest diameters of all target measurable lesions with no unequivocal progression of non-measurable disease and no new lesions. A CR or PR must be confirmed by a second determination at least 4 weeks apart. All disease must have been assessed using the same technique as baseline.

Secondary Outcome Measures

1. Progression-Free Survival [Every 6 weeks until progression of disease up to a maximum of 3 years after registration.]

   Progression-free survival was defined as the time from date of registration to the date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free were censored at date of last contact.

2. Overall Survival [Every 3 months for first year, then every six months thereafter up to a maximum of 3 years from registration.]

   Overall survival was defined as the time from the date of registration to the date of death due to any cause. Patients last known to be alive are censored at date of last contact.

3. Participants With a Given Type of AE [Every 3 weeks while on protocol therapy, up to 3 years.]

   The NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 3.0 was utilized.

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 squamous cell carcinoma of the head and neck (SCCHN)

• Disease is either metastatic at diagnosis or has persisted, metastasized, or recurred after definitive surgery and/or radiotherapy

• Not amenable to surgical resection for salvage therapy

• No newly diagnosed nonmetastatic disease

• No salivary or nasopharyngeal primary disease

• Patients who have failed primary surgery alone, and who have disease that is salvageable by radiation or chemoradiation, are not eligible

• Measurable disease

• Measurable disease within a previous radiotherapy port must demonstrate clearly progressive disease

• No active or prior CNS metastasis

PATIENT CHARACTERISTICS:

• Zubrod performance status 0-1

• Absolute granulocyte count ≥ 1,500/mm³

• Platelet count ≥ 100,000/mm³

• Bilirubin ≤ 2 times upper limit of normal (ULN)

• SGOT and SGPT ≤ 2 times ULN

• Creatinine ≤ 2 times ULN

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No known HIV positivity

• No prior malignancies except for the following:

• Adequately treated basal cell or squamous cell skin cancer

• In situ cervical cancer

• Adequately treated stage I or II cancer currently in complete remission

• Any other cancer for which the patient has been disease free for ≥ 5 years

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior chemotherapy for recurrent or newly diagnosed metastatic disease

• At least 6 months since prior induction or adjuvant chemotherapy for patients who relapsed after receiving this therapy

• No more than 1 prior induction or adjuvant regimen (may have included a taxane)

• More than 2 weeks since prior biologic therapy (i.e., epidermal growth factor inhibitors and vascular endothelial growth factor inhibitors)

• More than 28 days since prior radiotherapy and recovered

• More than 28 days since prior surgery and recovered

• No other concurrent therapy (i.e., radiotherapy, chemotherapy, immunotherapy, biologic therapy, or gene therapy) for SCCHN

• No concurrent combination antiretroviral therapy for HIV-positive patients

• No concurrent prophylactic colony-stimulating factors during course 1

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alaska Regional Hospital Cancer Center	Anchorage	Alaska	United States	99508
2	Arkansas Cancer Research Center at University of Arkansas for Medical Sciences	Little Rock	Arkansas	United States	72205
3	Providence Saint Joseph Medical Center - Burbank	Burbank	California	United States	91505
4	City of Hope Comprehensive Cancer Center	Duarte	California	United States	91010-3000
5	Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center	Orange	California	United States	92868
6	Broward General Medical Center Cancer Center	Fort Lauderdale	Florida	United States	33316
7	M.D. Anderson Cancer Center at Orlando	Orlando	Florida	United States	32806
8	Northeast Georgia Medical Center	Gainesville	Georgia	United States	30501
9	Pearlman Comprehensive Cancer Center at South Georgia Medical Center	Valdosta	Georgia	United States	31603
10	St. Francis Hospital and Health Centers - Beech Grove Campus	Beech Grove	Indiana	United States	46107
11	Reid Hospital & Health Care Services	Richmond	Indiana	United States	47374
12	Cancer Center of Kansas, PA - Chanute	Chanute	Kansas	United States	66720
13	Cancer Center of Kansas, PA - Dodge City	Dodge City	Kansas	United States	67801
14	Cancer Center of Kansas, PA - El Dorado	El Dorado	Kansas	United States	67042
15	Cancer Center of Kansas, PA - Kingman	Kingman	Kansas	United States	67068
16	Southwest Medical Center	Liberal	Kansas	United States	67901
17	Cancer Center of Kansas, PA - Newton	Newton	Kansas	United States	67114
18	Cancer Center of Kansas, PA - Parsons	Parsons	Kansas	United States	67357
19	Cancer Center of Kansas, PA - Pratt	Pratt	Kansas	United States	67124
20	Cancer Center of Kansas, PA - Salina	Salina	Kansas	United States	67042
21	Tammy Walker Cancer Center at Salina Regional Health Center	Salina	Kansas	United States	67401
22	Cancer Center of Kansas, PA - Wellington	Wellington	Kansas	United States	67152
23	Associates in Womens Health, PA - North Review	Wichita	Kansas	United States	67203
24	Cancer Center of Kansas, PA - Medical Arts Tower	Wichita	Kansas	United States	67208
25	Cancer Center of Kansas, PA - Wichita	Wichita	Kansas	United States	67214
26	CCOP - Wichita	Wichita	Kansas	United States	67214
27	Via Christi Cancer Center at Via Christi Regional Medical Center	Wichita	Kansas	United States	67214
28	Cancer Center of Kansas, PA - Winfield	Winfield	Kansas	United States	67156
29	Lucille P. Markey Cancer Center at University of Kentucky	Lexington	Kentucky	United States	40536-0093
30	Boston University Cancer Research Center	Boston	Massachusetts	United States	02118
31	Saint Joseph Mercy Cancer Center	Ann Arbor	Michigan	United States	48106-0995
32	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan	United States	48106
33	Battle Creek Health System Cancer Care Center	Battle Creek	Michigan	United States	49017
34	Mecosta County Medical Center	Big Rapids	Michigan	United States	49307
35	Oakwood Cancer Center at Oakwood Hospital and Medical Center	Dearborn	Michigan	United States	48123-2500
36	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan	United States	48201-1379
37	Genesys Hurley Cancer Institute	Flint	Michigan	United States	48503
38	Hurley Medical Center	Flint	Michigan	United States	48503
39	Butterworth Hospital at Spectrum Health	Grand Rapids	Michigan	United States	49503
40	CCOP - Grand Rapids	Grand Rapids	Michigan	United States	49503
41	Lacks Cancer Center at Saint Mary's Health Care	Grand Rapids	Michigan	United States	49503
42	Metro Health Hospital	Grand Rapids	Michigan	United States	49506
43	Van Elslander Cancer Center at St. John Hospital and Medical Center	Grosse Pointe Woods	Michigan	United States	48236
44	Holland Community Hospital	Holland	Michigan	United States	49423
45	Foote Memorial Hospital	Jackson	Michigan	United States	49201
46	Sparrow Regional Cancer Center	Lansing	Michigan	United States	48912-1811
47	Hackley Hospital	Muskegon	Michigan	United States	49442
48	Seton Cancer Institute at Saint Mary's - Saginaw	Saginaw	Michigan	United States	48601
49	Munson Medical Center	Traverse City	Michigan	United States	49684
50	St. John Macomb Hospital	Warren	Michigan	United States	48093
51	University of Mississippi Cancer Clinic	Jackson	Mississippi	United States	39216
52	CCOP - Cancer Research for the Ozarks	Springfield	Missouri	United States	65802
53	St. John's Regional Health Center	Springfield	Missouri	United States	65804
54	Hulston Cancer Center at Cox Medical Center South	Springfield	Missouri	United States	65807
55	CCOP - Montana Cancer Consortium	Billings	Montana	United States	59101
56	Hematology-Oncology Centers of the Northern Rockies - Billings	Billings	Montana	United States	59101
57	Northern Rockies Radiation Oncology Center	Billings	Montana	United States	59101
58	St. Vincent Healthcare Cancer Care Services	Billings	Montana	United States	59101
59	Billings Clinic - Downtown	Billings	Montana	United States	59107-7000
60	Bozeman Deaconess Cancer Center	Bozeman	Montana	United States	59715
61	St. James Healthcare Cancer Care	Butte	Montana	United States	59701
62	Great Falls Clinic - Main Facility	Great Falls	Montana	United States	59405
63		Great Falls	Montana	United States	59405
64	St. Peter's Hospital	Helena	Montana	United States	59601
65	Glacier Oncology, PLLC	Kalispell	Montana	United States	59901
66	Kalispell Medical Oncology at KRMC	Kalispell	Montana	United States	59901
67	Kalispell Regional Medical Center	Kalispell	Montana	United States	59901
68	Community Medical Center	Missoula	Montana	United States	59801
69	Guardian Oncology and Center for Wellness	Missoula	Montana	United States	59804
70	Montana Cancer Specialists at Montana Cancer Center	Missoula	Montana	United States	59807-7877
71	Montana Cancer Center at St. Patrick Hospital and Health Sciences Center	Missoula	Montana	United States	59807
72	Hematology Oncology Associates, PC	Albuquerque	New Mexico	United States	87106
73	Veterans Affairs Medical Center - Albuquerque	Albuquerque	New Mexico	United States	87108-5128
74	University of New Mexico Cancer Center	Albuquerque	New Mexico	United States	87131-5636
75	New Mexico Cancer Care Associates	Santa Fe	New Mexico	United States	87505
76	Tucker Center for Cancer Care at Orange Regional Medical Center	Middletown	New York	United States	10940-4199
77	Interlakes Oncology/Hematology PC	Rochester	New York	United States	14623
78	James P. Wilmot Cancer Center at University of Rochester Medical Center	Rochester	New York	United States	14642
79	Wayne Memorial Hospital, Incorporated	Goldsboro	North Carolina	United States	27534
80	Rutherford Hospital	Rutherfordton	North Carolina	United States	28139
81	McDowell Cancer Center at Akron General Medical Center	Akron	Ohio	United States	44307
82	Grandview Hospital	Dayton	Ohio	United States	45405
83	Good Samaritan Hospital	Dayton	Ohio	United States	45406
84	David L. Rike Cancer Center at Miami Valley Hospital	Dayton	Ohio	United States	45409
85	Samaritan North Cancer Care Center	Dayton	Ohio	United States	45415
86	Veterans Affairs Medical Center - Dayton	Dayton	Ohio	United States	45428
87	CCOP - Dayton	Dayton	Ohio	United States	45429
88	Blanchard Valley Medical Associates	Findlay	Ohio	United States	45840
89	Charles F. Kettering Memorial Hospital	Kettering	Ohio	United States	45429
90	Middletown Regional Hospital	Middletown	Ohio	United States	45044
91	UVMC Cancer Care Center at Upper Valley Medical Center	Troy	Ohio	United States	45373-1300
92	Ruth G. McMillan Cancer Center at Greene Memorial Hospital	Xenia	Ohio	United States	45385
93	Oklahoma University Cancer Institute	Oklahoma City	Oklahoma	United States	73104
94	Bay Area Hospital	Coos Bay	Oregon	United States	97420
95	Legacy Mount Hood Medical Center	Gresham	Oregon	United States	97030
96	Providence Milwaukie Hospital	Milwaukie	Oregon	United States	97222
97	Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center	Portland	Oregon	United States	97210
98	Providence Cancer Center at Providence Portland Medical Center	Portland	Oregon	United States	97213-2967
99	Adventist Medical Center	Portland	Oregon	United States	97216
100	CCOP - Columbia River Oncology Program	Portland	Oregon	United States	97225
101	Providence St. Vincent Medical Center	Portland	Oregon	United States	97225
102	Legacy Emanuel Hospital and Health Center & Children's Hospital	Portland	Oregon	United States	97227
103	Salem Hospital Regional Cancer Care Services	Salem	Oregon	United States	97309-5014
104	Legacy Meridian Park Hospital	Tualatin	Oregon	United States	97062
105	AnMed Cancer Center	Anderson	South Carolina	United States	29621
106	CCOP - Upstate Carolina	Spartanburg	South Carolina	United States	29303
107	Gibbs Regional Cancer Center at Spartanburg Regional Medical Center	Spartanburg	South Carolina	United States	29303
108	U.T. Cancer Institute at University of Tennessee Medical Center	Knoxville	Tennessee	United States	37920-6999
109	Harrington Cancer Center	Amarillo	Texas	United States	79106
110	Medical City Dallas Hospital	Dallas	Texas	United States	75230
111	American Fork Hospital	American Fork	Utah	United States	84003
112	Sandra L. Maxwell Cancer Center	Cedar City	Utah	United States	84720
113	Logan Regional Hospital	Logan	Utah	United States	84321
114	Cottonwood Hospital Medical Center	Murray	Utah	United States	84107
115	Jon and Karen Huntsman Cancer Center at Intermountain Medical Center	Murray	Utah	United States	84157
116	Val and Ann Browning Cancer Center at McKay-Dee Hospital Center	Ogden	Utah	United States	84403
117	Utah Valley Regional Medical Center - Provo	Provo	Utah	United States	84604
118	Dixie Regional Medical Center - East Campus	Saint George	Utah	United States	84770
119	Latter Day Saints Hospital	Salt Lake City	Utah	United States	84103
120	Utah Cancer Specialists at UCS Cancer Center	Salt Lake City	Utah	United States	84106
121	Danville Regional Medical Center	Danville	Virginia	United States	24541
122	Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County	Martinsville	Virginia	United States	24115
123	St. Joseph Cancer Center	Bellingham	Washington	United States	98225
124	Olympic Hematology and Oncology	Bremerton	Washington	United States	98310
125	Columbia Basin Hematology	Kennewick	Washington	United States	99336
126	Skagit Valley Hospital Cancer Care Center	Mt. Vernon	Washington	United States	98273
127	Fred Hutchinson Cancer Research Center	Seattle	Washington	United States	98104
128	Harborview Medical Center	Seattle	Washington	United States	98104
129	Minor and James Medical, PLLC	Seattle	Washington	United States	98104
130	Group Health Central Hospital	Seattle	Washington	United States	98112
131	Swedish Cancer Institute at Swedish Medical Center - First Hill Campus	Seattle	Washington	United States	98122-4307
132	Polyclinic First Hill	Seattle	Washington	United States	98122
133	University Cancer Center at University of Washington Medical Center	Seattle	Washington	United States	98195-6043
134	Cancer Care Northwest - Spokane South	Spokane	Washington	United States	99202
135	Providence Cancer Center at Sacred Heart Medical Center	Spokane	Washington	United States	99204
136	Providence Cancer Center at Holy Family Hospital	Spokane	Washington	United States	99207
137	Southwest Washington Medical Center Cancer Center	Vancouver	Washington	United States	98668
138	Wenatchee Valley Medical Center	Wenatchee	Washington	United States	98801-2028
139	Welch Cancer Center at Sheridan Memorial Hospital	Sheridan	Wyoming	United States	82801

Sponsors and Collaborators

• National Cancer Institute (NCI)

Investigators

• Study Chair: Susanne M. Arnold, MD, Lucille P. Markey Cancer Center at University of Kentucky

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Cancer Institute (NCI)
• ClinicalTrials.gov Identifier: NCT00337129
• Other Study ID Numbers: NCI-2012-03046; U10CA032102; S0618; CDR0000481530
• First Posted: Jun 15, 2006
• Last Update Posted: Aug 25, 2015
• Last Verified: Jul 1, 2012

• Keywords provided by National Cancer Institute (NCI): metastatic squamous neck cancer with occult primary squamous cell carcinoma; recurrent metastatic squamous neck cancer with occult primary; recurrent squamous cell carcinoma of the hypopharynx; recurrent squamous cell carcinoma of the larynx; recurrent squamous cell carcinoma of the lip and oral cavity; recurrent squamous cell carcinoma of the oropharynx; recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity; stage IV squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the larynx; stage IV squamous cell carcinoma of the lip and oral cavity; stage IV squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity; untreated metastatic squamous neck cancer with occult primary; salivary gland squamous cell carcinoma
• Additional relevant MeSH terms: Head and Neck Neoplasms

Study Results

Participant Flow

Recruitment Details	From June 2006 to December, 2007 a total of 42 patients were enrolled from SWOG institutions
Pre-assignment Detail	2 patients are not eligible before assignment.

Arm/Group Title	Treatment (E7389 IV)
Arm/Group Description	Patients receive E7389 IV on days 1 and 8 of an every 21-day cycle.
Period Title: Overall Study
STARTED	40
COMPLETED	0
NOT COMPLETED	40

Baseline Characteristics

Arm/Group Title	Treatment (E7389 IV)
Arm/Group Description	Patients receive E7389 IV on days 1 and 8 of an every 21-day cycle.
Overall Participants	40
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	61
Sex: Female, Male (Count of Participants)
Female	11 27.5%
Male	29 72.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	1 2.5%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	5 12.5%
White	33 82.5%
More than one race	0 0%
Unknown or Not Reported	1 2.5%

Outcome Measures

1. Primary Outcome

Title	Response Probability (Confirmed Complete and Partial Responses)
Description	Response was defined per RECIST. Complete response (CR) was defined as complete disappearance of all baseline measurable and non-measurable disease with no new lesions. Partial response (PR) was defined as at least 30% decrease under baseline of the sum of longest diameters of all target measurable lesions with no unequivocal progression of non-measurable disease and no new lesions. A CR or PR must be confirmed by a second determination at least 4 weeks apart. All disease must have been assessed using the same technique as baseline.
Time Frame	Every 6 weeks until progression of disease up to a maximum of 3 years after registration

Outcome Measure Data

Analysis Population Description

Only eligible patients were included in the analysis

Arm/Group Title	Treatment (E7389 IV)
Arm/Group Description	Patients receive E7389 IV on days 1 and 8 of an every 21-day cycle.
Measure Participants	40
Complete Response	0 0%
Partial Response	2 5%
No Response	38 95%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Treatment (E7389 IV)
	Comments	Null hypothesis: response probability < 5%; alternative hypothesis: response probability > 20%. A two-stage design was used. If no responses among the first 20 patients, the study would be terminated with the conclusion that E7389 is inactive. However, if at least one response was seen then an additional 20 patients would be accrued. Five or more responses out of 40 would be considered evidence that E7389 warranted further study. This design had a significance level of 5% and a power of 92%.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Response probability
	Estimated Value	0.05
	Confidence Interval	(2-Sided) 95%; 0.01 to 0.17
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Progression-Free Survival
Description	Progression-free survival was defined as the time from date of registration to the date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free were censored at date of last contact.
Time Frame	Every 6 weeks until progression of disease up to a maximum of 3 years after registration.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment (E7389 IV)
Arm/Group Description	Patients receive E7389 IV on days 1 and 8 of an every 21-day cycle.
Measure Participants	40
Median (95% Confidence Interval) [months]	3

3. Secondary Outcome

Title	Overall Survival
Description	Overall survival was defined as the time from the date of registration to the date of death due to any cause. Patients last known to be alive are censored at date of last contact.
Time Frame	Every 3 months for first year, then every six months thereafter up to a maximum of 3 years from registration.

Outcome Measure Data

Analysis Population Description

Only eligible patients were included in the analysis.

Arm/Group Title	Treatment (E7389 IV)
Arm/Group Description	Patients receive E7389 IV on days 1 and 8 of an every 21-day cycle.
Measure Participants	40
Median (95% Confidence Interval) [months]	7

4. Secondary Outcome

Title	Participants With a Given Type of AE
Description	The NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 3.0 was utilized.
Time Frame	Every 3 weeks while on protocol therapy, up to 3 years.

Outcome Measure Data

Analysis Population Description

All eligible patients who started protocol treatment are included in analysis of toxicity

Arm/Group Title	Treatment (E7389 IV)
Arm/Group Description	Patients receive E7389 IV on days 1 and 8 of an every 21-day cycle.
Measure Participants	40
Dehydration	1 2.5%
Diarrhea	2 5%
Dry mouth/salivary gland (xerostomia)	1 2.5%
Dyspnea (shortness of breath)	2 5%
Fatigue (asthenia, lethargy, malaise)	2 5%
Glucose, serum-high (hyperglycemia)	1 2.5%
Hemoglobin	1 2.5%
Hemorrhage - Bronchopulmonary NOS	1 2.5%
Infection w/ Grade 3/4 ANC - Skin (cellulitis)	1 2.5%
Infection w unk ANC - gums (gingivitis)	1 2.5%
Leukocytes (total WBC)	5 12.5%
Lymphopenia	6 15%
Mucositis - gums (gingivitis)	1 2.5%
Neuropathy: sensory	1 2.5%
Neutrophils/granulocytes (ANC/AGC)	4 10%
Pneumonitis/pulmonary infiltrates	1 2.5%
Potassium, serum-low (hypokalemia)	1 2.5%
Sodium, serum-low (hyponatremia)	2 5%

Adverse Events

Time Frame	Patients were assessed on Day 1 and Day 8 of every 21-day cycle of treatment.
Adverse Event Reporting Description	This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
Arm/Group Title	Treatment (E7389 IV)
Arm/Group Description	Patients receive E7389 IV on days 1 and 8 of an every 21-day cycle. Includes only patients who received drug.
All Cause Mortality
	Treatment (E7389 IV)
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Treatment (E7389 IV)
	Affected / at Risk (%)	# Events
Total	5/40 (12.5%)
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)	1/40 (2.5%)
Infections and infestations
Infection (documented clinically or microbiologically) with Grade3 or 4 neutrophils-Skin(cellulitis)	1/40 (2.5%)
Investigations
Leukocytes (total WBC)	1/40 (2.5%)
Lymphopenia	2/40 (5%)
Neutrophils/granulocytes (ANC/AGC)	1/40 (2.5%)
Weight loss	1/40 (2.5%)
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory - Bronchopulmonary NOS	1/40 (2.5%)
Other (Not Including Serious) Adverse Events
	Treatment (E7389 IV)
	Affected / at Risk (%)	# Events
Total	36/40 (90%)
Blood and lymphatic system disorders
Hemoglobin	20/40 (50%)
Gastrointestinal disorders
Constipation	5/40 (12.5%)
Diarrhea	9/40 (22.5%)
Heartburn/dyspepsia	2/40 (5%)
Mucositis/stomatitis (clinical exam) - Oral cavity	4/40 (10%)
Mucositis/stomatitis (functional/symptomatic) - Oral cavity	2/40 (5%)
Nausea	14/40 (35%)
Pain - Oral cavity	2/40 (5%)
Vomiting	4/40 (10%)
General disorders
Fatigue (asthenia, lethargy, malaise)	20/40 (50%)
Fever (in the absence of neutropenia, where neutropenia is defined as ANC lt1.0 x 10e9/L)	2/40 (5%)
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Oral cavity-gums (gingivitis)	2/40 (5%)
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)	2/40 (5%)
AST, SGOT (serum glutamic oxaloacetic transaminase)	4/40 (10%)
Alkaline phosphatase	5/40 (12.5%)
Leukocytes (total WBC)	11/40 (27.5%)
Lymphopenia	9/40 (22.5%)
Neutrophils/granulocytes (ANC/AGC)	12/40 (30%)
Platelets	2/40 (5%)
Weight loss	8/40 (20%)
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)	6/40 (15%)
Anorexia	4/40 (10%)
Calcium, serum-low (hypocalcemia)	4/40 (10%)
Dehydration	3/40 (7.5%)
Glucose, serum-high (hyperglycemia)	6/40 (15%)
Potassium, serum-high (hyperkalemia)	2/40 (5%)
Potassium, serum-low (hypokalemia)	4/40 (10%)
Sodium, serum-low (hyponatremia)	4/40 (10%)
Musculoskeletal and connective tissue disorders
Pain - Muscle	2/40 (5%)
Nervous system disorders
Neuropathy: sensory	5/40 (12.5%)
Pain - Head/headache	2/40 (5%)
Respiratory, thoracic and mediastinal disorders
Cough	2/40 (5%)
Dyspnea (shortness of breath)	3/40 (7.5%)
Skin and subcutaneous tissue disorders
Hair loss/Alopecia (scalp or body)	12/40 (30%)

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.