Docetaxel, Trabectedin, and G-CSF or Pegfilgrastim in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Primary Peritoneal Cavity Cancer, or Fallopian Tube Cancer

• Sponsor: Gynecologic Oncology Group (Other)
• Overall Status: Completed
• CT.gov ID: NCT00569673
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 71
• Locations: 37
• Patients Per Site: 1.9

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel and trabectedin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as G-CSF and pegfilgrastim, may help the immune system recover from the side effects of chemotherapy. Giving combination chemotherapy together with G-CSF or pegfilgrastim may kill more tumor cells.

PURPOSE: This phase II trial is studying the side effects and how well giving docetaxel and trabectedin together with G-CSF or pegfilgrastim works in treating patients with recurrent or persistent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity cancer.

Condition or Disease	Intervention/Treatment	Phase
Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer	Biological: filgrastim; Biological: pegfilgrastim; Drug: docetaxel; Drug: trabectedin	Phase 2

Detailed Description

OBJECTIVES:

Primary

• To estimate the antitumor activity of docetaxel plus trabectedin in patients with persistent or recurrent ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer primarily through the frequency of objective tumor responses.

• To determine the nature and degree of toxicity of docetaxel plus trabectedin in this cohort of patients.

Secondary

• To estimate the progression-free survival and overall survival of patients treated with docetaxel and trabectedin.

OUTLINE: Patients receive docetaxel IV over 1 hour and trabectedin IV over 3 hours on day 1. Patients also receive pegfilgrastim subcutaneously (SC) on day 1 OR filgrastim (G-CSF) IV over 15-30 minutes or SC once daily beginning on day 1 and continuing until blood counts recover. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

Study Design

• Study Type: Interventional
• Actual Enrollment: 71 participants
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Evaluation of Docetaxel (NSC #628503) Plus Trabectedin (Yondelis®), R279741, IND # 101018) With Growth Factor Support in the Third-Line Treatment of Recurrent or Persistent Ovarian, Fallopian Tube or Primary Peritoneal Cancer
• Study Start Date: Mar 1, 2008
• Actual Primary Completion Date: Jan 1, 2012

Outcome Measures

Primary Outcome Measures

1. Objective Tumor Response [every other cycle for the first 6 months; then every 3 months thereafter (up to 5 years)]

   Response is measured according to Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.0): Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial Response (PR) is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. Disease Progression is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry. Stable Disease is any condition not meeting the above criteria. Indeterminate is defined as having no repeat tumor assessments following initiation of study therapy6

2. Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 [Prior to each cycle and 30 days after the last cycle (average of 5 months)]

Secondary Outcome Measures

1. Duration of Progression-free Survival and Overall Survival [up to 5 years]

Eligibility Criteria

Criteria

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

DISEASE CHARACTERISTICS:

• Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cavity carcinoma

• Recurrent or persistent disease

• Measurable disease, defined as at least 1 lesion that can be accurately measured in at least 1 dimension (longest dimension to be recorded) ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan

• Must have at least 1 "target lesion" to be used to assess response on this protocol as defined by RECIST criteria

• Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy

• Must have had 1 prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound and the initial treatment may have included high-dose therapy, consolidation, or extended therapy administered after surgical or non-surgical assessment

• Patients are allowed, but not required to receive, 2 additional cytotoxic regimens for management of recurrent or persistent disease with no more than 1 non-platinum, non-taxane regimen

• Patients who have received only 1 prior cytotoxic regimen (platinum-based regimen for management of primary disease), must meet 1 of the following criteria:

• Platinum-free interval of < 12 months

• Progressed during platinum-based therapy

• Persistent disease after a platinum-based therapy

• Not eligible for a higher priority GOG protocol (i.e., any active GOG Phase III protocol for the same patient population)

PATIENT CHARACTERISTICS:

• GOG performance status (PS) 0-2 or after receiving 1 prior treatment regimen (GOG PS 0-1 after receiving 2 or more prior regimens)

• Platelet count ≥ 100,000/mm³

• ANC count ≥ 1,500/mm³

• Hemoglobin > 9 g/dL

• Creatinine ≤ 1.5 times upper limit normal (ULN)

• AST and ALT ≤ 2.5 times ULN

• CPK normal

• Bilirubin or direct bilirubin normal

• Alkaline phosphatase normal

• Neuropathy (sensory and motor) ≤ grade 1

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No active infection requiring antibiotics (except for uncomplicated UTI)

• No other invasive malignancy within the past 5 years, except nonmelanoma skin cancer

• No known active liver disease or hepatitis

• Willing and able to have a central venous catheter

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• Recovered from effects of recent surgery, radiotherapy, or chemotherapy

• At least 1 week since prior hormonal therapy directed at the malignant tumor

• Continuation of hormone replacement therapy allowed

• At least 3 weeks since other prior therapy, including biological and immunological therapy directed at the tumor

• Chimeric or human or humanized monoclonal antibodies must be discontinued for at least 6 weeks prior to study entry

• No investigational therapy within the past 30 days

• No prior therapy with docetaxel and/or trabectedin

• No radiation to more than 25% of marrow-bearing areas

• No prior cancer treatment that contraindicates protocol therapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Providence Saint Joseph Medical Center - Burbank	Burbank	California	United States	91505
2	Jonsson Comprehensive Cancer Center at UCLA	Los Angeles	California	United States	90095-1781
3	George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus	New Britain	Connecticut	United States	06050
4	Tunnell Cancer Center at Beebe Medical Center	Lewes	Delaware	United States	19958
5	CCOP - Christiana Care Health Services	Newark	Delaware	United States	19713
6	Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center	Savannah	Georgia	United States	31403-3089
7	Rush University Medical Center	Chicago	Illinois	United States	60612
8	Hinsdale Hematology Oncology Associates	Hinsdale	Illinois	United States	60521
9	St. Vincent Indianapolis Hospital	Indianapolis	Indiana	United States	46260
10	Union Hospital Cancer Program at Union Hospital	Elkton	Maryland	United States	21921
11	UMASS Memorial Cancer Center - University Campus	Worcester	Massachusetts	United States	01655
12	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis	Saint Louis	Missouri	United States	63110
13	St. John's Regional Health Center	Springfield	Missouri	United States	65804
14	Hulston Cancer Center at Cox Medical Center South	Springfield	Missouri	United States	65807
15	Cancer Institute of New Jersey at Cooper - Voorhees	Voorhees	New Jersey	United States	08043
16	University of New Mexico Cancer Center	Albuquerque	New Mexico	United States	87131-5636
17	Alamance Cancer Center at Alamance Regional Medical Center	Burlington	North Carolina	United States	27216
18	Blumenthal Cancer Center at Carolinas Medical Center	Charlotte	North Carolina	United States	28232-2861
19	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina	United States	27157-1096
20	Case Comprehensive Cancer Center	Cleveland	Ohio	United States	44106-5065
21	MetroHealth Cancer Care Center at MetroHealth Medical Center	Cleveland	Ohio	United States	44109
22	Cleveland Clinic Cancer Center at Fairview Hospital	Cleveland	Ohio	United States	44111
23	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio	United States	44195
24	Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center	Columbus	Ohio	United States	43210-1240
25	Riverside Methodist Hospital Cancer Care	Columbus	Ohio	United States	43214-3998
26	Mount Carmel Health - West Hospital	Columbus	Ohio	United States	43222
27	David L. Rike Cancer Center at Miami Valley Hospital	Dayton	Ohio	United States	45409
28	Hillcrest Cancer Center at Hillcrest Hospital	Mayfield Heights	Ohio	United States	44124
29	Lake/University Ireland Cancer Center	Mentor	Ohio	United States	44060
30	Oklahoma University Cancer Institute	Oklahoma City	Oklahoma	United States	73104
31	Rosenfeld Cancer Center at Abington Memorial Hospital	Abington	Pennsylvania	United States	19001
32	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104-4283
33	UPMC Cancer Center at Magee-Womens Hospital	Pittsburgh	Pennsylvania	United States	15213
34	Women and Infants Hospital of Rhode Island	Providence	Rhode Island	United States	02905
35	Huntsman Cancer Institute at University of Utah	Salt Lake City	Utah	United States	84112
36	Carilion Gynecologic Oncology Associates	Roanoke	Virginia	United States	24014
37	University of Wisconsin Paul P. Carbone Comprehensive Cancer Center	Madison	Wisconsin	United States	53792-6164

Sponsors and Collaborators

• Gynecologic Oncology Group
• National Cancer Institute (NCI)

Investigators

• Study Chair: Bradley J. Monk, MD, Chao Family Comprehensive Cancer Center
• : Kristine M. Zanotti, MD, MacDonald Physicians, Incorporated at University MacDonald Womens Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gynecologic Oncology Group
• ClinicalTrials.gov Identifier: NCT00569673
• Other Study ID Numbers: GOG-0186F; GOG-0186F; CDR0000577866
• First Posted: Dec 7, 2007
• Last Update Posted: Jul 18, 2018
• Last Verified: May 1, 2014

• Keywords provided by Gynecologic Oncology Group: recurrent ovarian epithelial cancer; fallopian tube cancer; primary peritoneal cavity cancer
• Additional relevant MeSH terms: Fallopian Tube Neoplasms; Peritoneal Neoplasms; Docetaxel; Trabectedin

Study Results

Participant Flow

Arm/Group Title	Docetaxel Plus Trabectedin
Arm/Group Description	Docetaxel 60 mg/m2 IV over 1 hour followed by trabectedin (YONDELIS"µ, R279741) formerly referred to as, ET-743) 1.1 mg/m2 over 3 hours with Filgrastim (G-CSF, NSC #614629), Pegfilgrastim (G-CSF, NSC #725961) or Sargramostim (GM-CSF, NSC #613795) every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy.
Period Title: Overall Study
STARTED	71
COMPLETED	71
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Docetaxel Plus Trabectedin
Arm/Group Description	Docetaxel 60 mg/m2 IV over 1 hour followed by trabectedin (YONDELIS"µ, R279741) formerly referred to as, ET-743) 1.1 mg/m2 over 3 hours with Filgrastim (G-CSF, NSC #614629), Pegfilgrastim (G-CSF, NSC #725961) or Sargramostim (GM-CSF, NSC #613795) every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy.
Overall Participants	71
Age, Customized (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59.3 (9.2)
Age, Customized (participants) [Number]
40-49 years	10 14.1%
50-59 years	28 39.4%
60-69 years	25 35.2%
70-79 years	7 9.9%
80-89 years	1 1.4%
Sex: Female, Male (Count of Participants)
Female	71 100%
Male	0 0%
Region of Enrollment (participants) [Number]
United States	71 100%
Cell Type (participants) [Number]
Adenocarcinoma, Unspecified	7 9.9%
Clear Cell Carcinoma	3 4.2%
Endometrioid Adenocarcinoma	6 8.5%
Mixed Epithelial Carcinoma	2 2.8%
Serous Adenocarcinoma	53 74.6%

Outcome Measures

1. Primary Outcome

Title	Objective Tumor Response
Description	Response is measured according to Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.0): Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial Response (PR) is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. Disease Progression is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry. Stable Disease is any condition not meeting the above criteria. Indeterminate is defined as having no repeat tumor assessments following initiation of study therapy6
Time Frame	every other cycle for the first 6 months; then every 3 months thereafter (up to 5 years)

Outcome Measure Data

Analysis Population Description

Total number eligible and evaluable

Arm/Group Title	Docetaxel Plus Trabectedin
Arm/Group Description	Docetaxel 60 mg/m2 IV over 1 hour followed by trabectedin (YONDELIS"µ, R279741) formerly referred to as, ET-743) 1.1 mg/m2 over 3 hours with Filgrastim (G-CSF, NSC #614629), Pegfilgrastim (G-CSF, NSC #725961) or Sargramostim (GM-CSF, NSC #613795) every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy.
Measure Participants	71
Partial response	21 29.6%
Stable disease	32 45.1%
Disease progression	17 23.9%
Indeterminate	1 1.4%

2. Primary Outcome

Title	Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Time Frame	Prior to each cycle and 30 days after the last cycle (average of 5 months)

Outcome Measure Data

Analysis Population Description

Eligible and treated patients

Arm/Group Title	Docetaxel Plus Trabectedin
Arm/Group Description	Docetaxel 60 mg/m2 IV over 1 hour followed by trabectedin (YONDELIS"µ, R279741) formerly referred to as, ET-743) 1.1 mg/m2 over 3 hours with Filgrastim (G-CSF, NSC #614629), Pegfilgrastim (G-CSF, NSC #725961) or Sargramostim (GM-CSF, NSC #613795) every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy.
Measure Participants	71
Leukopenia	21 29.6%
Thrombocytopenia	7 9.9%
Neutropenia	21 29.6%
Anemia	5 7%
Other hematologic	2 2.8%
Constitutional	8 11.3%
Nausea	6 8.5%
Vomiting	7 9.9%
Gastrointestinal	11 15.5%
Hemorrhage	1 1.4%
Infection	10 14.1%
Metabolic	10 14.1%
Musculoskeletal	3 4.2%
Other neurological	2 2.8%
Pain	6 8.5%
Pulmonary	2 2.8%

3. Secondary Outcome

Title	Duration of Progression-free Survival and Overall Survival
Time Frame	up to 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
Adverse Event Reporting Description	Activation through Mar 31, 2011, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Arm/Group Title	Docetaxel Plus Trabectedin
Arm/Group Description	Docetaxel 60 mg/m2 IV over 1 hour followed by trabectedin (YONDELIS"µ, R279741) formerly referred to as, ET-743) 1.1 mg/m2 over 3 hours with Filgrastim (G-CSF, NSC #614629), Pegfilgrastim (G-CSF, NSC #725961) or Sargramostim (GM-CSF, NSC #613795) every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy.
All Cause Mortality
	Docetaxel Plus Trabectedin
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Docetaxel Plus Trabectedin
	Affected / at Risk (%)	# Events
Total	31/71 (43.7%)
Blood and lymphatic system disorders
Neutrophils	1/71 (1.4%)
Platelets	1/71 (1.4%)
Hemoglobin	1/71 (1.4%)
Edema: Head And Neck	1/71 (1.4%)
Ear and labyrinth disorders
Tinnitus	1/71 (1.4%)
Gastrointestinal disorders
Obstruction, Gi - Ileum	2/71 (2.8%)
Necrosis, Gi - Colon/Cecum/Appendix	1/71 (1.4%)
Ileus	1/71 (1.4%)
Dysphagia	1/71 (1.4%)
Obstruction, Gi - Small Bowel Nos	1/71 (1.4%)
Vomiting	1/71 (1.4%)
Dehydration	3/71 (4.2%)
Constipation	2/71 (2.8%)
Nausea	3/71 (4.2%)
Gastrointestinal - Other	1/71 (1.4%)
Diarrhea	1/71 (1.4%)
General disorders
Fever	1/71 (1.4%)
Death No Ctcae Term - Disease Progression Nos	1/71 (1.4%)
Pain: Chest /Thorax Nos	1/71 (1.4%)
Pain: Back	1/71 (1.4%)
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Blood	1/71 (1.4%)
Inf W/Nml Or Gr 1 Or 2 Anc: Skin(Cellulitis)	1/71 (1.4%)
Inf W/Nml Or Gr 1 Or 2 Anc: Catheter-Related	1/71 (1.4%)
Inf W/Nml Or Gr 1 Or 2 Anc: Abdomen Nos	1/71 (1.4%)
Inf W/Gr 3 Or 4 Anc: Bladder (Urinary)	1/71 (1.4%)
Metabolism and nutrition disorders
Alt	1/71 (1.4%)
Nervous system disorders
Dizziness	2/71 (2.8%)
Respiratory, thoracic and mediastinal disorders
Dyspnea	2/71 (2.8%)
Vascular disorders
Hemorrhage, Gi - Rectum	1/71 (1.4%)
Hemorrhage, Gi - Stomach	1/71 (1.4%)
Hemorrhage, Gi - Abdomen Nos	1/71 (1.4%)
Thrombosis/Thrombus/Embolism	1/71 (1.4%)
Other (Not Including Serious) Adverse Events
	Docetaxel Plus Trabectedin
	Affected / at Risk (%)	# Events
Total	71/71 (100%)
Blood and lymphatic system disorders
Neutrophils	37/71 (52.1%)
Platelets	43/71 (60.6%)
Blood/Bone Marrow - Other	1/71 (1.4%)
Leukocytes	40/71 (56.3%)
Lymphopenia	4/71 (5.6%)
Hemoglobin	70/71 (98.6%)
Edema: Trunk/Genital	3/71 (4.2%)
Edema: Limb	15/71 (21.1%)
Edema: Head And Neck	1/71 (1.4%)
Cardiac disorders
S/N Arrhythmia: Atrial Fibrillation	1/71 (1.4%)
Palpitations	2/71 (2.8%)
Ventricular Arrhythmia - Tachycardia	1/71 (1.4%)
S/N Arrhythmia: Sinus Tachycardia	1/71 (1.4%)
S/N Arrhythmia: Sinus Bradycardia	1/71 (1.4%)
Hypertension	3/71 (4.2%)
Hypotension	4/71 (5.6%)
Cardipulmonary Arrest	1/71 (1.4%)
Ear and labyrinth disorders
Otitis Middle Ear	1/71 (1.4%)
Hearing (Without Monitoring Program)	1/71 (1.4%)
Tinnitus	5/71 (7%)
Endocrine disorders
Hot Flashes	6/71 (8.5%)
Eye disorders
Ocular/Visual - Other	2/71 (2.8%)
Dry Eye	2/71 (2.8%)
Flashing Lights/Floaters	3/71 (4.2%)
Blurred Vision	11/71 (15.5%)
Eyelid Dysfunction	1/71 (1.4%)
Gastrointestinal disorders
Gastritis	1/71 (1.4%)
Esophagitis	1/71 (1.4%)
Heartburn	9/71 (12.7%)
Ascites	3/71 (4.2%)
Dysphagia	2/71 (2.8%)
Distention	6/71 (8.5%)
Taste Alteration	21/71 (29.6%)
Incontinence, Anal	1/71 (1.4%)
Dry Mouth	5/71 (7%)
Mucositis (Functional/Sympt) - Oral Cavity	11/71 (15.5%)
Mucositis (Clinical Exam) - Oral Cavity	6/71 (8.5%)
Vomiting	35/71 (49.3%)
Anorexia	33/71 (46.5%)
Dehydration	9/71 (12.7%)
Constipation	32/71 (45.1%)
Nausea	52/71 (73.2%)
Diarrhea	40/71 (56.3%)
General disorders
Constitutional Symptoms - Other	1/71 (1.4%)
Sweating	3/71 (4.2%)
Weight Gain	3/71 (4.2%)
Fever	10/71 (14.1%)
Weight Loss	8/71 (11.3%)
Rigors/Chills	6/71 (8.5%)
Fatigue	61/71 (85.9%)
Insomnia	10/71 (14.1%)
Pain - Other	2/71 (2.8%)
Pain: Urethra	2/71 (2.8%)
Pain: Chest /Thorax Nos	4/71 (5.6%)
Pain: Chest Wall	5/71 (7%)
Pain: Throat/Pharynx/Larynx	3/71 (4.2%)
Pain: Head/Headache	16/71 (22.5%)
Pain: Extremity-Limb	3/71 (4.2%)
Pain: Back	11/71 (15.5%)
Pain: Joint	7/71 (9.9%)
Pain: Bone	7/71 (9.9%)
Pain: Bladder	2/71 (2.8%)
Pain: Pain Nos	2/71 (2.8%)
Pain: Rectum	3/71 (4.2%)
Pain: Abdominal Pain Nos	22/71 (31%)
Pain: Cardiac/ Heart	1/71 (1.4%)
Pain: Tumor	1/71 (1.4%)
Pain: Liver	1/71 (1.4%)
Pain: Muscle	7/71 (9.9%)
Immune system disorders
Rhinitis	2/71 (2.8%)
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Skin (Cellulitis)	1/71 (1.4%)
Inf W/Nml Or Gr 1 Or 2 Anc: Upper Airway Nos	2/71 (2.8%)
Inf W/Nml Or Gr 1 Or 2 Anc: Lung(Pneumonia)	3/71 (4.2%)
Inf W/Nml Or Gr 1 Or 2 Anc: Eye Nos	2/71 (2.8%)
Inf W/Nml Or Gr 1 Or 2 Anc: Oral Cavity-Gums	1/71 (1.4%)
Inf W/Nml Or Gr 1 Or 2 Anc: Skin(Cellulitis)	1/71 (1.4%)
Inf W/Nml Or Gr 1 Or 2 Anc: Catheter-Related	2/71 (2.8%)
Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos	8/71 (11.3%)
Inf W/Nml Or Gr 1 Or 2 Anc: Abdomen Nos	1/71 (1.4%)
Colitis, Infectious (Eg.C. Difficile)	2/71 (2.8%)
Inf W/Gr 3 Or 4 Anc: Oral Cavity-Gums	1/71 (1.4%)
Inf W/Nml Or Gr 1 Or 2 Anc: Vagina	2/71 (2.8%)
Inf W/Nml Or Gr 1 Or 2 Anc: Sinus	1/71 (1.4%)
Inf Unknown Anc: Bladder (Urinary)	2/71 (2.8%)
Inf W/Gr 3 Or 4 Anc: Pharynx	1/71 (1.4%)
Inf W/Nml Or Gr 1 Or 2 Anc: Bladder	2/71 (2.8%)
Inf W/Gr 3 Or 4 Anc: Urinary Tract Nos	3/71 (4.2%)
Metabolism and nutrition disorders
Ast	18/71 (25.4%)
Gfr	1/71 (1.4%)
Metabolic/Laboratory - Other	6/71 (8.5%)
Cholesterol,serum High	1/71 (1.4%)
Proteinuria	2/71 (2.8%)
Hemoglobinuria	1/71 (1.4%)
Creatinine	5/71 (7%)
Hypoalbuminemia	14/71 (19.7%)
Ggt	2/71 (2.8%)
Alt	23/71 (32.4%)
Alkaline Phosphatase	18/71 (25.4%)
Bilirubin	3/71 (4.2%)
Lipase	1/71 (1.4%)
Hypermagnesemia	3/71 (4.2%)
Hypophosphatemia	7/71 (9.9%)
Hyponatremia	11/71 (15.5%)
Hyperuricemia	2/71 (2.8%)
Cpk	3/71 (4.2%)
Bicarbonate, Serum-Low	2/71 (2.8%)
Hypernatremia	2/71 (2.8%)
Hypocalcemia	19/71 (26.8%)
Hyperkalemia	4/71 (5.6%)
Hyperglycemia	22/71 (31%)
Hypokalemia	18/71 (25.4%)
Hypercalcemia	1/71 (1.4%)
Hypomagnesemia	16/71 (22.5%)
Musculoskeletal and connective tissue disorders
Musculoskeletal/St: Other	1/71 (1.4%)
Muscle Weakness - Whole Body/Generalized	9/71 (12.7%)
Muscle Weakness - Extremity-Lower	7/71 (9.9%)
Nervous system disorders
Involuntary Movement	3/71 (4.2%)
Neurology - Other	2/71 (2.8%)
Mood Alteration - Depression	10/71 (14.1%)
Mood Alteration - Anxiety	5/71 (7%)
Mood Alteration - Agitation	2/71 (2.8%)
Tremor	1/71 (1.4%)
Irritability	1/71 (1.4%)
Somnolence	1/71 (1.4%)
Ataxia	2/71 (2.8%)
Confusion	1/71 (1.4%)
Memory Impairment	3/71 (4.2%)
Dizziness	11/71 (15.5%)
Neuropathy-Sensory	33/71 (46.5%)
Neuropathy-Motor	2/71 (2.8%)
Renal and urinary disorders
Renal/Genitourinary - Other	2/71 (2.8%)
Cystitis	1/71 (1.4%)
Urinary Retention	1/71 (1.4%)
Urinary Electrolyte Wasting	1/71 (1.4%)
Incontinence, Urinary	4/71 (5.6%)
Renal Failure	1/71 (1.4%)
Urinary Frequency	5/71 (7%)
Reproductive system and breast disorders
Libido	1/71 (1.4%)
Vaginal Dryness	2/71 (2.8%)
Vaginal Discharge	1/71 (1.4%)
Respiratory, thoracic and mediastinal disorders
Pulmonary: Other	2/71 (2.8%)
Nasal/Paranasal Reactions	1/71 (1.4%)
Voice Changes	2/71 (2.8%)
Hypoxia	1/71 (1.4%)
Cough	13/71 (18.3%)
Pleural Effusion	4/71 (5.6%)
Dyspnea	27/71 (38%)
Skin and subcutaneous tissue disorders
Nail Changes	6/71 (8.5%)
Injection Site Reaction	1/71 (1.4%)
Hair Loss/Alopecia (Scalp Or Body)	41/71 (57.7%)
Induration	1/71 (1.4%)
Bruising	4/71 (5.6%)
Rash	8/71 (11.3%)
Dry Skin	2/71 (2.8%)
Flushing	5/71 (7%)
Dermatology/Skin - Other	2/71 (2.8%)
Hyperpigmentation	1/71 (1.4%)
Vascular disorders
International Normalized Ratio	1/71 (1.4%)
Hemorrhage, Gu - Urinary Nos	2/71 (2.8%)
Hemorrhage, Gu - Vagina	2/71 (2.8%)
Hemorrhage, Gi - Rectum	2/71 (2.8%)
Hemorrhage/Pulmonary - Nose	4/71 (5.6%)
Hematoma	1/71 (1.4%)
Hemorrhage, Gi - Abdomen Nos	1/71 (1.4%)

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.