Pemetrexed and Cisplatin in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer

• Sponsor: Gynecologic Oncology Group (Other)
• Overall Status: Completed
• CT.gov ID: NCT00691301
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 55
• Locations: 12
• Arm: 1
• Duration (Months): 69.9
• Patients Per Site: 4.6
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

RATIONALE: Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving pemetrexed together with cisplatin may kill more tumor cells.

PURPOSE: This phase II trial is studying the side effects of giving pemetrexed together with cisplatin and to see how well it works in treating patients with advanced, persistent, or recurrent cervical cancer.

Condition or Disease	Intervention/Treatment	Phase
Cervical Cancer	Drug: cisplatin; Drug: pemetrexed disodium	Phase 2

Detailed Description

OBJECTIVES:

Primary

• To estimate the antitumor activity of pemetrexed disodium and cisplatin with objective tumor response (partial and complete response) in patients with advanced, persistent, or recurrent carcinoma of the cervix.

• To determine the nature and degree of toxicity of this regimen in these patients.

Secondary

• To determine the effects of this regimen on progression-free survival and overall survival.

OUTLINE: This is a multicenter study. Patients are stratified according to prior cisplatin therapy as a radiosensitizer (yes vs no).

Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 1-4 hours on day 1. Courses repeat every 21 days 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: 55 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Limited Access Phase II Trial of Pemetrexed (Alimta, LY231514) (NSC #698037) in Combination With Cisplatin (NSC #119875) in the Treatment of Advanced, Persistent, or Recurrent Carcinoma of the Cervix
• Study Start Date: Sep 1, 2008
• Actual Primary Completion Date: Jul 1, 2014
• Actual Study Completion Date: Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pemetrexed and cisplatin Pemtrexed plus cisplatin on day 1 every 21 days	Drug: cisplatin; Cisplatin as an IV infusion at less than 1 mg/min over less than 4 hours at a dose of; Drug: pemetrexed disodium

Outcome Measures

Primary Outcome Measures

1. Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0 [CT scan or MRI if used to follow lesion for measurable disease every other cycle until disease progression or study withdrawal; and at any other time if clinically indicated, up to 5 years.]

   RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as 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. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.

2. Frequency and Severity of Observed Adverse Effects [every 21 days during study treatment and up to 30 days after the last cycle of treatment.]

   All eligible and evaluable patients

Secondary Outcome Measures

1. Progression-free Survival [From enrollment onto the study until the onset of disease progression or death, up to 5 years]

   Duration of progression-free survival in months.

2. Duration of Overall Survival [Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually, up to 5 years.]

   Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 120 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

DISEASE CHARACTERISTICS:

• Histologically confirmed squamous or nonsquamous cell carcinoma of the cervix

• Advanced, persistent, or recurrent disease

• Disease not amenable to curative therapy

• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan

• Must have ≥ 1 target lesion to be used to assess response

• 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 ≥ 90 days following completion of radiotherapy

PATIENT CHARACTERISTICS:

• GOG performance status 0-2

• Platelet count ≥ 100,000/mm^3

• ANC ≥ 1,500/mm^3

• Bilirubin ≤ 1.5 times upper limit of normal (ULN)

• Creatinine clearance ≥ 60 mL/min

• SGOT ≤ 2.5 times ULN (≤ 5 times ULN if due to hepatic metastases)

• Alkaline phosphatase ≤ 2.5 times ULN (≤ 5 times ULN if due to hepatic metastases)

• Negative pregnancy test

• Fertile patients must use effective contraception

• Neuropathy (sensory and motor) ≤ grade 1

• Able to take folic acid, vitamin B12, and dexamethasone according to study protocol

• No history of other invasive malignancies within the past 5 years, except nonmelanoma skin cancer

• No active infection requiring antibiotics with the exception of uncomplicated UTI

• No presence of third space fluid which cannot be controlled by drainage

PRIOR CONCURRENT THERAPY:

• Recovered from effects of recent surgery, radiotherapy, or other therapy

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

• At least 4 weeks since prior radiotherapy

• More than 3 years since prior radiotherapy for localized cancer of the breast, head and neck, or skin and patient remains free of recurrent or metastatic disease

• No prior radiotherapy to any portion of the abdominal cavity or pelvis except for the treatment of cervical cancer

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

• No prior cancer treatment that contraindicates study treatment

• No prior cytotoxic drugs for advanced or recurrent carcinoma of the cervix

• Prior cisplatin as a radiosensitizer for primary treatment of disease allowed

• No nonsteroidal anti-inflammatory drugs (NSAIDs) or salicylates 2-5 days before, during, or for 2 days after receiving pemetrexed disodium

• No NSAIDS with a long half-life (e.g., naproxen, piroxicam, diflunisal, or nabumetone) 5 days before, during, and for 2 days after receiving pemetrexed disodium

• Concurrent hormone replacement therapy is permitted

• Concurrent daily low-dose acetylsalicylic acid therapy (≤ 325 mg/day) allowed

• Concurrent use of acetylsalicylic acid (up to 1.3 g/day) allowed

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California	United States	90089-9181
2	Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center	Orange	California	United States	92868
3	University of Mississippi Cancer Clinic	Jackson	Mississippi	United States	39216
4	Women's Cancer Center - La Canada	Las Vegas	Nevada	United States	89169
5	MetroHealth Cancer Care Center at MetroHealth Medical Center	Cleveland	Ohio	United States	44109
6	Oklahoma University Cancer Institute	Oklahoma City	Oklahoma	United States	73104
7	Cancer Care Associates - Saint Francis Campus	Tulsa	Oklahoma	United States	74136-1929
8	Parkland Memorial Hospital	Dallas	Texas	United States	75235
9	Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas	Dallas	Texas	United States	75390
10	Lyndon B. Johnson General Hospital	Houston	Texas	United States	77026-1967
11	M. D. Anderson Cancer Center at University of Texas	Houston	Texas	United States	77030-4009
12	Carilion Gynecologic Oncology Associates	Roanoke	Virginia	United States	24016

Sponsors and Collaborators

• Gynecologic Oncology Group
• National Cancer Institute (NCI)

Investigators

• Study Chair: David S. Miller, MD, Simmons Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gynecologic Oncology Group
• ClinicalTrials.gov Identifier: NCT00691301
• Other Study ID Numbers: GOG-0076GG; GOG-0076GG; CDR0000597154; NCI-2009-00572
• First Posted: Jun 5, 2008
• Last Update Posted: Jan 9, 2018
• Last Verified: May 1, 2015

• Keywords provided by Gynecologic Oncology Group: cervical squamous cell carcinoma; recurrent cervical cancer; stage III cervical cancer; stage IVA cervical cancer; stage IVB cervical cancer
• Additional relevant MeSH terms: Uterine Cervical Neoplasms; Pemetrexed

Study Results

Participant Flow

Arm/Group Title	Pemetrexed and Cisplatin
Arm/Group Description	Pemtrexed plus cisplatin on day 1 every 21 days cisplatin: Cisplatin as an IV infusion at less than 1 mg/min over less than 4 hours at a dose of pemetrexed disodium
Period Title: Overall Study
STARTED	55
COMPLETED	1
NOT COMPLETED	54

Baseline Characteristics

Arm/Group Title	Pemetrexed and Cisplatin
Arm/Group Description	Pemtrexed plus cisplatin on day 1 every 21 days cisplatin: Cisplatin as an IV infusion at less than 1 mg/min over less than 4 hours at a dose of pemetrexed disodium
Overall Participants	54
Age, Customized (participants) [Number]
20-29 years	3 5.6%
30-39 years	10 18.5%
40-49 years	23 42.6%
50-59 years	15 27.8%
>60 years	3 5.6%
Sex: Female, Male (Count of Participants)
Female	54 100%
Male	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	13 24.1%
Not Hispanic or Latino	41 75.9%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 1.9%
Asian	2 3.7%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	9 16.7%
White	29 53.7%
More than one race	0 0%
Unknown or Not Reported	13 24.1%
Region of Enrollment (participants) [Number]
United States	54 100%

Outcome Measures

1. Primary Outcome

Title	Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0
Description	RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as 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. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.
Time Frame	CT scan or MRI if used to follow lesion for measurable disease every other cycle until disease progression or study withdrawal; and at any other time if clinically indicated, up to 5 years.

Outcome Measure Data

Analysis Population Description

Individuals who initiated study treatment

Arm/Group Title	Pemetrexed and Cisplatin
Arm/Group Description	Pemtrexed plus cisplatin on day 1 every 21 days cisplatin: Cisplatin as an IV infusion at less than 1 mg/min over less than 4 hours at a dose of pemetrexed disodium
Measure Participants	54
Complete Response	1 1.9%
Partial Response	16 29.6%

2. Primary Outcome

Title	Frequency and Severity of Observed Adverse Effects
Description	All eligible and evaluable patients
Time Frame	every 21 days during study treatment and up to 30 days after the last cycle of treatment.

Outcome Measure Data

Analysis Population Description

All eligible and evaluable patients.

Arm/Group Title	Grade 0	Grade 1 (CTCAE v 3.0)	Grade 2 (CTCAE v 3.0)	Grade 3 (CTCAE v 3.0)	Grade 4 (CTCAE v 3.0)	Grade 5 (CTCAE v 3.0)
Arm/Group Description	Number of patients who did not experience the specified AE.	Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0	Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0	Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0	Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0	Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
Measure Participants	54	54	54	54	54	54
Leukopenia	16 29.6%	8 NaN	15 NaN	12 NaN	3 NaN	0 NaN
Thrombocytopenia	32 59.3%	11 NaN	5 NaN	3 NaN	3 NaN	0 NaN
Neutropenia	20 37%	5 NaN	10 NaN	12 NaN	7 NaN	0 NaN
Anemia	2 3.7%	17 NaN	22 NaN	6 NaN	7 NaN	0 NaN
Other hematologic	49 90.7%	0 NaN	3 NaN	1 NaN	1 NaN	0 NaN
Allergy/immunology	49 90.7%	3 NaN	0 NaN	1 NaN	1 NaN	0 NaN
Auditory/ear	39 72.2%	0 NaN	14 NaN	1 NaN	0 NaN	0 NaN
Cardiac	47 87%	5 NaN	2 NaN	0 NaN	0 NaN	0 NaN
Coagulation	53 98.1%	0 NaN	0 NaN	1 NaN	0 NaN	0 NaN
Constitutional	6 11.1%	12 NaN	23 NaN	12 NaN	1 NaN	0 NaN
Dermatologic	24 44.4%	20 NaN	9 NaN	1 NaN	0 NaN	0 NaN
Endocrine	53 98.1%	1 NaN	0 NaN	0 NaN	0 NaN	0 NaN
Nausea	7 13%	19 NaN	22 NaN	6 NaN	0 NaN	0 NaN
Vomiting	19 35.2%	11 NaN	17 NaN	7 NaN	0 NaN	0 NaN
Gastrointestinal	4 7.4%	15 NaN	24 NaN	10 NaN	1 NaN	0 NaN
Genitourinary/renal	43 79.6%	6 NaN	4 NaN	1 NaN	0 NaN	0 NaN
Hemorrhage	44 81.5%	7 NaN	0 NaN	2 NaN	1 NaN	0 NaN
Infection	37 68.5%	0 NaN	11 NaN	6 NaN	0 NaN	0 NaN
Lymphatics	42 77.8%	5 NaN	7 NaN	0 NaN	0 NaN	0 NaN
Metabolic	10 18.5%	19 NaN	10 NaN	10 NaN	5 NaN	0 NaN
Musculoskeletal	50 92.6%	3 NaN	0 NaN	1 NaN	0 NaN	0 NaN
Neurosensory	31 57.4%	15 NaN	6 NaN	2 NaN	0 NaN	0 NaN
Other neurological	42 77.8%	8 NaN	3 NaN	1 NaN	0 NaN	0 NaN
Ocular/visual	44 81.5%	6 NaN	2 NaN	2 NaN	0 NaN	0 NaN
Pain	18 33.3%	11 NaN	13 NaN	12 NaN	0 NaN	0 NaN
Pulmonary	37 68.5%	9 NaN	6 NaN	2 NaN	0 NaN	0 NaN
Sexual/reproductive	53 98.1%	1 NaN	0 NaN	0 NaN	0 NaN	0 NaN
Syndromes	52 96.3%	1 NaN	1 NaN	0 NaN	0 NaN	0 NaN
Vascular	50 92.6%	0 NaN	3 NaN	1 NaN	0 NaN	0 NaN

3. Secondary Outcome

Title	Progression-free Survival
Description	Duration of progression-free survival in months.
Time Frame	From enrollment onto the study until the onset of disease progression or death, up to 5 years

Outcome Measure Data

Analysis Population Description

Individuals who initiated study treatment

Arm/Group Title	Pemetrexed and Cisplatin
Arm/Group Description	Pemtrexed plus cisplatin on day 1 every 21 days cisplatin: Cisplatin as an IV infusion at less than 1 mg/min over less than 4 hours at a dose of pemetrexed disodium
Measure Participants	54
Median (Inter-Quartile Range) [months]	5.6

4. Secondary Outcome

Title	Duration of Overall Survival
Description	Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.
Time Frame	Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually, up to 5 years.

Outcome Measure Data

Analysis Population Description

Eligible and treated patients

Arm/Group Title	Pemetrexed and Cisplatin
Arm/Group Description	Pemtrexed plus cisplatin on day 1 every 21 days cisplatin: Cisplatin as an IV infusion at less than 1 mg/min over less than 4 hours at a dose of pemetrexed disodium
Measure Participants	54
Median (Full Range) [months]	12.3

Adverse Events

Time Frame	All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
Arm/Group Title	Pemetrexed and Cisplatin
Arm/Group Description	Pemtrexed plus cisplatin on day 1 every 21 days cisplatin: Cisplatin as an IV infusion at less than 1 mg/min over less than 4 hours at a dose of pemetrexed disodium
All Cause Mortality
	Pemetrexed and Cisplatin
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Pemetrexed and Cisplatin
	Affected / at Risk (%)	# Events
Total	23/54 (42.6%)
Blood and lymphatic system disorders
Leukocytes	1/54 (1.9%)
Hemoglobin	1/54 (1.9%)
Cardiac disorders
Hypertension	1/54 (1.9%)
Gastrointestinal disorders
Fistula, Gi - Colon/Cecum/Appendix	1/54 (1.9%)
Perforation, Gi - Appendix	1/54 (1.9%)
Perforation, Gi - Colon	1/54 (1.9%)
Vomiting	2/54 (3.7%)
Dehydration	1/54 (1.9%)
Nausea	2/54 (3.7%)
Diarrhea	1/54 (1.9%)
General disorders
Death No Ctcae Term - Sudden Death	1/54 (1.9%)
Pain: Chest Wall	1/54 (1.9%)
Pain: Head/Headache	1/54 (1.9%)
Pain: Back	1/54 (1.9%)
Pain: Abdominal Pain Nos	3/54 (5.6%)
Immune system disorders
Allergic Reaction/Hypersensitivity	1/54 (1.9%)
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Skin (Cellulitis)	1/54 (1.9%)
Febrile Neutropenia	1/54 (1.9%)
Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos	2/54 (3.7%)
Inf Unknown Anc: Skin (Cellulitis)	1/54 (1.9%)
Inf W/Nml Or Gr 1 Or 2 Anc: Kidney	2/54 (3.7%)
Metabolism and nutrition disorders
Hypokalemia	1/54 (1.9%)
Renal and urinary disorders
Stricture, Anastomotic, Gu - Ureter	3/54 (5.6%)
Vascular disorders
Hemorrhage, Gu - Vagina	3/54 (5.6%)
Hemorrhage, Gi - Stomach	1/54 (1.9%)
Other (Not Including Serious) Adverse Events
	Pemetrexed and Cisplatin
	Affected / at Risk (%)	# Events
Total	54/54 (100%)
Blood and lymphatic system disorders
Neutrophils	34/54 (63%)
Platelets	22/54 (40.7%)
Blood/Bone Marrow - Other	4/54 (7.4%)
Leukocytes	38/54 (70.4%)
Lymphopenia	1/54 (1.9%)
Hemoglobin	52/54 (96.3%)
Edema: Trunk/Genital	2/54 (3.7%)
Edema: Limb	15/54 (27.8%)
Edema: Head And Neck	3/54 (5.6%)
Cardiac disorders
S/N Arrhythmia: Atrial Fibrillation	1/54 (1.9%)
Palpitations	4/54 (7.4%)
S/N Arrhythmia: Sinus Tachycardia	3/54 (5.6%)
S/N Arrhythmia: Sinus Bradycardia	1/54 (1.9%)
Hypertension	5/54 (9.3%)
Pericardial Effusion	1/54 (1.9%)
Ear and labyrinth disorders
Auditory/Ear - Other	1/54 (1.9%)
Hearing (Without Monitoring Program)	2/54 (3.7%)
Tinnitus	14/54 (25.9%)
Hearing (Monitoring Program)	1/54 (1.9%)
Endocrine disorders
Hot Flashes	4/54 (7.4%)
Eye disorders
Ocular/Visual - Other	1/54 (1.9%)
Watery Eye	2/54 (3.7%)
Dry Eye	1/54 (1.9%)
Flashing Lights/Floaters	2/54 (3.7%)
Diplopia	1/54 (1.9%)
Blurred Vision	9/54 (16.7%)
Gastrointestinal disorders
Flatulence	1/54 (1.9%)
Fistula, Gi - Small Bowel Nos	1/54 (1.9%)
Hemorrhoids	1/54 (1.9%)
Heartburn	4/54 (7.4%)
Dental: Teeth	1/54 (1.9%)
Dysphagia	7/54 (13%)
Taste Alteration	9/54 (16.7%)
Dry Mouth	1/54 (1.9%)
Mucositis (Functional/Sympt) - Oral Cavity	7/54 (13%)
Obstruction, Gi - Small Bowel Nos	1/54 (1.9%)
Necrosis, Gi - Stoma	1/54 (1.9%)
Mucositis (Functional/Sympt) - Anus	2/54 (3.7%)
Mucositis (Clinical Exam) - Oral Cavity	13/54 (24.1%)
Mucositis (Clinical Exam) - Esophagus	1/54 (1.9%)
Vomiting	35/54 (64.8%)
Anorexia	33/54 (61.1%)
Dehydration	3/54 (5.6%)
Constipation	37/54 (68.5%)
Nausea	47/54 (87%)
Gastrointestinal - Other	1/54 (1.9%)
Diarrhea	26/54 (48.1%)
General disorders
Constitutional Symptoms - Other	3/54 (5.6%)
Sweating	16/54 (29.6%)
Weight Gain	2/54 (3.7%)
Fever	16/54 (29.6%)
Weight Loss	4/54 (7.4%)
Obesity	1/54 (1.9%)
Rigors/Chills	11/54 (20.4%)
Fatigue	47/54 (87%)
Insomnia	10/54 (18.5%)
Pain - Other	11/54 (20.4%)
Pain: Urethra	1/54 (1.9%)
Pain: Pelvis	8/54 (14.8%)
Pain: Chest /Thorax Nos	2/54 (3.7%)
Pain: Chest Wall	5/54 (9.3%)
Pain: Throat/Pharynx/Larynx	4/54 (7.4%)
Pain: Head/Headache	25/54 (46.3%)
Pain: Neck	4/54 (7.4%)
Pain: Extremity-Limb	13/54 (24.1%)
Pain: Buttock	2/54 (3.7%)
Pain: Back	18/54 (33.3%)
Pain: Joint	6/54 (11.1%)
Pain: Bone	3/54 (5.6%)
Pain: Lymph Node	2/54 (3.7%)
Pain: Kidney	1/54 (1.9%)
Pain: Bladder	1/54 (1.9%)
Pain: Pain Nos	1/54 (1.9%)
Pain: Stomach	2/54 (3.7%)
Pain: Rectum	1/54 (1.9%)
Pain: Abdominal Pain Nos	17/54 (31.5%)
Pain: Oral - Gums	1/54 (1.9%)
Pain: Middle Ear	1/54 (1.9%)
Pain: External Ear	3/54 (5.6%)
Pain: Cardiac/ Heart	2/54 (3.7%)
Pain: Muscle	3/54 (5.6%)
Pain: Anus	1/54 (1.9%)
Syndromes - Other	1/54 (1.9%)
Cytokine Release Syndrome	2/54 (3.7%)
Immune system disorders
Allergy/Immunology - Other	2/54 (3.7%)
Allergic Reaction/Hypersensitivity	3/54 (5.6%)
Rhinitis	2/54 (3.7%)
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Lung(Pneumonia)	1/54 (1.9%)
Inf W/Nml Or Gr 1 Or 2 Anc: Blood	1/54 (1.9%)
Inf W/Nml Or Gr 1 Or 2 Anc: Catheter-Related	1/54 (1.9%)
Inf W/Nml Or Gr 1 Or 2 Anc: Salivary Gland	1/54 (1.9%)
Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos	13/54 (24.1%)
Infection - Other	1/54 (1.9%)
Inf Unknown Anc: Vagina	1/54 (1.9%)
Inf W/Nml Or Gr 1 Or 2 Anc: Bronchus	1/54 (1.9%)
Inf W/Nml Or Gr 1 Or 2 Anc: Sinus	2/54 (3.7%)
Inf W/Nml Or Gr 1 Or 2 Anc:peritoneal Cavity	1/54 (1.9%)
Inf Unknown Anc: Urinary Tract Nos	3/54 (5.6%)
Inf Unknown Anc: Salivary Gland	1/54 (1.9%)
Inf W/Nml Or Gr 1 Or 2 Anc: Kidney	1/54 (1.9%)
Inf W/Gr 3 Or 4 Anc: Urinary Tract Nos	1/54 (1.9%)
Metabolism and nutrition disorders
Ast	12/54 (22.2%)
Metabolic/Laboratory - Other	3/54 (5.6%)
Proteinuria	3/54 (5.6%)
Creatinine	21/54 (38.9%)
Hypoalbuminemia	14/54 (25.9%)
Alt	11/54 (20.4%)
Alkaline Phosphatase	15/54 (27.8%)
Bilirubin	2/54 (3.7%)
Hypermagnesemia	1/54 (1.9%)
Hypophosphatemia	3/54 (5.6%)
Hyponatremia	20/54 (37%)
Hypertriglyceridemia	1/54 (1.9%)
Bicarbonate, Serum-Low	2/54 (3.7%)
Hypernatremia	1/54 (1.9%)
Hypocalcemia	12/54 (22.2%)
Hyperkalemia	4/54 (7.4%)
Hyperglycemia	32/54 (59.3%)
Hypokalemia	20/54 (37%)
Hypoglycemia	1/54 (1.9%)
Hypercalcemia	1/54 (1.9%)
Hypomagnesemia	14/54 (25.9%)
Musculoskeletal and connective tissue disorders
Musculoskeletal/St: Other	1/54 (1.9%)
Arthritis	3/54 (5.6%)
Muscle Weakness - Whole Body/Generalized	4/54 (7.4%)
Muscle Weakness - Extremity-Upper	1/54 (1.9%)
Nervous system disorders
Neurology - Other	2/54 (3.7%)
Mood Alteration - Depression	15/54 (27.8%)
Mood Alteration - Anxiety	11/54 (20.4%)
Mood Alteration - Agitation	2/54 (3.7%)
Seizure	1/54 (1.9%)
Somnolence	1/54 (1.9%)
Cognitive Disturbance	1/54 (1.9%)
Confusion	1/54 (1.9%)
Memory Impairment	1/54 (1.9%)
Dizziness	7/54 (13%)
Neuropathy-Sensory	25/54 (46.3%)
Neuropathy-Motor	2/54 (3.7%)
Renal and urinary disorders
Renal/Genitourinary - Other	4/54 (7.4%)
Stricture, Anastomotic, Gu - Ureter	1/54 (1.9%)
Cystitis	1/54 (1.9%)
Urinary Retention	1/54 (1.9%)
Obstruction, Gu - Ureter	4/54 (7.4%)
Incontinence, Urinary	3/54 (5.6%)
Fistula, Gu - Vagina	1/54 (1.9%)
Bladder Spasm	1/54 (1.9%)
Renal Failure	2/54 (3.7%)
Urinary Frequency	10/54 (18.5%)
Reproductive system and breast disorders
Vaginal Discharge	5/54 (9.3%)
Respiratory, thoracic and mediastinal disorders
Cough	15/54 (27.8%)
Dlco	1/54 (1.9%)
Dyspnea	21/54 (38.9%)
Skin and subcutaneous tissue disorders
Nail Changes	2/54 (3.7%)
Injection Site Reaction	2/54 (3.7%)
Hair Loss/Alopecia (Scalp Or Body)	17/54 (31.5%)
Erythema Multiforme	1/54 (1.9%)
Hypopigmentation	1/54 (1.9%)
Bruising	2/54 (3.7%)
Acne	3/54 (5.6%)
Rash	11/54 (20.4%)
Dry Skin	6/54 (11.1%)
Decubitus	1/54 (1.9%)
Pruritus	7/54 (13%)
Flushing	1/54 (1.9%)
Dermatology/Skin - Other	4/54 (7.4%)
Hyperpigmentation	2/54 (3.7%)
Vascular disorders
Inr	1/54 (1.9%)
Ptt	1/54 (1.9%)
Hemorrhage, Gu - Urinary Nos	2/54 (3.7%)
Hemorrhage, Gu - Vagina	9/54 (16.7%)
Hemorrhage, Gi - Rectum	8/54 (14.8%)
Hemorrhage/Pulmonary - Nose	1/54 (1.9%)
Hematoma	1/54 (1.9%)
Hemorrhage, Gi - Anus	1/54 (1.9%)
Hemorrhage, Gu - Uterus	1/54 (1.9%)
Hemorrhage, Gi - Oral Cavity	1/54 (1.9%)
Hemorrhage, Gu - Kidney	1/54 (1.9%)
Hemorrhage, Gi - Stomach	1/54 (1.9%)
Hemorrhage, Gi - Abdomen Nos	1/54 (1.9%)
Thrombosis/Embolism (Vascular Access-Related)	1/54 (1.9%)
Thrombosis/Thrombus/Embolism	8/54 (14.8%)

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.