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

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ClinicalTrials.gov Identifier: NCT00691301

Recruitment Status : Completed

First Posted : June 5, 2008

Results First Posted : January 9, 2018

Last Update Posted : January 9, 2018

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

GOG Foundation ( Gynecologic Oncology Group )

Study Type	Interventional
Study Design	Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Cervical Cancer
Interventions	Drug: cisplatin Drug: pemetrexed disodium
Enrollment	55

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Pemetrexed and Cisplatin
Arm/Group Description	Pemtrexed plus cisplatin on day 1 e...
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
Reason Not Completed
Adverse Event	10
Death	2
Lack of Efficacy	32
Withdrawal by Subject	4
Concurrent illness	2
other reason	3
Did not initiate study treatment	1

Baseline Characteristics

Arm/Group Title		Pemetrexed and Cisplatin
Arm/Group Description		Pemtrexed plus cisplatin on day 1 e...
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 Number of Baseline Participants		54
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Customized Measure Type: Number Unit of measure: Participants	Number Analyzed	54 participants
20-29 years		3
30-39 years		10
40-49 years		23
50-59 years		15
>60 years		3
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	54 participants
	Female	54 100.0%
	Male	0 0.0%
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	54 participants
	Hispanic or Latino	13 24.1%
	Not Hispanic or Latino	41 75.9%
	Unknown or Not Reported	0 0.0%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	54 participants
	American Indian or Alaska Native	1 1.9%
	Asian	2 3.7%
	Native Hawaiian or Other Pacific Islander	0 0.0%
	Black or African American	9 16.7%
	White	29 53.7%
	More than one race	0 0.0%
	Unknown or Not Reported	13 24.1%
Region of Enrollment Measure Type: Number Unit of measure: Participants
United States	Number Analyzed	54 participants
United States		54

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 targe...
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 e...
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 Number of Participants Analyzed	54
Measure Type: Number Unit of Measure: participants
Complete Response	1
Partial Response	16

2.Primary Outcome


Title	Frequency and Severity of Observed Adverse Effects
Description	All eligible and evaluable patients
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 expe...	Number of patients who experienced ...	Number of patients who experienced ...	Number of patients who experienced ...	Number of patients who experienced ...	Number of patients who experienced ...
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
Overall Number of Participants Analyzed	54	54	54	54	54	54
Measure Type: Count of Participants Unit of Measure: Participants
Leukopenia	16 29.6%	8 14.8%	15 27.8%	12 22.2%	3 5.6%	0 0.0%
Thrombocytopenia	32 59.3%	11 20.4%	5 9.3%	3 5.6%	3 5.6%	0 0.0%
Neutropenia	20 37.0%	5 9.3%	10 18.5%	12 22.2%	7 13.0%	0 0.0%
Anemia	2 3.7%	17 31.5%	22 40.7%	6 11.1%	7 13.0%	0 0.0%
Other hematologic	49 90.7%	0 0.0%	3 5.6%	1 1.9%	1 1.9%	0 0.0%
Allergy/immunology	49 90.7%	3 5.6%	0 0.0%	1 1.9%	1 1.9%	0 0.0%
Auditory/ear	39 72.2%	0 0.0%	14 25.9%	1 1.9%	0 0.0%	0 0.0%
Cardiac	47 87.0%	5 9.3%	2 3.7%	0 0.0%	0 0.0%	0 0.0%
Coagulation	53 98.1%	0 0.0%	0 0.0%	1 1.9%	0 0.0%	0 0.0%
Constitutional	6 11.1%	12 22.2%	23 42.6%	12 22.2%	1 1.9%	0 0.0%
Dermatologic	24 44.4%	20 37.0%	9 16.7%	1 1.9%	0 0.0%	0 0.0%
Endocrine	53 98.1%	1 1.9%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Nausea	7 13.0%	19 35.2%	22 40.7%	6 11.1%	0 0.0%	0 0.0%
Vomiting	19 35.2%	11 20.4%	17 31.5%	7 13.0%	0 0.0%	0 0.0%
Gastrointestinal	4 7.4%	15 27.8%	24 44.4%	10 18.5%	1 1.9%	0 0.0%
Genitourinary/renal	43 79.6%	6 11.1%	4 7.4%	1 1.9%	0 0.0%	0 0.0%
Hemorrhage	44 81.5%	7 13.0%	0 0.0%	2 3.7%	1 1.9%	0 0.0%
Infection	37 68.5%	0 0.0%	11 20.4%	6 11.1%	0 0.0%	0 0.0%
Lymphatics	42 77.8%	5 9.3%	7 13.0%	0 0.0%	0 0.0%	0 0.0%
Metabolic	10 18.5%	19 35.2%	10 18.5%	10 18.5%	5 9.3%	0 0.0%
Musculoskeletal	50 92.6%	3 5.6%	0 0.0%	1 1.9%	0 0.0%	0 0.0%
Neurosensory	31 57.4%	15 27.8%	6 11.1%	2 3.7%	0 0.0%	0 0.0%
Other neurological	42 77.8%	8 14.8%	3 5.6%	1 1.9%	0 0.0%	0 0.0%
Ocular/visual	44 81.5%	6 11.1%	2 3.7%	2 3.7%	0 0.0%	0 0.0%
Pain	18 33.3%	11 20.4%	13 24.1%	12 22.2%	0 0.0%	0 0.0%
Pulmonary	37 68.5%	9 16.7%	6 11.1%	2 3.7%	0 0.0%	0 0.0%
Sexual/reproductive	53 98.1%	1 1.9%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Syndromes	52 96.3%	1 1.9%	1 1.9%	0 0.0%	0 0.0%	0 0.0%
Vascular	50 92.6%	0 0.0%	3 5.6%	1 1.9%	0 0.0%	0 0.0%

3.Secondary Outcome


Title	Progression-free Survival
Description	Duration of progression-free survival in months.
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 e...
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 Number of Participants Analyzed	54
Median (Inter-Quartile Range) Unit of Measure: months
	5.6 (2.6 to 9.0)

4.Secondary Outcome


Title	Duration of Overall Survival
Description	Overall survival is defined as the duration of time from study entry t...
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 e...
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 Number of Participants Analyzed	54
Median (Full Range) Unit of Measure: months
	12.3 (0.3 to 38.6)

Adverse Events

Time Frame	All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Pemetrexed and Cisplatin
Arm/Group Description	Pemtrexed plus cisplatin on day 1 e...
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 (%)
Total	--/--
Serious Adverse Events Serious Adverse Events
	Pemetrexed and Cisplatin
	Affected / at Risk (%)
Total	23/54 (42.59%)
Blood and lymphatic system disorders
Leukocytes ^* 1	1/54 (1.85%)
Hemoglobin ^* 1	1/54 (1.85%)
Cardiac disorders
Hypertension ^* 1	1/54 (1.85%)
Gastrointestinal disorders
Fistula, Gi - Colon/Cecum/Appendix ^* 1	1/54 (1.85%)
Perforation, Gi - Appendix ^* 1	1/54 (1.85%)
Perforation, Gi - Colon ^* 1	1/54 (1.85%)
Vomiting ^* 1	2/54 (3.70%)
Dehydration ^* 1	1/54 (1.85%)
Nausea ^* 1	2/54 (3.70%)
Diarrhea ^* 1	1/54 (1.85%)
General disorders
Death No Ctcae Term - Sudden Death ^* 1	1/54 (1.85%)
Pain: Chest Wall ^* 1	1/54 (1.85%)
Pain: Head/Headache ^* 1	1/54 (1.85%)
Pain: Back ^* 1	1/54 (1.85%)
Pain: Abdominal Pain Nos ^* 1	3/54 (5.56%)
Immune system disorders
Allergic Reaction/Hypersensitivity ^* 1	1/54 (1.85%)
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Skin (Cellulitis) ^* 1	1/54 (1.85%)
Febrile Neutropenia ^* 1	1/54 (1.85%)
Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos ^* 1	2/54 (3.70%)
Inf Unknown Anc: Skin (Cellulitis) ^* 1	1/54 (1.85%)
Inf W/Nml Or Gr 1 Or 2 Anc: Kidney ^* 1	2/54 (3.70%)
Metabolism and nutrition disorders
Hypokalemia ^* 1	1/54 (1.85%)
Renal and urinary disorders
Stricture, Anastomotic, Gu - Ureter ^* 1	3/54 (5.56%)
Vascular disorders
Hemorrhage, Gu - Vagina ^* 1	3/54 (5.56%)
Hemorrhage, Gi - Stomach ^* 1	1/54 (1.85%)
* Indicates events were collected by non-systematic assessment 1 Term from vocabulary, CTCAE (3.0)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Pemetrexed and Cisplatin
	Affected / at Risk (%)
Total	54/54 (100.00%)
Blood and lymphatic system disorders
Neutrophils ^* 1	34/54 (62.96%)
Platelets ^* 1	22/54 (40.74%)
Blood/Bone Marrow - Other ^* 1	4/54 (7.41%)
Leukocytes ^* 1	38/54 (70.37%)
Lymphopenia ^* 1	1/54 (1.85%)
Hemoglobin ^* 1	52/54 (96.30%)
Edema: Trunk/Genital ^* 1	2/54 (3.70%)
Edema: Limb ^* 1	15/54 (27.78%)
Edema: Head And Neck ^* 1	3/54 (5.56%)
Cardiac disorders
S/N Arrhythmia: Atrial Fibrillation ^* 1	1/54 (1.85%)
Palpitations ^* 1	4/54 (7.41%)
S/N Arrhythmia: Sinus Tachycardia ^* 1	3/54 (5.56%)
S/N Arrhythmia: Sinus Bradycardia ^* 1	1/54 (1.85%)
Hypertension ^* 1	5/54 (9.26%)
Pericardial Effusion ^* 1	1/54 (1.85%)
Ear and labyrinth disorders
Auditory/Ear - Other ^* 1	1/54 (1.85%)
Hearing (Without Monitoring Program) ^* 1	2/54 (3.70%)
Tinnitus ^* 1	14/54 (25.93%)
Hearing (Monitoring Program) ^* 1	1/54 (1.85%)
Endocrine disorders
Hot Flashes ^* 1	4/54 (7.41%)
Eye disorders
Ocular/Visual - Other ^* 1	1/54 (1.85%)
Watery Eye ^* 1	2/54 (3.70%)
Dry Eye ^* 1	1/54 (1.85%)
Flashing Lights/Floaters ^* 1	2/54 (3.70%)
Diplopia ^* 1	1/54 (1.85%)
Blurred Vision ^* 1	9/54 (16.67%)
Gastrointestinal disorders
Flatulence ^* 1	1/54 (1.85%)
Fistula, Gi - Small Bowel Nos ^* 1	1/54 (1.85%)
Hemorrhoids ^* 1	1/54 (1.85%)
Heartburn ^* 1	4/54 (7.41%)
Dental: Teeth ^* 1	1/54 (1.85%)
Dysphagia ^* 1	7/54 (12.96%)
Taste Alteration ^* 1	9/54 (16.67%)
Dry Mouth ^* 1	1/54 (1.85%)
Mucositis (Functional/Sympt) - Oral Cavity ^* 1	7/54 (12.96%)
Obstruction, Gi - Small Bowel Nos ^* 1	1/54 (1.85%)
Necrosis, Gi - Stoma ^* 1	1/54 (1.85%)
Mucositis (Functional/Sympt) - Anus ^* 1	2/54 (3.70%)
Mucositis (Clinical Exam) - Oral Cavity ^* 1	13/54 (24.07%)
Mucositis (Clinical Exam) - Esophagus ^* 1	1/54 (1.85%)
Vomiting ^* 1	35/54 (64.81%)
Anorexia ^* 1	33/54 (61.11%)
Dehydration ^* 1	3/54 (5.56%)
Constipation ^* 1	37/54 (68.52%)
Nausea ^* 1	47/54 (87.04%)
Gastrointestinal - Other ^* 1	1/54 (1.85%)
Diarrhea ^* 1	26/54 (48.15%)
General disorders
Constitutional Symptoms - Other ^* 1	3/54 (5.56%)
Sweating ^* 1	16/54 (29.63%)
Weight Gain ^* 1	2/54 (3.70%)
Fever ^* 1	16/54 (29.63%)
Weight Loss ^* 1	4/54 (7.41%)
Obesity ^* 1	1/54 (1.85%)
Rigors/Chills ^* 1	11/54 (20.37%)
Fatigue ^* 1	47/54 (87.04%)
Insomnia ^* 1	10/54 (18.52%)
Pain - Other ^* 1	11/54 (20.37%)
Pain: Urethra ^* 1	1/54 (1.85%)
Pain: Pelvis ^* 1	8/54 (14.81%)
Pain: Chest /Thorax Nos ^* 1	2/54 (3.70%)
Pain: Chest Wall ^* 1	5/54 (9.26%)
Pain: Throat/Pharynx/Larynx ^* 1	4/54 (7.41%)
Pain: Head/Headache ^* 1	25/54 (46.30%)
Pain: Neck ^* 1	4/54 (7.41%)
Pain: Extremity-Limb ^* 1	13/54 (24.07%)
Pain: Buttock ^* 1	2/54 (3.70%)
Pain: Back ^* 1	18/54 (33.33%)
Pain: Joint ^* 1	6/54 (11.11%)
Pain: Bone ^* 1	3/54 (5.56%)
Pain: Lymph Node ^* 1	2/54 (3.70%)
Pain: Kidney ^* 1	1/54 (1.85%)
Pain: Bladder ^* 1	1/54 (1.85%)
Pain: Pain Nos ^* 1	1/54 (1.85%)
Pain: Stomach ^* 1	2/54 (3.70%)
Pain: Rectum ^* 1	1/54 (1.85%)
Pain: Abdominal Pain Nos ^* 1	17/54 (31.48%)
Pain: Oral - Gums ^* 1	1/54 (1.85%)
Pain: Middle Ear ^* 1	1/54 (1.85%)
Pain: External Ear ^* 1	3/54 (5.56%)
Pain: Cardiac/ Heart ^* 1	2/54 (3.70%)
Pain: Muscle ^* 1	3/54 (5.56%)
Pain: Anus ^* 1	1/54 (1.85%)
Syndromes - Other ^* 1	1/54 (1.85%)
Cytokine Release Syndrome ^* 1	2/54 (3.70%)
Immune system disorders
Allergy/Immunology - Other ^* 1	2/54 (3.70%)
Allergic Reaction/Hypersensitivity ^* 1	3/54 (5.56%)
Rhinitis ^* 1	2/54 (3.70%)
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Lung(Pneumonia) ^* 1	1/54 (1.85%)
Inf W/Nml Or Gr 1 Or 2 Anc: Blood ^* 1	1/54 (1.85%)
Inf W/Nml Or Gr 1 Or 2 Anc: Catheter-Related ^* 1	1/54 (1.85%)
Inf W/Nml Or Gr 1 Or 2 Anc: Salivary Gland ^* 1	1/54 (1.85%)
Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos ^* 1	13/54 (24.07%)
Infection - Other ^* 1	1/54 (1.85%)
Inf Unknown Anc: Vagina ^* 1	1/54 (1.85%)
Inf W/Nml Or Gr 1 Or 2 Anc: Bronchus ^* 1	1/54 (1.85%)
Inf W/Nml Or Gr 1 Or 2 Anc: Sinus ^* 1	2/54 (3.70%)
Inf W/Nml Or Gr 1 Or 2 Anc:peritoneal Cavity ^* 1	1/54 (1.85%)
Inf Unknown Anc: Urinary Tract Nos ^* 1	3/54 (5.56%)
Inf Unknown Anc: Salivary Gland ^* 1	1/54 (1.85%)
Inf W/Nml Or Gr 1 Or 2 Anc: Kidney ^* 1	1/54 (1.85%)
Inf W/Gr 3 Or 4 Anc: Urinary Tract Nos ^* 1	1/54 (1.85%)
Metabolism and nutrition disorders
Ast ^* 1	12/54 (22.22%)
Metabolic/Laboratory - Other ^* 1	3/54 (5.56%)
Proteinuria ^* 1	3/54 (5.56%)
Creatinine ^* 1	21/54 (38.89%)
Hypoalbuminemia ^* 1	14/54 (25.93%)
Alt ^* 1	11/54 (20.37%)
Alkaline Phosphatase ^* 1	15/54 (27.78%)
Bilirubin ^* 1	2/54 (3.70%)
Hypermagnesemia ^* 1	1/54 (1.85%)
Hypophosphatemia ^* 1	3/54 (5.56%)
Hyponatremia ^* 1	20/54 (37.04%)
Hypertriglyceridemia ^* 1	1/54 (1.85%)
Bicarbonate, Serum-Low ^* 1	2/54 (3.70%)
Hypernatremia ^* 1	1/54 (1.85%)
Hypocalcemia ^* 1	12/54 (22.22%)
Hyperkalemia ^* 1	4/54 (7.41%)
Hyperglycemia ^* 1	32/54 (59.26%)
Hypokalemia ^* 1	20/54 (37.04%)
Hypoglycemia ^* 1	1/54 (1.85%)
Hypercalcemia ^* 1	1/54 (1.85%)
Hypomagnesemia ^* 1	14/54 (25.93%)
Musculoskeletal and connective tissue disorders
Musculoskeletal/St: Other ^* 1	1/54 (1.85%)
Arthritis ^* 1	3/54 (5.56%)
Muscle Weakness - Whole Body/Generalized ^* 1	4/54 (7.41%)
Muscle Weakness - Extremity-Upper ^* 1	1/54 (1.85%)
Nervous system disorders
Neurology - Other ^* 1	2/54 (3.70%)
Mood Alteration - Depression ^* 1	15/54 (27.78%)
Mood Alteration - Anxiety ^* 1	11/54 (20.37%)
Mood Alteration - Agitation ^* 1	2/54 (3.70%)
Seizure ^* 1	1/54 (1.85%)
Somnolence ^* 1	1/54 (1.85%)
Cognitive Disturbance ^* 1	1/54 (1.85%)
Confusion ^* 1	1/54 (1.85%)
Memory Impairment ^* 1	1/54 (1.85%)
Dizziness ^* 1	7/54 (12.96%)
Neuropathy-Sensory ^* 1	25/54 (46.30%)
Neuropathy-Motor ^* 1	2/54 (3.70%)
Renal and urinary disorders
Renal/Genitourinary - Other ^* 1	4/54 (7.41%)
Stricture, Anastomotic, Gu - Ureter ^* 1	1/54 (1.85%)
Cystitis ^* 1	1/54 (1.85%)
Urinary Retention ^* 1	1/54 (1.85%)
Obstruction, Gu - Ureter ^* 1	4/54 (7.41%)
Incontinence, Urinary ^* 1	3/54 (5.56%)
Fistula, Gu - Vagina ^* 1	1/54 (1.85%)
Bladder Spasm ^* 1	1/54 (1.85%)
Renal Failure ^* 1	2/54 (3.70%)
Urinary Frequency ^* 1	10/54 (18.52%)
Reproductive system and breast disorders
Vaginal Discharge ^* 1	5/54 (9.26%)
Respiratory, thoracic and mediastinal disorders
Cough ^* 1	15/54 (27.78%)
Dlco ^* 1	1/54 (1.85%)
Dyspnea ^* 1	21/54 (38.89%)
Skin and subcutaneous tissue disorders
Nail Changes ^* 1	2/54 (3.70%)
Injection Site Reaction ^* 1	2/54 (3.70%)
Hair Loss/Alopecia (Scalp Or Body) ^* 1	17/54 (31.48%)
Erythema Multiforme ^* 1	1/54 (1.85%)
Hypopigmentation ^* 1	1/54 (1.85%)
Bruising ^* 1	2/54 (3.70%)
Acne ^* 1	3/54 (5.56%)
Rash ^* 1	11/54 (20.37%)
Dry Skin ^* 1	6/54 (11.11%)
Decubitus ^* 1	1/54 (1.85%)
Pruritus ^* 1	7/54 (12.96%)
Flushing ^* 1	1/54 (1.85%)
Dermatology/Skin - Other ^* 1	4/54 (7.41%)
Hyperpigmentation ^* 1	2/54 (3.70%)
Vascular disorders
Inr ^* 1	1/54 (1.85%)
Ptt ^* 1	1/54 (1.85%)
Hemorrhage, Gu - Urinary Nos ^* 1	2/54 (3.70%)
Hemorrhage, Gu - Vagina ^* 1	9/54 (16.67%)
Hemorrhage, Gi - Rectum ^* 1	8/54 (14.81%)
Hemorrhage/Pulmonary - Nose ^* 1	1/54 (1.85%)
Hematoma ^* 1	1/54 (1.85%)
Hemorrhage, Gi - Anus ^* 1	1/54 (1.85%)
Hemorrhage, Gu - Uterus ^* 1	1/54 (1.85%)
Hemorrhage, Gi - Oral Cavity ^* 1	1/54 (1.85%)
Hemorrhage, Gu - Kidney ^* 1	1/54 (1.85%)
Hemorrhage, Gi - Stomach ^* 1	1/54 (1.85%)
Hemorrhage, Gi - Abdomen Nos ^* 1	1/54 (1.85%)
Thrombosis/Embolism (Vascular Access-Related) ^* 1	1/54 (1.85%)
Thrombosis/Thrombus/Embolism ^* 1	8/54 (14.81%)
* Indicates events were collected by non-systematic assessment 1 Term from vocabulary, CTCAE (3.0)

Limitations and 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.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Linda Gedeon for Mark Brady, PhD
Organization:	Gynecologic Oncology Group
Phone:	716-845-1169
EMail:	lgedeon@gogstats.org

Layout table for additonal information

Responsible Party:	GOG Foundation ( Gynecologic Oncology Group )
ClinicalTrials.gov Identifier:	NCT00691301
Other Study ID Numbers:	GOG-0076GG GOG-0076GG CDR0000597154 ( Other Identifier: CDR ) NCI-2009-00572 ( Other Identifier: NCI )
First Submitted:	June 4, 2008
First Posted:	June 5, 2008
Results First Submitted:	November 29, 2016
Results First Posted:	January 9, 2018
Last Update Posted:	January 9, 2018

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