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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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):
Gynecologic Oncology Group

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cervical Cancer
Interventions Drug: cisplatin
Drug: pemetrexed disodium
Enrollment 55
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pemetrexed and Cisplatin
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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
Arm/Group Title Pemetrexed and Cisplatin
Hide 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
Hide 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
54
1.Primary Outcome
Title Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Individuals who initiated study treatment
Arm/Group Title Pemetrexed and Cisplatin
Hide 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
Hide 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.
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Individuals who initiated study treatment
Arm/Group Title Pemetrexed and Cisplatin
Hide 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
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated patients
Arm/Group Title Pemetrexed and Cisplatin
Hide 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)
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
Hide 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   --/-- 
Show Serious Adverse Events Hide 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)
Show Other (Not Including Serious) Adverse Events Hide 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)
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: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00691301     History of Changes
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