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OPT-821 With or Without Vaccine Therapy in Treating Patients With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cancer in Second or Third Complete Remission

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: NCT00857545
Recruitment Status : Completed
First Posted : March 6, 2009
Results First Posted : September 6, 2017
Last Update Posted : September 13, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
GOG Foundation ( Gynecologic Oncology Group )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Stage IA Fallopian Tube Cancer
Stage IA Ovarian Cancer
Stage IB Fallopian Tube Cancer
Stage IB Ovarian Cancer
Stage IC Fallopian Tube Cancer
Stage IC Ovarian Cancer
Stage IIA Fallopian Tube Cancer
Stage IIA Ovarian Cancer
Stage IIB Fallopian Tube Cancer
Stage IIB Ovarian Cancer
Stage IIC Fallopian Tube Cancer
Stage IIC Ovarian Cancer
Stage IIIA Fallopian Tube Cancer
Stage IIIA Ovarian Cancer
Stage IIIA Primary Peritoneal Cancer
Stage IIIB Fallopian Tube Cancer
Stage IIIB Ovarian Cancer
Stage IIIB Primary Peritoneal Cancer
Stage IIIC Fallopian Tube Cancer
Stage IIIC Ovarian Cancer
Stage IIIC Primary Peritoneal Cancer
Stage IV Fallopian Tube Cancer
Stage IV Ovarian Cancer
Stage IV Primary Peritoneal Cancer
Interventions Other: Laboratory Biomarker Analysis
Biological: Polyvalent Antigen-KLH Conjugate Vaccine
Biological: Saponin-based Immunoadjuvant OBI-821
Enrollment 171
Recruitment Details The study was activated on 7/26/2010 and closed to accrual on 2/4/2013.
Pre-assignment Details  
Arm/Group Title Polyvalent Antigen-KLH+OPT-821 Vaccine Non-specific Immunity With OPT-821
Hide Arm/Group Description Polyvalent antigen-KLH + OPT-821 vaccine subcutaneously administered on weeks 1, 2, 3, 7, 11, 23, 35, 47, 59, 71 and 83 for a total of 11 vaccines until disease progression or adverse effects prohibit further treatment. 1 cycle = 1 vaccine Non-specific OPT-821 subcutaneously administered on weeks 1, 2, 3, 7, 11, 23, 35, 47, 59, 71 and 83 for a total of 11 vaccines until disease progression or adverse effects prohibit further treatment. 1 cycle = 1 vaccine
Period Title: Overall Study
Started 86 85
Completed 86 [1] 85
Not Completed 0 0
[1]
Enrolled and randomized participants.
Arm/Group Title Polyvalent Antigen-KLH+OPT-821 Vaccine Non-specific Immunity With OPT-821 Total
Hide Arm/Group Description Polyvalent antigen-KLH + OPT-821 vaccine subcutaneously administered on weeks 1, 2, 3, 7, 11, 23, 35, 47, 59, 71 and 83 for a total of 11 vaccines until disease progression or adverse effects prohibit further treatment. 1 cycle = 1 vaccine Non-specific OPT-821 subcutaneously administered on weeks 1, 2, 3, 7, 11, 23, 35, 47, 59, 71 and 83 for a total of 11 vaccines until disease progression or adverse effects prohibit further treatment. 1 cycle = 1 vaccine Total of all reporting groups
Overall Number of Baseline Participants 86 85 171
Hide Baseline Analysis Population Description
Enrolled and randomized Participants
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 86 participants 85 participants 171 participants
61.3  (8.6) 59.1  (9.1) 60.2  (8.9)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 86 participants 85 participants 171 participants
40-49
8
   9.3%
14
  16.5%
22
  12.9%
50-59
29
  33.7%
31
  36.5%
60
  35.1%
60-69
37
  43.0%
26
  30.6%
63
  36.8%
70-79
10
  11.6%
14
  16.5%
24
  14.0%
80-89
2
   2.3%
0
   0.0%
2
   1.2%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 86 participants 85 participants 171 participants
Female
86
 100.0%
85
 100.0%
171
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Recurring and/or Persistent Disease   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 86 participants 85 participants 171 participants
86
 100.0%
85
 100.0%
171
 100.0%
[1]
Measure Description: Recurrent/persistent patients
Cell Type  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 86 participants 85 participants 171 participants
Adenocarcinoma with Squam. Diff ' n
0
   0.0%
1
   1.2%
1
   0.6%
Adenocarcinoma, Unsp.
3
   3.5%
1
   1.2%
4
   2.3%
Adenosquamous
2
   2.3%
0
   0.0%
2
   1.2%
Clear Cell Carcinoma
1
   1.2%
1
   1.2%
2
   1.2%
Endometrioid Adenocarcinoma
6
   7.0%
1
   1.2%
7
   4.1%
Mixed Epithelial Carcinoma
2
   2.3%
2
   2.4%
4
   2.3%
Other Carcinoma
2
   2.3%
0
   0.0%
2
   1.2%
Serous Adenocarcinoma
69
  80.2%
76
  89.4%
145
  84.8%
Transitional Cell Carcinoma
0
   0.0%
2
   2.4%
2
   1.2%
Undifferentiated Carcinoma
1
   1.2%
1
   1.2%
2
   1.2%
1.Primary Outcome
Title Progression-free Survival (PFS)
Hide Description Progression-free survival is the period of time from the date of randomization to the date of first clinical, biochemical, or radiological evidence of progression, death due to any cause or date of last contact, whichever occurs first. Progression is defined as increasing clinical, radiological or histological evidence of disease. Patients with progressing disease based on clinical or histologic basis (ie. biopsy) must also have CT scan of the abdomen and pelvis performed.
Time Frame Every 3 month until 2 years from start of treatment, then every 6 months for 3 years; then annually if patient remains in remission.
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled and randomized participants. 95% two-sided confidence interval
Arm/Group Title Polyvalent Antigen-KLH+OPT-821 Vaccine Non-specific Immunity With OPT-821
Hide Arm/Group Description:
Polyvalent antigen-KLH + OPT-821 vaccine subcutaneously administered on weeks 1, 2, 3, 7, 11, 23, 35, 47, 59, 71 and 83 for a total of 11 vaccines until disease progression or adverse effects prohibit further treatment. 1 cycle = 1 vaccine
Non-specific OPT-821 subcutaneously administered on weeks 1, 2, 3, 7, 11, 23, 35, 47, 59, 71 and 83 for a total of 11 vaccines until disease progression or adverse effects prohibit further treatment. 1 cycle = 1 vaccine
Overall Number of Participants Analyzed 86 85
Median (95% Confidence Interval)
Unit of Measure: Months
5.9
(5.4 to 7.7)
6.5
(5.1 to 7.9)
2.Secondary Outcome
Title Incidence of Adverse Effects (Grade 3 or Higher) During Treatment Period
Hide Description Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v4.0.
Time Frame During treatment period and up to 30 days after stopping the study treatment; up to 83 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled and randomized and treated Patients. Grade 3 or worse adverse events for gastrointestinal disorders were significantly associated with treatment arm at significant level of 0.05 by two-sided Fisher's exact test. The reporting arm 2 had higher proportion of patients with reported grade 3 or worse adverse events.
Arm/Group Title Polyvalent Antigen-KLH+OPT-821 Vaccine Non-specific Immunity With OPT-821
Hide Arm/Group Description:
Polyvalent antigen-KLH + OPT-821 vaccine subcutaneously administered on weeks 1, 2, 3, 7, 11, 23, 35, 47, 59, 71 and 83 for a total of 11 vaccines until disease progression or adverse effects prohibit further treatment. 1 cycle = 1 vaccine
Non-specific OPT-821 subcutaneously administered on weeks 1, 2, 3, 7, 11, 23, 35, 47, 59, 71 and 83 for a total of 11 vaccines until disease progression or adverse effects prohibit further treatment. 1 cycle = 1 vaccine
Overall Number of Participants Analyzed 86 85
Measure Type: Number
Unit of Measure: participants
Leukopenia 0 0
Thrombocytopenia 0 0
Neutropenia 1 1
Anemia 0 1
Other Investigations 1 0
Eye disorders 0 1
Gastrointestinal Disorders 2 10
General disorders & administration site condition 1 0
Immune system disorders 0 1
Infections and infestations 1 0
Metabolism and nutrition disorders 3 1
Neoplasms benign, malignant & unspecified 2 0
Nervous System 1 1
Psychiatric disorders 1 0
Renal and urinary disorders 1 0
Vascular disorders 0 2
3.Secondary Outcome
Title Overall Survival
Hide Description Overall survival is defined as the duration of time from study entry to time of death due to any cause or the date of last contact.
Time Frame From study entry to death or last contact, up to 5 years of follow-up.
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled and randomized participants. The upper limit of the 95% confidence interval for OS median in arm 1 is not available because the data is not mature enough for estimation at the time of this report.
Arm/Group Title Polyvalent Antigen-KLH+OPT-821 Vaccine Non-specific Immunity With OPT-821
Hide Arm/Group Description:
Polyvalent antigen-KLH + OPT-821 vaccine subcutaneously administered on weeks 1, 2, 3, 7, 11, 23, 35, 47, 59, 71 and 83 for a total of 11 vaccines until disease progression or adverse effects prohibit further treatment. 1 cycle = 1 vaccine
Non-specific OPT-821 subcutaneously administered on weeks 1, 2, 3, 7, 11, 23, 35, 47, 59, 71 and 83 for a total of 11 vaccines until disease progression or adverse effects prohibit further treatment. 1 cycle = 1 vaccine
Overall Number of Participants Analyzed 86 85
Median (95% Confidence Interval)
Unit of Measure: Months
46.5 [1] 
(36.4 to NA)
46.2
(29.6 to 50.5)
[1]
As of date of submission, data is not mature enough to evaluate median confidence interval.
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 Polyvalent Antigen-KLH+OPT-821 Vaccine Non-specific Immunity With OPT-821
Hide Arm/Group Description Polyvalent antigen-KLH + OPT-821 vaccine subcutaneously administered on weeks 1, 2, 3, 7, 11, 23, 35, 47, 59, 71 and 83 for a total of 11 vaccines until disease progression or adverse effects prohibit further treatment. 1 cycle = 1 vaccine Non-specific OPT-821 subcutaneously administered on weeks 1, 2, 3, 7, 11, 23, 35, 47, 59, 71 and 83 for a total of 11 vaccines until disease progression or adverse effects prohibit further treatment. 1 cycle = 1 vaccine
All-Cause Mortality
Polyvalent Antigen-KLH+OPT-821 Vaccine Non-specific Immunity With OPT-821
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Polyvalent Antigen-KLH+OPT-821 Vaccine Non-specific Immunity With OPT-821
Affected / at Risk (%) Affected / at Risk (%)
Total   5/86 (5.81%)   14/84 (16.67%) 
Gastrointestinal disorders     
Colonic Obstruction * 1  0/86 (0.00%)  1/84 (1.19%) 
Bloating * 1  0/86 (0.00%)  1/84 (1.19%) 
Small Intestinal Obstruction * 1  0/86 (0.00%)  5/84 (5.95%) 
Abdominal Pain * 1  2/86 (2.33%)  2/84 (2.38%) 
Ileal Obstruction * 1  0/86 (0.00%)  1/84 (1.19%) 
General disorders     
Fever * 1  0/86 (0.00%)  1/84 (1.19%) 
Immune system disorders     
Autoimmune Disorder * 1  0/86 (0.00%)  1/84 (1.19%) 
Infections and infestations     
Skin Infection * 1  0/86 (0.00%)  1/84 (1.19%) 
Urinary Tract Infection * 1  1/86 (1.16%)  1/84 (1.19%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms Benign, Malignant And Unspecified (Incl cysts and polyps) * 1  1/86 (1.16%)  1/84 (1.19%) 
Myelodysplastic Syndrome * 1  1/86 (1.16%)  0/84 (0.00%) 
Psychiatric disorders     
Personality Change * 1  1/86 (1.16%)  0/84 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Polyvalent Antigen-KLH+OPT-821 Vaccine Non-specific Immunity With OPT-821
Affected / at Risk (%) Affected / at Risk (%)
Total   84/86 (97.67%)   82/84 (97.62%) 
Blood and lymphatic system disorders     
Blood And Lymphatic System Disorders - Other * 1  2/86 (2.33%)  1/84 (1.19%) 
Anemia * 1  31/86 (36.05%)  33/84 (39.29%) 
Cardiac disorders     
Palpitations * 1  2/86 (2.33%)  1/84 (1.19%) 
Ear and labyrinth disorders     
Vertigo * 1  3/86 (3.49%)  1/84 (1.19%) 
Tinnitus * 1  1/86 (1.16%)  2/84 (2.38%) 
Hearing Impaired * 1  1/86 (1.16%)  2/84 (2.38%) 
Ear Pain * 1  0/86 (0.00%)  1/84 (1.19%) 
Endocrine disorders     
Hypothyroidism * 1  3/86 (3.49%)  2/84 (2.38%) 
Hyperthyroidism * 1  0/86 (0.00%)  1/84 (1.19%) 
Eye disorders     
Eye Disorders - Other * 1  0/86 (0.00%)  1/84 (1.19%) 
Watering Eyes * 1  1/86 (1.16%)  0/84 (0.00%) 
Scleral Disorder * 1  1/86 (1.16%)  0/84 (0.00%) 
Cataract * 1  1/86 (1.16%)  1/84 (1.19%) 
Blurred Vision * 1  2/86 (2.33%)  1/84 (1.19%) 
Gastrointestinal disorders     
Dyspepsia * 1  1/86 (1.16%)  3/84 (3.57%) 
Dry Mouth * 1  1/86 (1.16%)  0/84 (0.00%) 
Constipation * 1  15/86 (17.44%)  16/84 (19.05%) 
Diarrhea * 1  6/86 (6.98%)  5/84 (5.95%) 
Vomiting * 1  5/86 (5.81%)  10/84 (11.90%) 
Bloating * 1  6/86 (6.98%)  3/84 (3.57%) 
Stomach Pain * 1  2/86 (2.33%)  1/84 (1.19%) 
Small Intestinal Obstruction * 1  1/86 (1.16%)  0/84 (0.00%) 
Abdominal Pain * 1  17/86 (19.77%)  19/84 (22.62%) 
Pancreatic Necrosis * 1  1/86 (1.16%)  0/84 (0.00%) 
Rectal Hemorrhage * 1  0/86 (0.00%)  1/84 (1.19%) 
Mucositis Oral * 1  4/86 (4.65%)  1/84 (1.19%) 
Gastrointestinal Disorders - Other * 1  1/86 (1.16%)  1/84 (1.19%) 
Gastrointestinal Pain * 1  0/86 (0.00%)  1/84 (1.19%) 
Oral Pain * 1  0/86 (0.00%)  1/84 (1.19%) 
Abdominal Distension * 1  0/86 (0.00%)  3/84 (3.57%) 
Nausea * 1  13/86 (15.12%)  16/84 (19.05%) 
Gastroparesis * 1  1/86 (1.16%)  0/84 (0.00%) 
Gastroesophageal Reflux Disease * 1  2/86 (2.33%)  1/84 (1.19%) 
Lip Pain * 1  1/86 (1.16%)  0/84 (0.00%) 
Hemorrhoids * 1  0/86 (0.00%)  3/84 (3.57%) 
Ascites * 1  0/86 (0.00%)  1/84 (1.19%) 
Toothache * 1  0/86 (0.00%)  1/84 (1.19%) 
Esophageal Pain * 1  0/86 (0.00%)  1/84 (1.19%) 
Flatulence * 1  0/86 (0.00%)  2/84 (2.38%) 
General disorders     
General Disorders And Administration Site Conditio * 1  0/86 (0.00%)  1/84 (1.19%) 
Pain * 1  9/86 (10.47%)  5/84 (5.95%) 
Malaise * 1  3/86 (3.49%)  2/84 (2.38%) 
Irritability * 1  1/86 (1.16%)  0/84 (0.00%) 
Injection Site Reaction * 1  72/86 (83.72%)  68/84 (80.95%) 
Flu Like Symptoms * 1  10/86 (11.63%)  9/84 (10.71%) 
Non-Cardiac Chest Pain * 1  0/86 (0.00%)  1/84 (1.19%) 
Edema Limbs * 1  3/86 (3.49%)  3/84 (3.57%) 
Fatigue * 1  42/86 (48.84%)  35/84 (41.67%) 
Fever * 1  17/86 (19.77%)  1/84 (1.19%) 
Chills * 1  5/86 (5.81%)  2/84 (2.38%) 
Infusion Related Reaction * 1  0/86 (0.00%)  1/84 (1.19%) 
Immune system disorders     
Allergic Reaction * 1  4/86 (4.65%)  2/84 (2.38%) 
Autoimmune Disorder * 1  1/86 (1.16%)  1/84 (1.19%) 
Immune System Disorders - Other * 1  0/86 (0.00%)  1/84 (1.19%) 
Infections and infestations     
Upper Respiratory Infection * 1  2/86 (2.33%)  1/84 (1.19%) 
Skin Infection * 1  4/86 (4.65%)  2/84 (2.38%) 
Sinusitis * 1  2/86 (2.33%)  1/84 (1.19%) 
Rhinitis Infective * 1  0/86 (0.00%)  1/84 (1.19%) 
Otitis Media * 1  0/86 (0.00%)  1/84 (1.19%) 
Papulopustular Rash * 1  1/86 (1.16%)  0/84 (0.00%) 
Mucosal Infection * 1  1/86 (1.16%)  0/84 (0.00%) 
Urinary Tract Infection * 1  2/86 (2.33%)  6/84 (7.14%) 
Enterocolitis Infectious * 1  1/86 (1.16%)  0/84 (0.00%) 
Bladder Infection * 1  0/86 (0.00%)  1/84 (1.19%) 
Injury, poisoning and procedural complications     
Injury, Poisoning And Procedural Complications - O * 1  0/86 (0.00%)  2/84 (2.38%) 
Radiation Recall Reaction (Dermatologic) * 1  1/86 (1.16%)  0/84 (0.00%) 
Fracture * 1  1/86 (1.16%)  1/84 (1.19%) 
Fall * 1  1/86 (1.16%)  1/84 (1.19%) 
Bruising * 1  1/86 (1.16%)  0/84 (0.00%) 
Investigations     
Investigations - Other * 1  3/86 (3.49%)  2/84 (2.38%) 
Weight Loss * 1  1/86 (1.16%)  1/84 (1.19%) 
Weight Gain * 1  2/86 (2.33%)  0/84 (0.00%) 
Platelet Count Decreased * 1  13/86 (15.12%)  17/84 (20.24%) 
Lymphocyte Count Increased * 1  0/86 (0.00%)  1/84 (1.19%) 
Lymphocyte Count Decreased * 1  4/86 (4.65%)  4/84 (4.76%) 
Creatinine Increased * 1  5/86 (5.81%)  7/84 (8.33%) 
Cholesterol High * 1  1/86 (1.16%)  1/84 (1.19%) 
Neutrophil Count Decreased * 1  16/86 (18.60%)  17/84 (20.24%) 
Blood Bilirubin Increased * 1  0/86 (0.00%)  1/84 (1.19%) 
White Blood Cell Decreased * 1  18/86 (20.93%)  21/84 (25.00%) 
Aspartate Aminotransferase Increased * 1  5/86 (5.81%)  6/84 (7.14%) 
Alkaline Phosphatase Increased * 1  7/86 (8.14%)  12/84 (14.29%) 
Alanine Aminotransferase Increased * 1  5/86 (5.81%)  6/84 (7.14%) 
Metabolism and nutrition disorders     
Metabolism And Nutrition Disorders - Other * 1  0/86 (0.00%)  1/84 (1.19%) 
Hyponatremia * 1  4/86 (4.65%)  3/84 (3.57%) 
Hypomagnesemia * 1  1/86 (1.16%)  1/84 (1.19%) 
Hypokalemia * 1  7/86 (8.14%)  4/84 (4.76%) 
Hypoglycemia * 1  1/86 (1.16%)  5/84 (5.95%) 
Hypocalcemia * 1  4/86 (4.65%)  2/84 (2.38%) 
Hypoalbuminemia * 1  4/86 (4.65%)  1/84 (1.19%) 
Hypertriglyceridemia * 1  1/86 (1.16%)  0/84 (0.00%) 
Hypernatremia * 1  1/86 (1.16%)  1/84 (1.19%) 
Hypermagnesemia * 1  2/86 (2.33%)  0/84 (0.00%) 
Hyperglycemia * 1  11/86 (12.79%)  17/84 (20.24%) 
Hypercalcemia * 1  4/86 (4.65%)  5/84 (5.95%) 
Dehydration * 1  2/86 (2.33%)  0/84 (0.00%) 
Anorexia * 1  6/86 (6.98%)  4/84 (4.76%) 
Musculoskeletal and connective tissue disorders     
Pain In Extremity * 1  11/86 (12.79%)  10/84 (11.90%) 
Neck Pain * 1  4/86 (4.65%)  1/84 (1.19%) 
Myositis * 1  1/86 (1.16%)  0/84 (0.00%) 
Myalgia * 1  13/86 (15.12%)  11/84 (13.10%) 
Generalized Muscle Weakness * 1  2/86 (2.33%)  1/84 (1.19%) 
Flank Pain * 1  2/86 (2.33%)  0/84 (0.00%) 
Chest Wall Pain * 1  1/86 (1.16%)  1/84 (1.19%) 
Buttock Pain * 1  2/86 (2.33%)  1/84 (1.19%) 
Bone Pain * 1  1/86 (1.16%)  0/84 (0.00%) 
Back Pain * 1  4/86 (4.65%)  5/84 (5.95%) 
Arthritis * 1  1/86 (1.16%)  2/84 (2.38%) 
Arthralgia * 1  7/86 (8.14%)  10/84 (11.90%) 
Musculoskeletal And Connective Tissue Disorder - * 1  1/86 (1.16%)  1/84 (1.19%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms Benign, Malignant And Unspecified (Incl * 1  2/86 (2.33%)  0/84 (0.00%) 
Nervous system disorders     
Nervous System Disorders - Other * 1  1/86 (1.16%)  0/84 (0.00%) 
Peripheral Sensory Neuropathy * 1  14/86 (16.28%)  19/84 (22.62%) 
Peripheral Motor Neuropathy * 1  2/86 (2.33%)  1/84 (1.19%) 
Paresthesia * 1  0/86 (0.00%)  4/84 (4.76%) 
Memory Impairment * 1  1/86 (1.16%)  2/84 (2.38%) 
Headache * 1  9/86 (10.47%)  13/84 (15.48%) 
Sinus Pain * 1  1/86 (1.16%)  0/84 (0.00%) 
Syncope * 1  1/86 (1.16%)  1/84 (1.19%) 
Dizziness * 1  8/86 (9.30%)  4/84 (4.76%) 
Cognitive Disturbance * 1  1/86 (1.16%)  1/84 (1.19%) 
Ataxia * 1  1/86 (1.16%)  0/84 (0.00%) 
Psychiatric disorders     
Suicidal Ideation * 1  1/86 (1.16%)  0/84 (0.00%) 
Insomnia * 1  5/86 (5.81%)  5/84 (5.95%) 
Depression * 1  4/86 (4.65%)  1/84 (1.19%) 
Anxiety * 1  4/86 (4.65%)  5/84 (5.95%) 
Renal and urinary disorders     
Renal And Urinary Disorders - Other * 1  1/86 (1.16%)  2/84 (2.38%) 
Urinary Urgency * 1  0/86 (0.00%)  1/84 (1.19%) 
Urinary Tract Obstruction * 1  1/86 (1.16%)  0/84 (0.00%) 
Urinary Incontinence * 1  1/86 (1.16%)  0/84 (0.00%) 
Urinary Tract Pain * 1  2/86 (2.33%)  3/84 (3.57%) 
Urinary Frequency * 1  3/86 (3.49%)  9/84 (10.71%) 
Proteinuria * 1  0/86 (0.00%)  1/84 (1.19%) 
Hematuria * 1  3/86 (3.49%)  0/84 (0.00%) 
Chronic Kidney Disease * 1  5/86 (5.81%)  4/84 (4.76%) 
Reproductive system and breast disorders     
Reproductive System And Breast Disorders - Other * 1  1/86 (1.16%)  0/84 (0.00%) 
Vaginal Hemorrhage * 1  1/86 (1.16%)  0/84 (0.00%) 
Vaginal Dryness * 1  3/86 (3.49%)  1/84 (1.19%) 
Pelvic Pain * 1  2/86 (2.33%)  1/84 (1.19%) 
Breast Pain * 1  1/86 (1.16%)  0/84 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory, Thoracic And Mediastinal Disorders - * 1  0/86 (0.00%)  1/84 (1.19%) 
Voice Alteration * 1  1/86 (1.16%)  1/84 (1.19%) 
Sore Throat * 1  2/86 (2.33%)  2/84 (2.38%) 
Sinus Disorder * 1  1/86 (1.16%)  0/84 (0.00%) 
Postnasal Drip * 1  0/86 (0.00%)  1/84 (1.19%) 
Pleural Effusion * 1  0/86 (0.00%)  1/84 (1.19%) 
Nasal Congestion * 1  3/86 (3.49%)  3/84 (3.57%) 
Hoarseness * 1  2/86 (2.33%)  0/84 (0.00%) 
Hiccups * 1  0/86 (0.00%)  1/84 (1.19%) 
Epistaxis * 1  1/86 (1.16%)  1/84 (1.19%) 
Dyspnea * 1  2/86 (2.33%)  7/84 (8.33%) 
Cough * 1  5/86 (5.81%)  6/84 (7.14%) 
Allergic Rhinitis * 1  2/86 (2.33%)  2/84 (2.38%) 
Skin and subcutaneous tissue disorders     
Skin And Subcutaneous Tissue Disorders - Other * 1  1/86 (1.16%)  0/84 (0.00%) 
Urticaria * 1  0/86 (0.00%)  1/84 (1.19%) 
Skin Induration * 1  1/86 (1.16%)  1/84 (1.19%) 
Rash Acneiform * 1  2/86 (2.33%)  3/84 (3.57%) 
Pruritus * 1  6/86 (6.98%)  1/84 (1.19%) 
Photosensitivity * 1  1/86 (1.16%)  0/84 (0.00%) 
Pain Of Skin * 1  2/86 (2.33%)  1/84 (1.19%) 
Rash Maculo-Papular * 1  7/86 (8.14%)  9/84 (10.71%) 
Nail Ridging * 1  0/86 (0.00%)  1/84 (1.19%) 
Nail Discoloration * 1  1/86 (1.16%)  0/84 (0.00%) 
Hyperhidrosis * 1  1/86 (1.16%)  0/84 (0.00%) 
Erythroderma * 1  0/86 (0.00%)  1/84 (1.19%) 
Erythema Multiforme * 1  4/86 (4.65%)  2/84 (2.38%) 
Dry Skin * 1  3/86 (3.49%)  0/84 (0.00%) 
Alopecia * 1  1/86 (1.16%)  1/84 (1.19%) 
Vascular disorders     
Lymphedema * 1  0/86 (0.00%)  1/84 (1.19%) 
Hypotension * 1  1/86 (1.16%)  1/84 (1.19%) 
Hypertension * 1  2/86 (2.33%)  3/84 (3.57%) 
Hot Flashes * 1  2/86 (2.33%)  3/84 (3.57%) 
Hematoma * 1  2/86 (2.33%)  0/84 (0.00%) 
Flushing * 1  2/86 (2.33%)  2/84 (2.38%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
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 Wei Deng PhD
Organization: NRG Oncology
Phone: 716-845-1169
EMail: lgedeon@gogstats.org
Layout table for additonal information
Responsible Party: GOG Foundation ( Gynecologic Oncology Group )
ClinicalTrials.gov Identifier: NCT00857545    
Other Study ID Numbers: GOG-0255
NCI-2009-01176 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000636384
GOG-0255 ( Other Identifier: NRG Oncology )
GOG-0255 ( Other Identifier: CTEP )
U10CA180868 ( U.S. NIH Grant/Contract )
U10CA027469 ( U.S. NIH Grant/Contract )
First Submitted: March 5, 2009
First Posted: March 6, 2009
Results First Submitted: December 20, 2016
Results First Posted: September 6, 2017
Last Update Posted: September 13, 2017