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Trial record 28 of 533 for:    "Primary Peritoneal Carcinoma"

Bevacizumab With or Without Everolimus in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal 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: NCT00886691
Recruitment Status : Active, not recruiting
First Posted : April 23, 2009
Results First Posted : July 2, 2018
Last Update Posted : July 2, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Recurrent Fallopian Tube Carcinoma
Recurrent Ovarian Carcinoma
Recurrent Primary Peritoneal Carcinoma
Interventions Biological: Bevacizumab
Drug: Everolimus
Other: Laboratory Biomarker Analysis
Other: Placebo
Enrollment 150
Recruitment Details 150 patients were enrolled into this trial. The study opened to accrual December 2010 and closed to patient entry August 2012.
Pre-assignment Details  
Arm/Group Title Everolimus (RAD001) Plus Bevacizumab Placebo Plus Bevacizumab
Hide Arm/Group Description EVEROLIMUS (RAD001) 10mg orally daily plus Bevacizumab IV at 10 mg/kg Day 1 and Day 15 (one cycle = 4 weeks) ORAL PLACEBO daily plus Bevacizumab IV at 10 mg/kg Day 1 and Day 15 (one cycle = 4 weeks)
Period Title: Overall Study
Started 75 75
Completed 75 75
Not Completed 0 0
Arm/Group Title Everolimus (RAD001) Plus Bevacizumab Placebo Plus Bevacizumab Total
Hide Arm/Group Description EVEROLIMUS (RAD001) 10mg orally daily plus Bevacizumab IV at 10 mg/kg Day 1 and Day 15 (one cycle = 4 weeks) ORAL PLACEBO daily plus Bevacizumab IV at 10 mg/kg Day 1 and Day 15 (one cycle = 4 weeks) Total of all reporting groups
Overall Number of Baseline Participants 75 75 150
Hide Baseline Analysis Population Description
All intent to treat patients
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 75 participants 150 participants
20-29 years
1
   1.3%
0
   0.0%
1
   0.7%
30-39 years
1
   1.3%
1
   1.3%
2
   1.3%
40-49 years
9
  12.0%
8
  10.7%
17
  11.3%
50-59 years
16
  21.3%
21
  28.0%
37
  24.7%
60-69 years
33
  44.0%
28
  37.3%
61
  40.7%
70-79 years
12
  16.0%
13
  17.3%
25
  16.7%
>=80 years
3
   4.0%
4
   5.3%
7
   4.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 75 participants 150 participants
Female
75
 100.0%
75
 100.0%
150
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Progression-free Survival
Hide Description The time from randomization until disease progression, death, or date of last contact. Endpoints are progression or death. Patients who are not observed with an endpoint are censored. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) as an 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time Frame Duration of time from start of treatment to time of progression, assessed up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
All intent to treat patients
Arm/Group Title Everolimus (RAD001) Plus Bevacizumab Placebo Plus Bevacizumab
Hide Arm/Group Description:
EVEROLIMUS (RAD001) 10mg orally daily plus Bevacizumab IV at 10 mg/kg Day 1 and Day 15 (one cycle = 4 weeks)
ORAL PLACEBO daily plus Bevacizumab IV at 10 mg/kg Day 1 and Day 15 (one cycle = 4 weeks)
Overall Number of Participants Analyzed 75 75
Median (95% Confidence Interval)
Unit of Measure: months
5.9
(4.11 to 7.69)
4.5
(3.75 to 6.90)
2.Secondary Outcome
Title Incidence of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0)
Hide Description Number of participants with a grade of 3 or higher during the treatment period.
Time Frame All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All Intent to treat patients.
Arm/Group Title Everolimus (RAD001) Plus Bevacizumab Placebo Plus Bevacizumab
Hide Arm/Group Description:
EVEROLIMUS (RAD001) 10mg orally daily plus Bevacizumab IV at 10 mg/kg Day 1 and Day 15 (one cycle = 4 weeks)
ORAL PLACEBO daily plus Bevacizumab IV at 10 mg/kg Day 1 and Day 15 (one cycle = 4 weeks)
Overall Number of Participants Analyzed 75 75
Measure Type: Count of Participants
Unit of Measure: Participants
43
  57.3%
20
  26.7%
3.Secondary Outcome
Title Characterize and Compare Progression-free Survival and Overall Survival in Patients With Measurable Disease (RECIST Criteria) and Patients With Detectable (Non-measurable) Disease
Hide Description Progression-free survival and overall survival broken down by measurable disease status
Time Frame Continued until disease progression was assessed or up to 5 years in follow-up.
Hide Outcome Measure Data
Hide Analysis Population Description
All Intent to treat patients
Arm/Group Title PFS (Progression Free Survival) in Non-measurable Patients PFS (Progression Free Survival) in Measurable Patients OS (Overall Survival) in Non-measurable Patients OS (Overall Survival) in Measurable Patients
Hide Arm/Group Description:
Patients with non- measurable disease
Patients with measurable disease
Patients with non- measurable disease
Patients with measurable disease
Overall Number of Participants Analyzed 29 121 29 121
Median (95% Confidence Interval)
Unit of Measure: Months
3.94
(2.63 to 5.82)
5.91
(4.27 to 7.43)
11.10 [1] 
(7.59 to NA)
16.92
(12.16 to 18.43)
[1]
Insufficient follow-up time
4.Secondary Outcome
Title The Proportion of Patients With Measurable Disease Who Have Objective Tumor Responses by Treatment.
Hide Description Complete and Partial Tumor Response by RECIST 1.0
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
All measurable patients treated on Everolimus plus Bevicizumab and Placebo plus Bevacizumab.
Arm/Group Title Everolimus (RAD001) Plus Bevacizumab Placebo Plus Bevacizumab
Hide Arm/Group Description:
EVEROLIMUS (RAD001) 10mg orally daily plus Bevacizumab IV at 10 mg/kg Day 1 and Day 15 (one cycle = 4 weeks)
ORAL PLACEBO daily plus Bevacizumab IV at 10 mg/kg Day 1 and Day 15 (one cycle = 4 weeks)
Overall Number of Participants Analyzed 63 58
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants responding
22.2
(12.7 to 34.5)
12.1
(5.0 to 23.3)
5.Secondary Outcome
Title Percentage of Participants With at Least One Cancer Antigen 125 (CA-125) Response
Hide Description Response as evaluated by CA-125 levels.A CA 125 test measures the amount of the protein CA 125 (cancer antigen 125) in blood.CA 125 is a tumor marker recommended for clinical use in the diagnosis and management of ovarian cancer. CA-125 responses were assessed with Rustin criteria. Initial values had to be 2x ULN (upper limit of normal) within 2 weeks of starting therapy to be considered evaluable.Patient were evaluated by using best overall response while receiving study therapy.
Time Frame Prior to each cycle of treatment. Then follow-up every three months for 2 years , then 6 months for 3 years for 5 years follow up.
Hide Outcome Measure Data
Hide Analysis Population Description
CA-125 evaluable patients
Arm/Group Title Everolimus (RAD001) Plus Bevacizumab Placebo Plus Bevacizumab
Hide Arm/Group Description:
EVEROLIMUS (RAD001) 10mg orally daily plus Bevacizumab IV at 10 mg/kg Day 1 and Day 15 (one cycle = 4 weeks)
ORAL PLACEBO daily plus Bevacizumab IV at 10 mg/kg Day 1 and Day 15 (one cycle = 4 weeks)
Overall Number of Participants Analyzed 44 39
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
27.3
(15.0 to 42.8)
15.4
(5.9 to 30.5)
Time Frame Study Treatment and up to 30 days after stopping study treatment, up to 5 years.
Adverse Event Reporting Description The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
 
Arm/Group Title Everolimus (RAD001) Plus Bevacizumab Placebo Plus Bevacizumab
Hide Arm/Group Description EVEROLIMUS (RAD001) 10mg orally daily plus Bevacizumab IV at 10 mg/kg Day 1 and Day 15 (one cycle = 4 weeks) ORAL PLACEBO daily plus Bevacizumab IV at 10 mg/kg Day 1 and Day 15 (one cycle = 4 weeks)
All-Cause Mortality
Everolimus (RAD001) Plus Bevacizumab Placebo Plus Bevacizumab
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Everolimus (RAD001) Plus Bevacizumab Placebo Plus Bevacizumab
Affected / at Risk (%) Affected / at Risk (%)
Total   35/75 (46.67%)   24/75 (32.00%) 
Cardiac disorders     
Atrial Fibrillation * 1  1/75 (1.33%)  0/75 (0.00%) 
Supraventricular Tachycardia * 1  0/75 (0.00%)  1/75 (1.33%) 
Pericarditis * 1  1/75 (1.33%)  0/75 (0.00%) 
Gastrointestinal disorders     
Colonic Obstruction * 1  1/75 (1.33%)  1/75 (1.33%) 
Colonic Perforation * 1  3/75 (4.00%)  0/75 (0.00%) 
Colitis * 1  1/75 (1.33%)  0/75 (0.00%) 
Vomiting * 1  4/75 (5.33%)  0/75 (0.00%) 
Small Intestinal Obstruction * 1  2/75 (2.67%)  2/75 (2.67%) 
Abdominal Pain * 1  3/75 (4.00%)  1/75 (1.33%) 
Obstruction Gastric * 1  1/75 (1.33%)  0/75 (0.00%) 
Ileus * 1  0/75 (0.00%)  1/75 (1.33%) 
Abdominal Distension * 1  1/75 (1.33%)  0/75 (0.00%) 
Nausea * 1  2/75 (2.67%)  1/75 (1.33%) 
Ascites * 1  2/75 (2.67%)  0/75 (0.00%) 
General disorders     
Non-Cardiac Chest Pain * 1  1/75 (1.33%)  0/75 (0.00%) 
Fatigue * 1  1/75 (1.33%)  0/75 (0.00%) 
Death Nos * 1  1/75 (1.33%)  1/75 (1.33%) 
Fever * 1  1/75 (1.33%)  0/75 (0.00%) 
Infections and infestations     
Sepsis * 1  1/75 (1.33%)  0/75 (0.00%) 
Lung Infection * 1  2/75 (2.67%)  0/75 (0.00%) 
Urinary Tract Infection * 1  1/75 (1.33%)  1/75 (1.33%) 
Catheter Related Infection * 1  0/75 (0.00%)  1/75 (1.33%) 
Anorectal Infection * 1  1/75 (1.33%)  1/75 (1.33%) 
Injury, poisoning and procedural complications     
Fracture * 1  0/75 (0.00%)  1/75 (1.33%) 
Investigations     
Lymphocyte Count Decreased * 1  1/75 (1.33%)  1/75 (1.33%) 
Aspartate Aminotransferase Increased * 1  0/75 (0.00%)  1/75 (1.33%) 
Metabolism and nutrition disorders     
Hypophosphatemia * 1  0/75 (0.00%)  1/75 (1.33%) 
Hyponatremia * 1  0/75 (0.00%)  2/75 (2.67%) 
Hypoalbuminemia * 1  1/75 (1.33%)  0/75 (0.00%) 
Hyperglycemia * 1  0/75 (0.00%)  1/75 (1.33%) 
Dehydration * 1  1/75 (1.33%)  0/75 (0.00%) 
Anorexia * 1  1/75 (1.33%)  0/75 (0.00%) 
Musculoskeletal and connective tissue disorders     
Joint Range Of Motion Decreased * 1  1/75 (1.33%)  0/75 (0.00%) 
Back Pain * 1  2/75 (2.67%)  0/75 (0.00%) 
Musculoskeletal And Connective Tissue Disorder - * 1  1/75 (1.33%)  0/75 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms Benign, Malignant And Unspecified (Incl * 1  0/75 (0.00%)  1/75 (1.33%) 
Treatment Related Secondary Malignancy * 1  1/75 (1.33%)  0/75 (0.00%) 
Nervous system disorders     
Intracranial Hemorrhage * 1  0/75 (0.00%)  1/75 (1.33%) 
Encephalopathy * 1  0/75 (0.00%)  1/75 (1.33%) 
Syncope * 1  0/75 (0.00%)  1/75 (1.33%) 
Psychiatric disorders     
Insomnia * 1  2/75 (2.67%)  0/75 (0.00%) 
Depression * 1  0/75 (0.00%)  1/75 (1.33%) 
Respiratory, thoracic and mediastinal disorders     
Pneumonitis * 1  2/75 (2.67%)  0/75 (0.00%) 
Pleural Effusion * 1  0/75 (0.00%)  2/75 (2.67%) 
Dyspnea * 1  1/75 (1.33%)  0/75 (0.00%) 
Vascular disorders     
Thromboembolic Event * 1  1/75 (1.33%)  2/75 (2.67%) 
Hypertension * 1  1/75 (1.33%)  1/75 (1.33%) 
Hematoma * 1  1/75 (1.33%)  0/75 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Everolimus (RAD001) Plus Bevacizumab Placebo Plus Bevacizumab
Affected / at Risk (%) Affected / at Risk (%)
Total   73/75 (97.33%)   72/75 (96.00%) 
Blood and lymphatic system disorders     
Blood And Lymphatic System Disorders - Other * 1  1/75 (1.33%)  1/75 (1.33%) 
Anemia * 1  52/75 (69.33%)  26/75 (34.67%) 
Febrile Neutropenia * 1  1/75 (1.33%)  0/75 (0.00%) 
Cardiac disorders     
Supraventricular Tachycardia * 1  1/75 (1.33%)  0/75 (0.00%) 
Sinus Bradycardia * 1  1/75 (1.33%)  0/75 (0.00%) 
Palpitations * 1  4/75 (5.33%)  3/75 (4.00%) 
Heart Failure * 1  1/75 (1.33%)  0/75 (0.00%) 
Atrial Flutter * 1  1/75 (1.33%)  0/75 (0.00%) 
Sinus Tachycardia * 1  4/75 (5.33%)  0/75 (0.00%) 
Chest Pain - Cardiac * 1  1/75 (1.33%)  0/75 (0.00%) 
Ear and labyrinth disorders     
Ear And Labyrinth Disorders - Other * 1  1/75 (1.33%)  0/75 (0.00%) 
Vertigo * 1  0/75 (0.00%)  1/75 (1.33%) 
Tinnitus * 1  2/75 (2.67%)  0/75 (0.00%) 
Hearing Impaired * 1  2/75 (2.67%)  2/75 (2.67%) 
Ear Pain * 1  4/75 (5.33%)  0/75 (0.00%) 
External Ear Pain * 1  1/75 (1.33%)  0/75 (0.00%) 
Endocrine disorders     
Hypothyroidism * 1  0/75 (0.00%)  1/75 (1.33%) 
Hyperthyroidism * 1  0/75 (0.00%)  1/75 (1.33%) 
Endocrine Disorders - Other * 1  1/75 (1.33%)  0/75 (0.00%) 
Eye disorders     
Eye Disorders - Other * 1  1/75 (1.33%)  0/75 (0.00%) 
Watering Eyes * 1  1/75 (1.33%)  0/75 (0.00%) 
Conjunctivitis * 1  1/75 (1.33%)  1/75 (1.33%) 
Blurred Vision * 1  7/75 (9.33%)  5/75 (6.67%) 
Dry Eye * 1  0/75 (0.00%)  1/75 (1.33%) 
Floaters * 1  1/75 (1.33%)  1/75 (1.33%) 
Gastrointestinal disorders     
Dysphagia * 1  9/75 (12.00%)  1/75 (1.33%) 
Dyspepsia * 1  10/75 (13.33%)  7/75 (9.33%) 
Duodenal Obstruction * 1  0/75 (0.00%)  1/75 (1.33%) 
Dry Mouth * 1  1/75 (1.33%)  1/75 (1.33%) 
Colonic Obstruction * 1  0/75 (0.00%)  1/75 (1.33%) 
Colonic Perforation * 1  1/75 (1.33%)  0/75 (0.00%) 
Colonic Fistula * 1  1/75 (1.33%)  0/75 (0.00%) 
Colitis * 1  1/75 (1.33%)  0/75 (0.00%) 
Constipation * 1  33/75 (44.00%)  26/75 (34.67%) 
Diarrhea * 1  36/75 (48.00%)  28/75 (37.33%) 
Vomiting * 1  31/75 (41.33%)  19/75 (25.33%) 
Bloating * 1  14/75 (18.67%)  6/75 (8.00%) 
Small Intestinal Perforation * 1  1/75 (1.33%)  0/75 (0.00%) 
Stomach Pain * 1  1/75 (1.33%)  1/75 (1.33%) 
Small Intestinal Obstruction * 1  1/75 (1.33%)  1/75 (1.33%) 
Anal Hemorrhage * 1  1/75 (1.33%)  0/75 (0.00%) 
Anal Mucositis * 1  1/75 (1.33%)  0/75 (0.00%) 
Rectal Fistula * 1  1/75 (1.33%)  0/75 (0.00%) 
Abdominal Pain * 1  25/75 (33.33%)  22/75 (29.33%) 
Proctitis * 1  0/75 (0.00%)  1/75 (1.33%) 
Rectal Hemorrhage * 1  2/75 (2.67%)  1/75 (1.33%) 
Oral Dysesthesia * 1  1/75 (1.33%)  0/75 (0.00%) 
Obstruction Gastric * 1  0/75 (0.00%)  1/75 (1.33%) 
Mucositis Oral * 1  44/75 (58.67%)  14/75 (18.67%) 
Lower Gastrointestinal Hemorrhage * 1  1/75 (1.33%)  0/75 (0.00%) 
Anal Pain * 1  0/75 (0.00%)  1/75 (1.33%) 
Oral Hemorrhage * 1  1/75 (1.33%)  2/75 (2.67%) 
Ileus * 1  1/75 (1.33%)  0/75 (0.00%) 
Anal Ulcer * 1  0/75 (0.00%)  1/75 (1.33%) 
Gingival Pain * 1  2/75 (2.67%)  0/75 (0.00%) 
Oral Pain * 1  4/75 (5.33%)  2/75 (2.67%) 
Abdominal Distension * 1  11/75 (14.67%)  5/75 (6.67%) 
Nausea * 1  39/75 (52.00%)  33/75 (44.00%) 
Gastroesophageal Reflux Disease * 1  2/75 (2.67%)  3/75 (4.00%) 
Rectal Pain * 1  2/75 (2.67%)  0/75 (0.00%) 
Lip Pain * 1  0/75 (0.00%)  1/75 (1.33%) 
Esophagitis * 1  2/75 (2.67%)  0/75 (0.00%) 
Hemorrhoids * 1  7/75 (9.33%)  1/75 (1.33%) 
Ascites * 1  2/75 (2.67%)  3/75 (4.00%) 
Toothache * 1  3/75 (4.00%)  1/75 (1.33%) 
Dental Caries * 1  2/75 (2.67%)  0/75 (0.00%) 
Flatulence * 1  2/75 (2.67%)  0/75 (0.00%) 
Gastritis * 1  1/75 (1.33%)  1/75 (1.33%) 
General disorders     
Pain * 1  14/75 (18.67%)  7/75 (9.33%) 
Malaise * 1  2/75 (2.67%)  0/75 (0.00%) 
Irritability * 1  0/75 (0.00%)  2/75 (2.67%) 
Flu Like Symptoms * 1  3/75 (4.00%)  0/75 (0.00%) 
Edema Trunk * 1  2/75 (2.67%)  1/75 (1.33%) 
Non-Cardiac Chest Pain * 1  3/75 (4.00%)  2/75 (2.67%) 
Edema Limbs * 1  7/75 (9.33%)  5/75 (6.67%) 
Edema Face * 1  2/75 (2.67%)  0/75 (0.00%) 
Fatigue * 1  61/75 (81.33%)  56/75 (74.67%) 
Fever * 1  11/75 (14.67%)  6/75 (8.00%) 
Gait Disturbance * 1  0/75 (0.00%)  1/75 (1.33%) 
Chills * 1  9/75 (12.00%)  3/75 (4.00%) 
Hepatobiliary disorders     
Portal Vein Thrombosis * 1  1/75 (1.33%)  0/75 (0.00%) 
Cholecystitis * 1  1/75 (1.33%)  0/75 (0.00%) 
Immune system disorders     
Allergic Reaction * 1  2/75 (2.67%)  0/75 (0.00%) 
Infections and infestations     
Infections And Infestations - Other * 1  2/75 (2.67%)  0/75 (0.00%) 
Upper Respiratory Infection * 1  2/75 (2.67%)  3/75 (4.00%) 
Tooth Infection * 1  3/75 (4.00%)  2/75 (2.67%) 
Skin Infection * 1  6/75 (8.00%)  1/75 (1.33%) 
Sinusitis * 1  6/75 (8.00%)  3/75 (4.00%) 
Sepsis * 1  1/75 (1.33%)  0/75 (0.00%) 
Pharyngitis * 1  1/75 (1.33%)  0/75 (0.00%) 
Otitis Media * 1  1/75 (1.33%)  1/75 (1.33%) 
Otitis Externa * 1  1/75 (1.33%)  0/75 (0.00%) 
Nail Infection * 1  1/75 (1.33%)  0/75 (0.00%) 
Lung Infection * 1  1/75 (1.33%)  1/75 (1.33%) 
Laryngitis * 1  0/75 (0.00%)  1/75 (1.33%) 
Paronychia * 1  1/75 (1.33%)  0/75 (0.00%) 
Device Related Infection * 1  1/75 (1.33%)  0/75 (0.00%) 
Urinary Tract Infection * 1  11/75 (14.67%)  3/75 (4.00%) 
Lip Infection * 1  0/75 (0.00%)  1/75 (1.33%) 
Anorectal Infection * 1  1/75 (1.33%)  0/75 (0.00%) 
Injury, poisoning and procedural complications     
Wound Dehiscence * 1  2/75 (2.67%)  0/75 (0.00%) 
Vascular Access Complication * 1  1/75 (1.33%)  0/75 (0.00%) 
Fracture * 1  0/75 (0.00%)  1/75 (1.33%) 
Fall * 1  1/75 (1.33%)  1/75 (1.33%) 
Burn * 1  1/75 (1.33%)  0/75 (0.00%) 
Bruising * 1  3/75 (4.00%)  1/75 (1.33%) 
Investigations     
Weight Loss * 1  15/75 (20.00%)  9/75 (12.00%) 
Weight Gain * 1  1/75 (1.33%)  2/75 (2.67%) 
Serum Amylase Increased * 1  0/75 (0.00%)  1/75 (1.33%) 
Platelet Count Decreased * 1  39/75 (52.00%)  9/75 (12.00%) 
Lymphocyte Count Decreased * 1  7/75 (9.33%)  5/75 (6.67%) 
Lipase Increased * 1  0/75 (0.00%)  1/75 (1.33%) 
Inr Increased * 1  4/75 (5.33%)  1/75 (1.33%) 
Ggt Increased * 1  0/75 (0.00%)  1/75 (1.33%) 
Creatinine Increased * 1  11/75 (14.67%)  4/75 (5.33%) 
Cholesterol High * 1  29/75 (38.67%)  11/75 (14.67%) 
Neutrophil Count Decreased * 1  33/75 (44.00%)  7/75 (9.33%) 
Cardiac Troponin I Increased * 1  1/75 (1.33%)  0/75 (0.00%) 
Cpk Increased * 1  1/75 (1.33%)  0/75 (0.00%) 
Blood Bilirubin Increased * 1  1/75 (1.33%)  2/75 (2.67%) 
White Blood Cell Decreased * 1  34/75 (45.33%)  11/75 (14.67%) 
Aspartate Aminotransferase Increased * 1  22/75 (29.33%)  3/75 (4.00%) 
Alkaline Phosphatase Increased * 1  16/75 (21.33%)  6/75 (8.00%) 
Alanine Aminotransferase Increased * 1  15/75 (20.00%)  6/75 (8.00%) 
Activated Partial Thromboplastin Time Prolonged * 1  2/75 (2.67%)  0/75 (0.00%) 
Metabolism and nutrition disorders     
Metabolism And Nutrition Disorders - Other * 1  2/75 (2.67%)  1/75 (1.33%) 
Hypophosphatemia * 1  10/75 (13.33%)  1/75 (1.33%) 
Hyponatremia * 1  14/75 (18.67%)  10/75 (13.33%) 
Hypomagnesemia * 1  15/75 (20.00%)  9/75 (12.00%) 
Hypokalemia * 1  18/75 (24.00%)  3/75 (4.00%) 
Hypoglycemia * 1  3/75 (4.00%)  3/75 (4.00%) 
Hypocalcemia * 1  17/75 (22.67%)  6/75 (8.00%) 
Hypoalbuminemia * 1  20/75 (26.67%)  7/75 (9.33%) 
Hyperuricemia * 1  6/75 (8.00%)  4/75 (5.33%) 
Hypertriglyceridemia * 1  24/75 (32.00%)  8/75 (10.67%) 
Hypernatremia * 1  4/75 (5.33%)  1/75 (1.33%) 
Hypermagnesemia * 1  3/75 (4.00%)  2/75 (2.67%) 
Hyperkalemia * 1  3/75 (4.00%)  2/75 (2.67%) 
Hyperglycemia * 1  27/75 (36.00%)  11/75 (14.67%) 
Glucose Intolerance * 1  1/75 (1.33%)  0/75 (0.00%) 
Dehydration * 1  6/75 (8.00%)  1/75 (1.33%) 
Anorexia * 1  34/75 (45.33%)  15/75 (20.00%) 
Musculoskeletal and connective tissue disorders     
Pain In Extremity * 1  10/75 (13.33%)  5/75 (6.67%) 
Neck Pain * 1  1/75 (1.33%)  0/75 (0.00%) 
Myalgia * 1  6/75 (8.00%)  18/75 (24.00%) 
Muscle Weakness Lower Limb * 1  3/75 (4.00%)  0/75 (0.00%) 
Joint Range Of Motion Decreased * 1  0/75 (0.00%)  2/75 (2.67%) 
Joint Effusion * 1  0/75 (0.00%)  1/75 (1.33%) 
Generalized Muscle Weakness * 1  5/75 (6.67%)  3/75 (4.00%) 
Flank Pain * 1  1/75 (1.33%)  0/75 (0.00%) 
Chest Wall Pain * 1  3/75 (4.00%)  3/75 (4.00%) 
Buttock Pain * 1  1/75 (1.33%)  0/75 (0.00%) 
Bone Pain * 1  0/75 (0.00%)  1/75 (1.33%) 
Back Pain * 1  9/75 (12.00%)  16/75 (21.33%) 
Arthritis * 1  6/75 (8.00%)  3/75 (4.00%) 
Arthralgia * 1  16/75 (21.33%)  20/75 (26.67%) 
Musculoskeletal And Connective Tissue Disorder - * 1  1/75 (1.33%)  0/75 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Tumor Pain * 1  2/75 (2.67%)  0/75 (0.00%) 
Nervous system disorders     
Tremor * 1  1/75 (1.33%)  0/75 (0.00%) 
Peripheral Sensory Neuropathy * 1  25/75 (33.33%)  25/75 (33.33%) 
Peripheral Motor Neuropathy * 1  0/75 (0.00%)  2/75 (2.67%) 
Paresthesia * 1  2/75 (2.67%)  3/75 (4.00%) 
Memory Impairment * 1  1/75 (1.33%)  3/75 (4.00%) 
Headache * 1  31/75 (41.33%)  29/75 (38.67%) 
Dysphasia * 1  1/75 (1.33%)  0/75 (0.00%) 
Dysgeusia * 1  9/75 (12.00%)  0/75 (0.00%) 
Dysarthria * 1  1/75 (1.33%)  0/75 (0.00%) 
Syncope * 1  0/75 (0.00%)  1/75 (1.33%) 
Dizziness * 1  9/75 (12.00%)  8/75 (10.67%) 
Cognitive Disturbance * 1  2/75 (2.67%)  0/75 (0.00%) 
Psychiatric disorders     
Psychiatric Disorders - Other * 1  0/75 (0.00%)  1/75 (1.33%) 
Libido Decreased * 1  0/75 (0.00%)  1/75 (1.33%) 
Insomnia * 1  15/75 (20.00%)  9/75 (12.00%) 
Hallucinations * 1  1/75 (1.33%)  0/75 (0.00%) 
Depression * 1  8/75 (10.67%)  12/75 (16.00%) 
Confusion * 1  2/75 (2.67%)  0/75 (0.00%) 
Anxiety * 1  12/75 (16.00%)  8/75 (10.67%) 
Agitation * 1  0/75 (0.00%)  1/75 (1.33%) 
Renal and urinary disorders     
Renal And Urinary Disorders - Other * 1  1/75 (1.33%)  0/75 (0.00%) 
Urine Discoloration * 1  1/75 (1.33%)  0/75 (0.00%) 
Urinary Urgency * 1  3/75 (4.00%)  0/75 (0.00%) 
Urinary Retention * 1  2/75 (2.67%)  1/75 (1.33%) 
Urinary Incontinence * 1  1/75 (1.33%)  1/75 (1.33%) 
Urinary Tract Pain * 1  5/75 (6.67%)  0/75 (0.00%) 
Urinary Frequency * 1  8/75 (10.67%)  1/75 (1.33%) 
Proteinuria * 1  6/75 (8.00%)  6/75 (8.00%) 
Hemoglobinuria * 1  2/75 (2.67%)  1/75 (1.33%) 
Hematuria * 1  2/75 (2.67%)  0/75 (0.00%) 
Cystitis Noninfective * 1  1/75 (1.33%)  0/75 (0.00%) 
Chronic Kidney Disease * 1  1/75 (1.33%)  0/75 (0.00%) 
Bladder Spasm * 1  1/75 (1.33%)  0/75 (0.00%) 
Acute Kidney Injury * 1  2/75 (2.67%)  0/75 (0.00%) 
Reproductive system and breast disorders     
Vaginal Pain * 1  1/75 (1.33%)  0/75 (0.00%) 
Vaginal Hemorrhage * 1  0/75 (0.00%)  4/75 (5.33%) 
Vaginal Dryness * 1  1/75 (1.33%)  1/75 (1.33%) 
Pelvic Pain * 1  4/75 (5.33%)  0/75 (0.00%) 
Menorrhagia * 1  1/75 (1.33%)  0/75 (0.00%) 
Vaginal Discharge * 1  3/75 (4.00%)  3/75 (4.00%) 
Vaginal Inflammation * 1  1/75 (1.33%)  0/75 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory, Thoracic And Mediastinal Disorders - * 1  1/75 (1.33%)  0/75 (0.00%) 
Voice Alteration * 1  3/75 (4.00%)  3/75 (4.00%) 
Sore Throat * 1  10/75 (13.33%)  1/75 (1.33%) 
Sneezing * 1  1/75 (1.33%)  1/75 (1.33%) 
Sinus Disorder * 1  3/75 (4.00%)  1/75 (1.33%) 
Postnasal Drip * 1  5/75 (6.67%)  3/75 (4.00%) 
Pneumonitis * 1  4/75 (5.33%)  0/75 (0.00%) 
Pleural Effusion * 1  1/75 (1.33%)  2/75 (2.67%) 
Pharyngeal Hemorrhage * 1  1/75 (1.33%)  0/75 (0.00%) 
Nasal Congestion * 1  11/75 (14.67%)  9/75 (12.00%) 
Hypoxia * 1  3/75 (4.00%)  0/75 (0.00%) 
Hoarseness * 1  9/75 (12.00%)  9/75 (12.00%) 
Hiccups * 1  1/75 (1.33%)  0/75 (0.00%) 
Epistaxis * 1  19/75 (25.33%)  10/75 (13.33%) 
Dyspnea * 1  26/75 (34.67%)  16/75 (21.33%) 
Cough * 1  18/75 (24.00%)  18/75 (24.00%) 
Wheezing * 1  1/75 (1.33%)  0/75 (0.00%) 
Allergic Rhinitis * 1  7/75 (9.33%)  5/75 (6.67%) 
Skin and subcutaneous tissue disorders     
Skin And Subcutaneous Tissue Disorders - Other * 1  2/75 (2.67%)  0/75 (0.00%) 
Urticaria * 1  1/75 (1.33%)  0/75 (0.00%) 
Skin Ulceration * 1  1/75 (1.33%)  1/75 (1.33%) 
Skin Hyperpigmentation * 1  0/75 (0.00%)  1/75 (1.33%) 
Rash Acneiform * 1  7/75 (9.33%)  5/75 (6.67%) 
Purpura * 1  1/75 (1.33%)  1/75 (1.33%) 
Pruritus * 1  7/75 (9.33%)  3/75 (4.00%) 
Palmar-Plantar Erythrodysesthesia Syndrome * 1  2/75 (2.67%)  1/75 (1.33%) 
Rash Maculo-Papular * 1  17/75 (22.67%)  3/75 (4.00%) 
Skin Hypopigmentation * 1  1/75 (1.33%)  0/75 (0.00%) 
Nail Ridging * 1  1/75 (1.33%)  2/75 (2.67%) 
Nail Loss * 1  2/75 (2.67%)  2/75 (2.67%) 
Nail Discoloration * 1  5/75 (6.67%)  2/75 (2.67%) 
Hyperhidrosis * 1  1/75 (1.33%)  1/75 (1.33%) 
Dry Skin * 1  4/75 (5.33%)  3/75 (4.00%) 
Alopecia * 1  9/75 (12.00%)  10/75 (13.33%) 
Surgical and medical procedures     
Surgical And Medical Procedures - Other * 1  1/75 (1.33%)  0/75 (0.00%) 
Vascular disorders     
Thromboembolic Event * 1  2/75 (2.67%)  4/75 (5.33%) 
Lymphedema * 1  2/75 (2.67%)  3/75 (4.00%) 
Hypertension * 1  24/75 (32.00%)  31/75 (41.33%) 
Hot Flashes * 1  5/75 (6.67%)  9/75 (12.00%) 
Hematoma * 1  1/75 (1.33%)  0/75 (0.00%) 
Flushing * 1  1/75 (1.33%)  2/75 (2.67%) 
*
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 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 Michael Sill, PhD.
Organization: NRG Oncology
Phone: 716-845-1169
EMail: lgedeon@gogstats.org
Layout table for additonal information
Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00886691     History of Changes
Other Study ID Numbers: GOG-0186G
NCI-2011-01914 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000640439
GOG-0186G ( Other Identifier: NRG Oncology )
GOG-0186G ( Other Identifier: CTEP )
U10CA180868 ( U.S. NIH Grant/Contract )
U10CA027469 ( U.S. NIH Grant/Contract )
First Submitted: April 22, 2009
First Posted: April 23, 2009
Results First Submitted: April 24, 2018
Results First Posted: July 2, 2018
Last Update Posted: July 2, 2018