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Trial record 1 of 1 for:    "Ovarian Sex-Cord Stromal Tumor" | "Antibodies, Monoclonal"
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Bevacizumab in Treating Patients With Recurrent Sex Cord-Stromal Tumors of the Ovary

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ClinicalTrials.gov Identifier: NCT00748657
Recruitment Status : Completed
First Posted : September 8, 2008
Results First Posted : June 10, 2015
Last Update Posted : July 23, 2019
Sponsor:
Collaborator:
NRG Oncology
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Malignant Ovarian Epithelial Tumor
Ovarian Granulosa Cell Tumor
Ovarian Gynandroblastoma
Ovarian Sertoli-Leydig Cell Tumor
Ovarian Sex Cord Tumor With Annular Tubules
Ovarian Sex Cord-Stromal Tumor
Ovarian Sex Cord-Stromal Tumor of Mixed or Unclassified Cell Types
Ovarian Steroid Cell Tumor
Interventions Biological: Bevacizumab
Other: Laboratory Biomarker Analysis
Enrollment 36
Recruitment Details The study was activated on 9/22/2008 and closed to accrual on 1/31/2011 (suspended from 1/4/2010 to 8/9/2010).
Pre-assignment Details  
Arm/Group Title Bevacizumab
Hide Arm/Group Description Bevacizumab 15 mg/kg IV every 21 days until disease progression or adverse effects prohibit further treatment
Period Title: Overall Study
Started 36
Completed 36
Not Completed 0
Arm/Group Title Bevacizumab
Hide Arm/Group Description Bevacizumab 15 mg/kg IV every 21 days until disease progression or adverse effects prohibit further treatment
Overall Number of Baseline Participants 36
Hide Baseline Analysis Population Description
Eligibile and treatmed patients
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 36 participants
20-29 0
30-39 1
40-49 8
50-59 12
60-69 11
70-79 4
80-89 0
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
Female
36
 100.0%
Male
0
   0.0%
1.Primary Outcome
Title Tumor Response
Hide Description Complete and Partial Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0
Time Frame Every other cycle for 6 months; then every 3 months for two years; then every six months for three years; and at any other time if clinically indicated based on symptoms, physical signs suggestive of progressive disease or rising serum tumor maker levels
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and Treated Patients
Arm/Group Title Bevacizumab
Hide Arm/Group Description:
Bevacizumab 15 mg/kg IV every 21 days until disease progression or adverse effects prohibit further treatment
Overall Number of Participants Analyzed 36
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of patients
16.7
(7.5 to 30.3)
2.Secondary Outcome
Title Progression-free Survival
Hide Description Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.
Time Frame Every other cycle for 6 months; then every 3 months for two years; then every six months for three years; and at any other time if clinically indicated based on symptoms, physical signs suggestive of progressive disease or rising serum tumor maker levels
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and Treated Patients
Arm/Group Title Bevacizumab
Hide Arm/Group Description:
Bevacizumab 15 mg/kg IV every 21 days until disease progression or adverse effects prohibit further treatment
Overall Number of Participants Analyzed 36
Median (95% Confidence Interval)
Unit of Measure: Months
9.3
(4.1 to 15.0)
3.Secondary Outcome
Title Overall Survival
Hide Description The observed length of life from entry into the study to death or the date of last contact.
Time Frame From study entry to death or last contact, up to 5 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated patients.
Arm/Group Title Bevacizumab
Hide Arm/Group Description:
Bevacizumab 15 mg/kg IV every 21 days until disease progression or adverse effects prohibit further treatment
Overall Number of Participants Analyzed 36
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(44.9 to NA)
[1]
NA (not available): median OS was not reached but is >65.9 months, as is the upper bound of the 95% CI.
4.Secondary Outcome
Title Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0
Hide Description Adverse Events at least possibly related to study agent.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
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 (adverse event).
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 36 36 36 36 36 36
Measure Type: Count of Participants
Unit of Measure: Participants
Leukopenia
32
  88.9%
2
   5.6%
1
   2.8%
1
   2.8%
0
   0.0%
0
   0.0%
Thrombocytopenia
28
  77.8%
8
  22.2%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Anemia
21
  58.3%
7
  19.4%
7
  19.4%
1
   2.8%
0
   0.0%
0
   0.0%
Other Hematologic
33
  91.7%
2
   5.6%
1
   2.8%
0
   0.0%
0
   0.0%
0
   0.0%
Allergy/Immunology
23
  63.9%
11
  30.6%
2
   5.6%
0
   0.0%
0
   0.0%
0
   0.0%
Auditory/Ear
29
  80.6%
0
   0.0%
6
  16.7%
1
   2.8%
0
   0.0%
0
   0.0%
Cardiac
15
  41.7%
6
  16.7%
9
  25.0%
5
  13.9%
1
   2.8%
0
   0.0%
Coagulation
35
  97.2%
0
   0.0%
0
   0.0%
1
   2.8%
0
   0.0%
0
   0.0%
Constitutional
12
  33.3%
10
  27.8%
13
  36.1%
1
   2.8%
0
   0.0%
0
   0.0%
Dermatologic
17
  47.2%
14
  38.9%
4
  11.1%
1
   2.8%
0
   0.0%
0
   0.0%
Endocrine
33
  91.7%
2
   5.6%
1
   2.8%
0
   0.0%
0
   0.0%
0
   0.0%
Gastrointestinal
6
  16.7%
10
  27.8%
15
  41.7%
5
  13.9%
0
   0.0%
0
   0.0%
Genitourinary/Renal
29
  80.6%
5
  13.9%
1
   2.8%
1
   2.8%
0
   0.0%
0
   0.0%
Hemorrhage
17
  47.2%
18
  50.0%
0
   0.0%
1
   2.8%
0
   0.0%
0
   0.0%
Infection
23
  63.9%
0
   0.0%
11
  30.6%
2
   5.6%
0
   0.0%
0
   0.0%
Lymphatics
31
  86.1%
4
  11.1%
1
   2.8%
0
   0.0%
0
   0.0%
0
   0.0%
Metabolic
13
  36.1%
10
  27.8%
8
  22.2%
3
   8.3%
2
   5.6%
0
   0.0%
Musculoskeletal
30
  83.3%
5
  13.9%
1
   2.8%
0
   0.0%
0
   0.0%
0
   0.0%
Neurosensory
21
  58.3%
13
  36.1%
1
   2.8%
1
   2.8%
0
   0.0%
0
   0.0%
Other Neurological
22
  61.1%
12
  33.3%
1
   2.8%
1
   2.8%
0
   0.0%
0
   0.0%
Ocular/Visual
30
  83.3%
6
  16.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Pain
1
   2.8%
11
  30.6%
16
  44.4%
8
  22.2%
0
   0.0%
0
   0.0%
Pulmonary
12
  33.3%
20
  55.6%
1
   2.8%
3
   8.3%
0
   0.0%
0
   0.0%
Sexual/Reproductive
32
  88.9%
4
  11.1%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Syndromes
35
  97.2%
1
   2.8%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Vascular
35
  97.2%
0
   0.0%
1
   2.8%
0
   0.0%
0
   0.0%
0
   0.0%
Death, Not CTC coded
35
  97.2%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.8%
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
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bevacizumab
Hide Arm/Group Description Bevacizumab 15 mg/kg IV every 21 days until disease progression or adverse effects prohibit further treatment
All-Cause Mortality
Bevacizumab
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Bevacizumab
Affected / at Risk (%)
Total   13/36 (36.11%) 
Cardiac disorders   
S/N Arrhythmia: Sinus Bradycardia * 1  1/36 (2.78%) 
Hypertension * 1  2/36 (5.56%) 
Ear and labyrinth disorders   
Tinnitus * 1  1/36 (2.78%) 
Gastrointestinal disorders   
Ulcer,gi - Stomach * 1  1/36 (2.78%) 
Taste Alteration * 1  1/36 (2.78%) 
Obstruction, Gi - Small Bowel Nos * 1  3/36 (8.33%) 
Constipation * 1  2/36 (5.56%) 
General disorders   
Pain: Abdominal Pain Nos * 1  1/36 (2.78%) 
Pain: Tumor * 1  1/36 (2.78%) 
Infections and infestations   
Inf W/Nml Or Gr 1 Or 2 Anc: Wound * 1  1/36 (2.78%) 
Metabolism and nutrition disorders   
Hyperuricemia * 1  1/36 (2.78%) 
Hyperglycemia * 1  2/36 (5.56%) 
Nervous system disorders   
Syncope * 1  1/36 (2.78%) 
Renal and urinary disorders   
Renal/Genitourinary - Other * 1  1/36 (2.78%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea * 1  1/36 (2.78%) 
*
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%
Bevacizumab
Affected / at Risk (%)
Total   36/36 (100.00%) 
Blood and lymphatic system disorders   
Platelets * 1  8/36 (22.22%) 
Blood/Bone Marrow - Other * 1  1/36 (2.78%) 
Leukocytes * 1  4/36 (11.11%) 
Lymphopenia * 1  2/36 (5.56%) 
Hemoglobin * 1  15/36 (41.67%) 
Edema: Limb * 1  5/36 (13.89%) 
Cardiac disorders   
Palpitations * 1  4/36 (11.11%) 
Ventricular Arrhythmia - Tachycardia * 1  1/36 (2.78%) 
S/N Arrhythmia: Sinus Tachycardia * 1  1/36 (2.78%) 
S/N Arrhythmia: Sinus Bradycardia * 1  1/36 (2.78%) 
Hypertension * 1  16/36 (44.44%) 
Pericardial Effusion * 1  1/36 (2.78%) 
Ear and labyrinth disorders   
Hearing (Without Monitoring Program) * 1  3/36 (8.33%) 
Tinnitus * 1  6/36 (16.67%) 
Endocrine disorders   
Hot Flashes * 1  3/36 (8.33%) 
Eye disorders   
Watery Eye * 1  1/36 (2.78%) 
Dry Eye * 1  1/36 (2.78%) 
Photophobia * 1  1/36 (2.78%) 
Flashing Lights/Floaters * 1  1/36 (2.78%) 
Blurred Vision * 1  4/36 (11.11%) 
Gastrointestinal disorders   
Flatulence * 1  3/36 (8.33%) 
Heartburn * 1  3/36 (8.33%) 
Ulcer,gi - Stomach * 1  1/36 (2.78%) 
Dysphagia * 1  1/36 (2.78%) 
Distention * 1  3/36 (8.33%) 
Taste Alteration * 1  3/36 (8.33%) 
Dry Mouth * 1  1/36 (2.78%) 
Mucositis (Functional/Sympt) - Oral Cavity * 1  4/36 (11.11%) 
Obstruction, Gi - Small Bowel Nos * 1  1/36 (2.78%) 
Mucositis (Clinical Exam) - Oral Cavity * 1  5/36 (13.89%) 
Vomiting * 1  13/36 (36.11%) 
Anorexia * 1  10/36 (27.78%) 
Dehydration * 1  1/36 (2.78%) 
Constipation * 1  18/36 (50.00%) 
Nausea * 1  22/36 (61.11%) 
Gastrointestinal - Other * 1  2/36 (5.56%) 
Diarrhea * 1  13/36 (36.11%) 
General disorders   
Constitutional Symptoms - Other * 1  2/36 (5.56%) 
Sweating * 1  1/36 (2.78%) 
Weight Gain * 1  1/36 (2.78%) 
Fever * 1  3/36 (8.33%) 
Weight Loss * 1  5/36 (13.89%) 
Rigors/Chills * 1  3/36 (8.33%) 
Fatigue * 1  23/36 (63.89%) 
Insomnia * 1  3/36 (8.33%) 
Death No Ctcae Term - Disease Progression Nos * 1  1/36 (2.78%) 
Pain - Other * 1  3/36 (8.33%) 
Pain: Urethra * 1  1/36 (2.78%) 
Pain: Pelvis * 1  1/36 (2.78%) 
Pain: Vagina * 1  1/36 (2.78%) 
Pain: Chest /Thorax Nos * 1  3/36 (8.33%) 
Pain: Chest Wall * 1  1/36 (2.78%) 
Pain: Throat/Pharynx/Larynx * 1  1/36 (2.78%) 
Pain: Head/Headache * 1  23/36 (63.89%) 
Pain: Neck * 1  4/36 (11.11%) 
Pain: Extremity-Limb * 1  7/36 (19.44%) 
Pain: Back * 1  7/36 (19.44%) 
Pain: Joint * 1  9/36 (25.00%) 
Pain: Kidney * 1  1/36 (2.78%) 
Pain: Bladder * 1  1/36 (2.78%) 
Pain: Pain Nos * 1  1/36 (2.78%) 
Pain: Stomach * 1  1/36 (2.78%) 
Pain: Oral Cavity * 1  4/36 (11.11%) 
Pain: Abdominal Pain Nos * 1  18/36 (50.00%) 
Pain: Oral - Gums * 1  2/36 (5.56%) 
Pain: Skin * 1  1/36 (2.78%) 
Pain: Middle Ear * 1  1/36 (2.78%) 
Pain: Face * 1  1/36 (2.78%) 
Pain: Tumor * 1  1/36 (2.78%) 
Pain: Liver * 1  1/36 (2.78%) 
Pain: Muscle * 1  3/36 (8.33%) 
Flu-Like Syndrome * 1  1/36 (2.78%) 
Immune system disorders   
Allergy/Immunology - Other * 1  1/36 (2.78%) 
Allergic Reaction/Hypersensitivity * 1  1/36 (2.78%) 
Rhinitis * 1  11/36 (30.56%) 
Infections and infestations   
Inf W/Nml Or Gr 1 Or 2 Anc: Upper Airway Nos * 1  1/36 (2.78%) 
Inf Unknown Anc: Lung (Pneumonia) * 1  1/36 (2.78%) 
Inf Unknown Anc: Sinus * 1  2/36 (5.56%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Dental-Tooth * 1  1/36 (2.78%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos * 1  4/36 (11.11%) 
Inf Unknown Anc: Upper Airway Nos * 1  2/36 (5.56%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Vagina * 1  2/36 (5.56%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Sinus * 1  2/36 (5.56%) 
Inf Unknown Anc: Urinary Tract Nos * 1  2/36 (5.56%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Ureter * 1  1/36 (2.78%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Bladder * 1  2/36 (5.56%) 
Metabolism and nutrition disorders   
Ast * 1  7/36 (19.44%) 
Gfr * 1  1/36 (2.78%) 
Metabolic/Laboratory - Other * 1  4/36 (11.11%) 
Cholesterol,serum High * 1  1/36 (2.78%) 
Proteinuria * 1  6/36 (16.67%) 
Creatinine * 1  5/36 (13.89%) 
Hypoalbuminemia * 1  3/36 (8.33%) 
Ggt * 1  2/36 (5.56%) 
Alt * 1  4/36 (11.11%) 
Alkaline Phosphatase * 1  5/36 (13.89%) 
Bilirubin * 1  3/36 (8.33%) 
Hypermagnesemia * 1  1/36 (2.78%) 
Hypophosphatemia * 1  2/36 (5.56%) 
Hyponatremia * 1  3/36 (8.33%) 
Hyperuricemia * 1  1/36 (2.78%) 
Hypertriglyceridemia * 1  1/36 (2.78%) 
Bicarbonate, Serum-Low * 1  1/36 (2.78%) 
Acidosis * 1  1/36 (2.78%) 
Hypocalcemia * 1  4/36 (11.11%) 
Hyperkalemia * 1  2/36 (5.56%) 
Hyperglycemia * 1  11/36 (30.56%) 
Hypokalemia * 1  4/36 (11.11%) 
Hypoglycemia * 1  2/36 (5.56%) 
Hypercalcemia * 1  2/36 (5.56%) 
Hypomagnesemia * 1  8/36 (22.22%) 
Musculoskeletal and connective tissue disorders   
Trismus * 1  1/36 (2.78%) 
Joint-Function * 1  1/36 (2.78%) 
Arthritis * 1  2/36 (5.56%) 
Muscle Weakness - Whole Body/Generalized * 1  1/36 (2.78%) 
Muscle Weakness - Extremity-Lower * 1  1/36 (2.78%) 
Nervous system disorders   
Neurology - Other * 1  1/36 (2.78%) 
Mood Alteration - Depression * 1  5/36 (13.89%) 
Mood Alteration - Anxiety * 1  7/36 (19.44%) 
Mood Alteration - Agitation * 1  1/36 (2.78%) 
Memory Impairment * 1  1/36 (2.78%) 
Dizziness * 1  5/36 (13.89%) 
Neuropathy-Sensory * 1  15/36 (41.67%) 
Renal and urinary disorders   
Cystitis * 1  1/36 (2.78%) 
Incontinence, Urinary * 1  2/36 (5.56%) 
Urinary Frequency * 1  5/36 (13.89%) 
Reproductive system and breast disorders   
Libido * 1  2/36 (5.56%) 
Vaginal Discharge * 1  2/36 (5.56%) 
Respiratory, thoracic and mediastinal disorders   
Pulmonary: Other * 1  3/36 (8.33%) 
Nasal/Paranasal Reactions * 1  7/36 (19.44%) 
Voice Changes * 1  7/36 (19.44%) 
Hypoxia * 1  1/36 (2.78%) 
Cough * 1  6/36 (16.67%) 
Pneumonitis * 1  1/36 (2.78%) 
Pleural Effusion * 1  2/36 (5.56%) 
Dyspnea * 1  11/36 (30.56%) 
Skin and subcutaneous tissue disorders   
Nail Changes * 1  2/36 (5.56%) 
Injection Site Reaction * 1  1/36 (2.78%) 
Hair Loss/Alopecia (Scalp Or Body) * 1  5/36 (13.89%) 
Bruising * 1  1/36 (2.78%) 
Acne * 1  1/36 (2.78%) 
Rash * 1  12/36 (33.33%) 
Dry Skin * 1  7/36 (19.44%) 
Pruritus * 1  3/36 (8.33%) 
Flushing * 1  1/36 (2.78%) 
Dermatology/Skin - Other * 1  1/36 (2.78%) 
Hyperpigmentation * 1  3/36 (8.33%) 
Vascular disorders   
Inr * 1  1/36 (2.78%) 
Hemorrhage, Gu - Vagina * 1  1/36 (2.78%) 
Hemorrhage/Pulmonary - Bronchopulmonary Nos * 1  1/36 (2.78%) 
Hemorrhage, Gi - Rectum * 1  2/36 (5.56%) 
Hemorrhage/Pulmonary - Nose * 1  15/36 (41.67%) 
Hematoma * 1  1/36 (2.78%) 
Hemorrhage, Gi - Oral Cavity * 1  3/36 (8.33%) 
Thrombosis/Thrombus/Embolism * 1  1/36 (2.78%) 
*
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 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: Angela M. Kuras, Associate Director of Data Management
Organization: NRG Oncology Statistics and Data Management Center - Buffalo
Phone: 716-845-7733
EMail: kurasa@nrgoncology.org
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00748657     History of Changes
Other Study ID Numbers: NCI-2009-00611
NCI-2009-00611 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000613531
GOG-0251
GOG-0251 ( Other Identifier: NRG Oncology )
GOG-0251 ( Other Identifier: CTEP )
U10CA180868 ( U.S. NIH Grant/Contract )
U10CA027469 ( U.S. NIH Grant/Contract )
First Submitted: September 5, 2008
First Posted: September 8, 2008
Results First Submitted: May 27, 2015
Results First Posted: June 10, 2015
Last Update Posted: July 23, 2019