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Rilotumumab in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

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ClinicalTrials.gov Identifier: NCT01039207
Recruitment Status : Completed
First Posted : December 24, 2009
Results First Posted : September 7, 2017
Last Update Posted : September 7, 2017
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
Conditions Recurrent Fallopian Tube Carcinoma
Recurrent Ovarian Carcinoma
Recurrent Primary Peritoneal Carcinoma
Interventions Other: Laboratory Biomarker Analysis
Biological: Rilotumumab
Enrollment 31
Recruitment Details This trial was opened to patient entry on October 10, 2010 and was closed to accrual on May 10, 2011.
Pre-assignment Details  
Arm/Group Title AMG 102
Hide Arm/Group Description AMG 102 (rilotumumab) 20 mg/kg IV q 2 weeks until disease progression or adverse effects prohibit further therapy (cycle = 28 days)
Period Title: Overall Study
Started 31
Completed [1] 31
Not Completed 0
[1]
Eligible and treated patients.
Arm/Group Title AMG 102
Hide Arm/Group Description AMG 102 (rilotumumab) 20 mg/kg IV q 2 weeks until disease progression or adverse effects prohibit further therapy (cycle = 28 days)
Overall Number of Baseline Participants 31
Hide Baseline Analysis Population Description
Eligible and treated patients.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 31 participants
40-49 years 4
50-59 years 6
60-69 years 9
70-79 years 10
80-89 years 2
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
Female
31
 100.0%
Male
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
4
  12.9%
White
27
  87.1%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Proportion of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.1
Hide Description Complete and Partial Tumor Response by RECIST 1.1. RECIST 1.1 defines complete response as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm and the disappearance of all non-target lesions and normalization of tumor marker level. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response. 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 during treatment then every 3 months thereafter until disease progression is confirmed; also repeat at any time if clinically indicated up to 5 years.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated patients.
Arm/Group Title AMG 102
Hide Arm/Group Description:
AMG 102 (rilotumumab) 20 mg/kg IV q 2 weeks until disease progression or adverse effects prohibit further therapy (cycle = 28 days)
Overall Number of Participants Analyzed 31
Measure Type: Number
Unit of Measure: participants
Partial response 0
Complete response 1
2.Primary Outcome
Title Progression-free Survival > 6 Months Using RECIST 1.0
Hide Description Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression was based on RECIST 1.1. RECIST 1.1 defines progressive disease as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions or unequivocal progression of non-target lesions is also considered progression.
Time Frame CT scan or MRI if used to follow lesion for measurable disease every other cycle during treatment then every 3 months thereafter until disease progression is confirmed; up to 6 months.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated patients
Arm/Group Title AMG 102
Hide Arm/Group Description:
AMG 102 (rilotumumab) 20 mg/kg IV q 2 weeks until disease progression or adverse effects prohibit further therapy (cycle = 28 days)
Overall Number of Participants Analyzed 31
Measure Type: Number
Unit of Measure: participants
Patient with PFS>6 Months 2
Patients with PFS<6 months 29
3.Secondary Outcome
Title Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 4.0
Hide Description Number of participants with a maximum grade of 3 or higher during the treatment period.
Time Frame Assessed every cycle while on treatment, 30 days after the last cycle of treatment
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Hide Analysis Population Description
Eligible and treated patients.
Arm/Group Title AMG 102
Hide Arm/Group Description:
AMG 102 (rilotumumab) 20 mg/kg IV q 2 weeks until disease progression or adverse effects prohibit further therapy (cycle = 28 days)
Overall Number of Participants Analyzed 31
Measure Type: Number
Unit of Measure: participants
Leukopenia 1
Neutropenia 1
Cardiac 1
Nausea 2
Vomiting 4
Other Gastrointestinal 7
General and administration site 4
Hepatobiliary 1
Infections/infestations 2
Metabolism/nutrition 5
Respiratory/thoracic/mediastinal 1
Skin/subcutaneous 1
Vascular disorders 2
4.Secondary Outcome
Title Duration of Overall Survival (OS)
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 for the next 5 years.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated patients. Measure type = The first quartile of the distribution since follow-up time is insufficient to obtain adequate median estimates.
Arm/Group Title AMG 102
Hide Arm/Group Description:
AMG 102 (rilotumumab) 20 mg/kg IV q 2 weeks until disease progression or adverse effects prohibit further therapy (cycle = 28 days)
Overall Number of Participants Analyzed 31
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: months
4.3
(1.9 to 5.8)
5.Secondary Outcome
Title Duration of Progression-free Survival (PFS)
Hide Description Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression was based on RECIST 1.1. RECIST 1.1 defines progressive disease as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions or unequivocal progression of non-target lesions is also considered progression.
Time Frame CT scan or MRI if used to follow lesion for measurable disease every other cycle during treatment then every 3 months thereafter until disease progression is confirmed; also repeat at any time if clinically indicated up to 5 years.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated patients
Arm/Group Title AMG 102
Hide Arm/Group Description:
AMG 102 (rilotumumab) 20 mg/kg IV q 2 weeks until disease progression or adverse effects prohibit further therapy (cycle = 28 days)
Overall Number of Participants Analyzed 31
Median (90% Confidence Interval)
Unit of Measure: months
1.8
(1.7 to 1.9)
6.Other Pre-specified Outcome
Title Biomarker Panel From Tumor Tissue
Hide Description A panel of biomarkers from fixed and embedded tumor tissue will be tested for association with measures of response to treatment including PFS and OS.
Time Frame Baseline
Outcome Measure Data Not Reported
7.Other Pre-specified Outcome
Title Circulating Levels of HGF/Scatter Factor (SF)
Hide Description Exploratory analyses will be conducted to assess the possible effects of the study regimen on the biomarkers of interest as well as associations between the biomarkers and clinical outcome (such as PFS and OS).
Time Frame Up to 1 day prior to course 2
Outcome Measure Data Not Reported
8.Other Pre-specified Outcome
Title Circulating Levels of Markers of Angiogenesis
Hide Description Exploratory analyses will be conducted to assess the possible effects of the study regimen on the biomarkers of interest as well as associations between the biomarkers and clinical outcome (such as PFS and OS).
Time Frame Up to 1 day prior to course 2
Outcome Measure Data Not Reported
Time Frame Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AMG 102
Hide Arm/Group Description AMG 102 (rilotumumab) 20 mg/kg IV q 2 weeks until disease progression or adverse effects prohibit further therapy (cycle = 28 days)
All-Cause Mortality
AMG 102
Affected / at Risk (%)
Total   14/31 (45.16%) 
Show Serious Adverse Events Hide Serious Adverse Events
AMG 102
Affected / at Risk (%)
Total   14/31 (45.16%) 
Gastrointestinal disorders   
Diarrhea * 1  1/31 (3.23%) 
Vomiting * 1  3/31 (9.68%) 
Small Intestinal Obstruction * 1  1/31 (3.23%) 
Abdominal Pain * 1  3/31 (9.68%) 
Gastrointestinal Disorders - Other * 1  1/31 (3.23%) 
Ascites * 1  1/31 (3.23%) 
General disorders   
Death Nos * 1  3/31 (9.68%) 
Injury, poisoning and procedural complications   
Fall * 1  1/31 (3.23%) 
Metabolism and nutrition disorders   
Hyperglycemia * 1  1/31 (3.23%) 
Respiratory, thoracic and mediastinal disorders   
Pleural Effusion * 1  2/31 (6.45%) 
Vascular disorders   
Thromboembolic Event * 1  1/31 (3.23%) 
1
Term from vocabulary, CTCAE (4.0)
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
AMG 102
Affected / at Risk (%)
Total   31/31 (100.00%) 
Blood and lymphatic system disorders   
Anemia * 1  20/31 (64.52%) 
Cardiac disorders   
Atrial Fibrillation * 1  1/31 (3.23%) 
Ventricular Tachycardia * 1  1/31 (3.23%) 
Ear and labyrinth disorders   
Tinnitus * 1  1/31 (3.23%) 
Eye disorders   
Eye Disorders - Other * 1  1/31 (3.23%) 
Blurred Vision * 1  2/31 (6.45%) 
Gastrointestinal disorders   
Duodenal Obstruction * 1  1/31 (3.23%) 
Constipation * 1  8/31 (25.81%) 
Diarrhea * 1  6/31 (19.35%) 
Vomiting * 1  11/31 (35.48%) 
Bloating * 1  1/31 (3.23%) 
Small Intestinal Obstruction * 1  1/31 (3.23%) 
Abdominal Pain * 1  6/31 (19.35%) 
Obstruction Gastric * 1  1/31 (3.23%) 
Mucositis Oral * 1  1/31 (3.23%) 
Abdominal Distension * 1  3/31 (9.68%) 
Nausea * 1  14/31 (45.16%) 
Ascites * 1  2/31 (6.45%) 
General disorders   
Pain * 1  5/31 (16.13%) 
Localized Edema * 1  1/31 (3.23%) 
Edema Trunk * 1  1/31 (3.23%) 
Edema Limbs * 1  7/31 (22.58%) 
Fatigue * 1  19/31 (61.29%) 
Fever * 1  5/31 (16.13%) 
Hepatobiliary disorders   
Hepatobiliary Disorders - Other * 1  1/31 (3.23%) 
Infections and infestations   
Infections And Infestations - Other * 1  1/31 (3.23%) 
Skin Infection * 1  1/31 (3.23%) 
Sinusitis * 1  1/31 (3.23%) 
Peritoneal Infection * 1  1/31 (3.23%) 
Lung Infection * 1  1/31 (3.23%) 
Catheter Related Infection * 1  1/31 (3.23%) 
Injury, poisoning and procedural complications   
Wound Complication * 1  1/31 (3.23%) 
Investigations   
Weight Loss * 1  1/31 (3.23%) 
Platelet Count Decreased * 1  4/31 (12.90%) 
Inr Increased * 1  2/31 (6.45%) 
Creatinine Increased * 1  2/31 (6.45%) 
Neutrophil Count Decreased * 1  1/31 (3.23%) 
Blood Bilirubin Increased * 1  2/31 (6.45%) 
White Blood Cell Decreased * 1  5/31 (16.13%) 
Aspartate Aminotransferase Increased * 1  1/31 (3.23%) 
Alkaline Phosphatase Increased * 1  3/31 (9.68%) 
Alanine Aminotransferase Increased * 1  4/31 (12.90%) 
Activated Partial Thromboplastin Time Prolonged * 1  1/31 (3.23%) 
Metabolism and nutrition disorders   
Hypophosphatemia * 1  3/31 (9.68%) 
Hyponatremia * 1  7/31 (22.58%) 
Hypomagnesemia * 1  8/31 (25.81%) 
Hypokalemia * 1  5/31 (16.13%) 
Hypoglycemia * 1  1/31 (3.23%) 
Hypocalcemia * 1  5/31 (16.13%) 
Hypoalbuminemia * 1  7/31 (22.58%) 
Hypernatremia * 1  1/31 (3.23%) 
Hyperkalemia * 1  1/31 (3.23%) 
Hyperglycemia * 1  4/31 (12.90%) 
Dehydration * 1  2/31 (6.45%) 
Anorexia * 1  8/31 (25.81%) 
Musculoskeletal and connective tissue disorders   
Pain In Extremity * 1  3/31 (9.68%) 
Myalgia * 1  2/31 (6.45%) 
Generalized Muscle Weakness * 1  1/31 (3.23%) 
Buttock Pain * 1  1/31 (3.23%) 
Back Pain * 1  2/31 (6.45%) 
Arthritis * 1  1/31 (3.23%) 
Arthralgia * 1  3/31 (9.68%) 
Nervous system disorders   
Peripheral Sensory Neuropathy * 1  8/31 (25.81%) 
Peripheral Motor Neuropathy * 1  1/31 (3.23%) 
Neuralgia * 1  1/31 (3.23%) 
Memory Impairment * 1  1/31 (3.23%) 
Headache * 1  1/31 (3.23%) 
Dysgeusia * 1  1/31 (3.23%) 
Dizziness * 1  4/31 (12.90%) 
Psychiatric disorders   
Insomnia * 1  2/31 (6.45%) 
Depression * 1  2/31 (6.45%) 
Confusion * 1  1/31 (3.23%) 
Anxiety * 1  1/31 (3.23%) 
Renal and urinary disorders   
Urinary Incontinence * 1  1/31 (3.23%) 
Urinary Tract Pain * 1  1/31 (3.23%) 
Proteinuria * 1  2/31 (6.45%) 
Reproductive system and breast disorders   
Reproductive System And Breast Disorders - Other * 1  1/31 (3.23%) 
Pelvic Pain * 1  1/31 (3.23%) 
Respiratory, thoracic and mediastinal disorders   
Pleural Effusion * 1  3/31 (9.68%) 
Nasal Congestion * 1  1/31 (3.23%) 
Hypoxia * 1  1/31 (3.23%) 
Dyspnea * 1  9/31 (29.03%) 
Cough * 1  2/31 (6.45%) 
Skin and subcutaneous tissue disorders   
Skin And Subcutaneous Tissue Disorders - Other * 1  1/31 (3.23%) 
Pruritus * 1  2/31 (6.45%) 
Rash Maculo-Papular * 1  1/31 (3.23%) 
Nail Ridging * 1  1/31 (3.23%) 
Nail Loss * 1  1/31 (3.23%) 
Nail Discoloration * 1  2/31 (6.45%) 
Dry Skin * 1  1/31 (3.23%) 
Alopecia * 1  2/31 (6.45%) 
Vascular disorders   
Lymphedema * 1  1/31 (3.23%) 
Hypotension * 1  1/31 (3.23%) 
Hypertension * 1  1/31 (3.23%) 
1
Term from vocabulary, CTCAE (4.0)
*
Indicates events were collected by non-systematic assessment
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
Name/Title: Angela Kuras on behalf of Mike Sill, PhD
Organization: NRG Oncology
Phone: 716-845-5702
Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01039207     History of Changes
Other Study ID Numbers: GOG-0170P
NCI-2011-01996 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000662115
20070612
GOG-0170P ( Other Identifier: NRG Oncology )
GOG-0170P ( Other Identifier: CTEP )
U10CA180868 ( U.S. NIH Grant/Contract )
U10CA027469 ( U.S. NIH Grant/Contract )
First Submitted: December 22, 2009
First Posted: December 24, 2009
Results First Submitted: August 8, 2017
Results First Posted: September 7, 2017
Last Update Posted: September 7, 2017