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Pazopanib Hydrochloride in Treating Patients With Recurrent or Persistent Uterine 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: NCT01247571
Recruitment Status : Completed
First Posted : November 24, 2010
Results First Posted : July 27, 2017
Last Update Posted : August 8, 2019
Sponsor:
Collaborator:
NRG Oncology
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Recurrent Uterine Corpus Sarcoma
Uterine Carcinosarcoma
Intervention Drug: Pazopanib Hydrochloride
Enrollment 22
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pazopanib
Hide Arm/Group Description Pazopanib 800mg daily until disease progression or adverse effects prohibit further therapy (one cycle equals 28 days)
Period Title: Overall Study
Started 22
Completed 19
Not Completed 3
Arm/Group Title Pazopanib
Hide Arm/Group Description Pazopanib 800mg daily until disease progression or adverse effects prohibit further therapy (one cycle equals 28 days)
Overall Number of Baseline Participants 19
Hide Baseline Analysis Population Description
Eligible and treated patients
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 19 participants
50-59 1
60-69 11
70-79 7
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
Female
19
 100.0%
Male
0
   0.0%
1.Primary Outcome
Title Objective Tumor Response (Complete or Partial)
Hide Description Complete and Partial Tumor Response by RECIST 1.0. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Time Frame CT scan or MRI if used to follow lesion(s) for measurable disease every other cycle for the first 6 mnths; then every 3 mnths thereafter until dx progression is confirmed; also repeat any other time clinically indicated, assessed up to 6 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and Treated Patients
Arm/Group Title Pazopanib
Hide Arm/Group Description:
Pazopanib 800mg daily until disease progression or adverse effects prohibit further therapy (one cycle equals 28 days)
Overall Number of Participants Analyzed 19
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
0
(0 to 14.6)
2.Primary Outcome
Title Percentage of Participants With Progression-free Survival (PFS) at 6 Months
Hide Description Progression-free survival is the period from study entry until disease progression, death or date of last contact. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 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 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated patients
Arm/Group Title Pazopanib
Hide Arm/Group Description:
Pazopanib 800mg daily until disease progression or adverse effects prohibit further therapy (one cycle equals 28 days)
Overall Number of Participants Analyzed 19
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
15.8
(4.4 to 35.9)
3.Primary Outcome
Title Number of Patients With Grade 3 or Higher Adverse Events
Hide Description Grade 3 or higher adverse events were graded by CTCAE v4.
Time Frame Every cycle while on treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and Treated Patients
Arm/Group Title Pazopanib
Hide Arm/Group Description:
Pazopanib 800mg daily until disease progression or adverse effects prohibit further therapy (one cycle equals 28 days)
Overall Number of Participants Analyzed 19
Measure Type: Number
Unit of Measure: participants
Anemia 3
Hypertension 3
Abdominal pain 2
Hyperglycemia 2
Hypoglycemia 2
Alanine aminotransferase increased 1
Ascites 1
Aspartate aminotransferase increased 1
Creatinine increasead 1
Death NOS 1
Dehydration 1
Diarrhea 1
Dyspnea 1
Fatigue 1
Headache 1
Hypocalcemia 1
Hyponatremia 1
Memory impairment 1
Nausea 1
Proctitis 1
Rectal hemorrhage 1
Sepsis 1
Vomiting 1
4.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 From start of treatment to time of progression or death, assessed up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and Treated Patients
Arm/Group Title Pazopanib
Hide Arm/Group Description:
Pazopanib 800mg daily until disease progression or adverse effects prohibit further therapy (one cycle equals 28 days)
Overall Number of Participants Analyzed 19
Median (95% Confidence Interval)
Unit of Measure: months
2.0
(1.6 to 3.6)
5.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 Time from start of treatment to time of death or the date of last contact, assessed up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated patients
Arm/Group Title Pazopanib
Hide Arm/Group Description:
Pazopanib 800mg daily until disease progression or adverse effects prohibit further therapy (one cycle equals 28 days)
Overall Number of Participants Analyzed 19
Median (95% Confidence Interval)
Unit of Measure: months
8.7
(2.6 to 14.0)
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) for up to 5 years after stopping study treatment.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pazopanib
Hide Arm/Group Description Pazopanib 800mg daily until disease progression or adverse effects prohibit further therapy (one cycle equals 28 days)
All-Cause Mortality
Pazopanib
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Pazopanib
Affected / at Risk (%)
Total   6/19 (31.58%) 
Blood and lymphatic system disorders   
Anemia * 1  1/19 (5.26%) 
Gastrointestinal disorders   
Abdominal Pain * 1  1/19 (5.26%) 
General disorders   
Death Nos * 1  1/19 (5.26%) 
Investigations   
Creatinine Increased * 1  1/19 (5.26%) 
Metabolism and nutrition disorders   
Hypomagnesemia * 1  1/19 (5.26%) 
Dehydration * 1  1/19 (5.26%) 
Nervous system disorders   
Memory Impairment * 1  1/19 (5.26%) 
Reproductive system and breast disorders   
Reproductive System And Breast Disorders - Other * 1  1/19 (5.26%) 
*
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%
Pazopanib
Affected / at Risk (%)
Total   19/19 (100.00%) 
Blood and lymphatic system disorders   
Anemia * 1  9/19 (47.37%) 
Cardiac disorders   
Sinus Bradycardia * 1  1/19 (5.26%) 
Sinus Tachycardia * 1  1/19 (5.26%) 
Ear and labyrinth disorders   
Tinnitus * 1  2/19 (10.53%) 
Hearing Impaired * 1  2/19 (10.53%) 
Ear Pain * 1  1/19 (5.26%) 
Eye disorders   
Blurred Vision * 1  3/19 (15.79%) 
Gastrointestinal disorders   
Dysphagia * 1  3/19 (15.79%) 
Dyspepsia * 1  1/19 (5.26%) 
Dry Mouth * 1  3/19 (15.79%) 
Constipation * 1  7/19 (36.84%) 
Diarrhea * 1  13/19 (68.42%) 
Vomiting * 1  8/19 (42.11%) 
Bloating * 1  1/19 (5.26%) 
Abdominal Pain * 1  7/19 (36.84%) 
Proctitis * 1  1/19 (5.26%) 
Rectal Hemorrhage * 1  2/19 (10.53%) 
Mucositis Oral * 1  1/19 (5.26%) 
Gastrointestinal Pain * 1  1/19 (5.26%) 
Oral Pain * 1  1/19 (5.26%) 
Nausea * 1  15/19 (78.95%) 
Gastroesophageal Reflux Disease * 1  2/19 (10.53%) 
Ascites * 1  1/19 (5.26%) 
Flatulence * 1  1/19 (5.26%) 
General disorders   
Pain * 1  1/19 (5.26%) 
Edema Trunk * 1  1/19 (5.26%) 
Edema Limbs * 1  1/19 (5.26%) 
Fatigue * 1  14/19 (73.68%) 
Fever * 1  1/19 (5.26%) 
Infections and infestations   
Sinusitis * 1  1/19 (5.26%) 
Sepsis * 1  1/19 (5.26%) 
Urinary Tract Infection * 1  1/19 (5.26%) 
Injury, poisoning and procedural complications   
Bruising * 1  1/19 (5.26%) 
Investigations   
Investigations - Other * 1  1/19 (5.26%) 
Weight Loss * 1  4/19 (21.05%) 
Platelet Count Decreased * 1  2/19 (10.53%) 
Lymphocyte Count Decreased * 1  1/19 (5.26%) 
Creatinine Increased * 1  2/19 (10.53%) 
Neutrophil Count Decreased * 1  10/19 (52.63%) 
Blood Bilirubin Increased * 1  3/19 (15.79%) 
White Blood Cell Decreased * 1  10/19 (52.63%) 
Aspartate Aminotransferase Increased * 1  4/19 (21.05%) 
Alkaline Phosphatase Increased * 1  3/19 (15.79%) 
Alanine Aminotransferase Increased * 1  4/19 (21.05%) 
Metabolism and nutrition disorders   
Hyponatremia * 1  4/19 (21.05%) 
Hypomagnesemia * 1  3/19 (15.79%) 
Hypokalemia * 1  2/19 (10.53%) 
Hypoglycemia * 1  2/19 (10.53%) 
Hypocalcemia * 1  3/19 (15.79%) 
Hypoalbuminemia * 1  4/19 (21.05%) 
Hyperglycemia * 1  2/19 (10.53%) 
Dehydration * 1  1/19 (5.26%) 
Anorexia * 1  6/19 (31.58%) 
Musculoskeletal and connective tissue disorders   
Pain In Extremity * 1  4/19 (21.05%) 
Neck Pain * 1  2/19 (10.53%) 
Generalized Muscle Weakness * 1  2/19 (10.53%) 
Back Pain * 1  1/19 (5.26%) 
Arthritis * 1  1/19 (5.26%) 
Arthralgia * 1  3/19 (15.79%) 
Nervous system disorders   
Peripheral Sensory Neuropathy * 1  8/19 (42.11%) 
Paresthesia * 1  1/19 (5.26%) 
Memory Impairment * 1  3/19 (15.79%) 
Headache * 1  6/19 (31.58%) 
Dysgeusia * 1  1/19 (5.26%) 
Dizziness * 1  2/19 (10.53%) 
Psychiatric disorders   
Insomnia * 1  3/19 (15.79%) 
Depression * 1  4/19 (21.05%) 
Anxiety * 1  2/19 (10.53%) 
Renal and urinary disorders   
Urinary Retention * 1  1/19 (5.26%) 
Urinary Frequency * 1  2/19 (10.53%) 
Proteinuria * 1  1/19 (5.26%) 
Reproductive system and breast disorders   
Vaginal Hemorrhage * 1  2/19 (10.53%) 
Pelvic Pain * 1  1/19 (5.26%) 
Vaginal Discharge * 1  2/19 (10.53%) 
Respiratory, thoracic and mediastinal disorders   
Epistaxis * 1  3/19 (15.79%) 
Dyspnea * 1  6/19 (31.58%) 
Cough * 1  5/19 (26.32%) 
Allergic Rhinitis * 1  1/19 (5.26%) 
Skin and subcutaneous tissue disorders   
Skin And Subcutaneous Tissue Disorders - Other * 1  1/19 (5.26%) 
Rash Maculo-Papular * 1  2/19 (10.53%) 
Skin Hypopigmentation * 1  2/19 (10.53%) 
Nail Discoloration * 1  1/19 (5.26%) 
Dry Skin * 1  1/19 (5.26%) 
Alopecia * 1  4/19 (21.05%) 
Vascular disorders   
Hypertension * 1  10/19 (52.63%) 
*
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 William Brady, PhD.
Organization: NRG Oncology
Phone: 716-845-1169
EMail: lgedeon@gogstats.org
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01247571    
Other Study ID Numbers: NCI-2011-02658
NCI-2011-02658 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
GOG-0230D
CDR0000689585
GOG-0230D ( Other Identifier: NRG Oncology )
GOG-0230D ( Other Identifier: CTEP )
U10CA180868 ( U.S. NIH Grant/Contract )
U10CA027469 ( U.S. NIH Grant/Contract )
First Submitted: November 23, 2010
First Posted: November 24, 2010
Results First Submitted: February 10, 2017
Results First Posted: July 27, 2017
Last Update Posted: August 8, 2019