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Pazopanib Hydrochloride in Treating Patients With Recurrent or Persistent Uterine Cancer

Primary Purpose

Recurrent Uterine Corpus Sarcoma, Uterine Carcinosarcoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pazopanib Hydrochloride
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Uterine Corpus Sarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients must have histologically confirmed uterine carcinosarcoma which is persistent or recurrent; acceptable histological type is defined as carcinosarcoma (malignant mixed müllerian tumor), homologous or heterologous type
  • Patients must have measurable disease

    • Measurable disease is defined by Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1)
    • Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded)
    • Each lesion must be greater than or equal to 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI), or caliper measurement by clinical exam or greater than or equal to 20 mm when measured by chest x-ray
    • Lymph nodes must be greater than or equal to 15 mm in short axis when measured by CT or MRI
  • Patients must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST version 1.1

    • Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
  • Patients must not be eligible for a higher priority Gynecologic Oncology Group (GOG) protocol, if one exists

    • In general, this would refer to any active GOG phase III protocol or rare tumor protocol for the same patient population
  • Patients must have a GOG performance status of 0, 1, or 2
  • Recovery from effects of recent surgery, radiotherapy, or chemotherapy

    • Patients should be free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection [UTI])
    • Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration
    • Any other prior therapy (chemotherapy) directed at the malignant tumor, must be discontinued at least three weeks prior to registration
    • At least 4 weeks must have elapsed since the patient underwent any major surgery (e.g., major: hysterectomy, resection of a lung nodule - minor: central venous access catheter placement)
  • Patients must have had one prior chemotherapeutic regimen for management of carcinosarcoma; initial treatment may include chemotherapy, chemotherapy and radiation therapy, and/or consolidation/maintenance therapy; chemotherapy administered in conjunction with primary radiation as a radio-sensitizer WILL be counted as a systemic chemotherapy regimen
  • Patients are allowed to receive, but are not required to receive, one additional cytotoxic regimen for management of recurrent or persistent disease according to the following definition:

    • Cytotoxic regimens include any agent that targets the genetic and/or mitotic apparatus of dividing cells, resulting in dose-limiting toxicity to the bone marrow and/or gastrointestinal mucosa
    • Note: patients on this non-cytotoxic study are allowed to receive one additional cytotoxic chemotherapy regimen for management of recurrent or persistent disease, as defined above; however, due to the novel nature of biologic compounds, patients are encouraged to enroll on second-line non-cytotoxic studies prior to receiving additional cytotoxic therapy
    • Patients must have NOT received any non-cytotoxic chemotherapy for management of recurrent or persistent disease; prior hormonal therapy is permitted
  • Absolute neutrophil count (ANC) greater than or equal to 1,500/mcL
  • Platelets greater than or equal to 100,000/mcL
  • Hemoglobin level greater than or equal to 9 g/dL
  • Creatinine less than or equal to 1.5 x institutional upper limit of normal (ULN)
  • Urine protein/creatinine ratio (UPCR) must be less than 1 (or urinary protein less than 1.0 g/24 hours)
  • Bilirubin less than or equal to 1.5 x ULN (subjects with Gilbert syndrome and elevations of indirect bilirubin only are eligible)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 2.5 x ULN
  • Alkaline phosphatase less than or equal to 2.5 x ULN
  • Subjects who have BOTH bilirubin greater than ULN and AST/ALT greater than ULN are not eligible

    • Specifically, if bilirubin is greater than 1 x ULN but less than or equal to 1.5 x ULN, THEN the AST and ALT must be less than or equal to ULN for patient to be eligible; if AST and/or ALT are greater than 1 x ULN but less than or equal to 2.5 x ULN, THEN the bilirubin must be less than or equal to ULN for patient to be eligible
  • Prothrombin time (PT) such that international normalized ratio (INR) is less than or equal to 1.5 x ULN (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin) and a partial thromboplastin time (PTT) less than or equal to 1.5 x ULN
  • Patients with a history of hypothyroidism/hyperthyroidism must have had stable well-controlled thyroid function for a minimum of 2 months as a condition for eligibility and that all other patients must have normal baseline thyroid function tests (thyroid stimulating hormone [TSH], triiodothyronine [T]3, T4)
  • Patients must have the ability to understand and sign an approved informed consent and authorization permitting release of personal health information
  • Patients who have met the pre-entry requirements
  • Patients must be capable of taking and absorbing oral medications; a patient must be clear of the following:

    • Any lesion, whether induced by tumor, radiation or other conditions, which makes it difficult to swallow tablets
    • Prior surgical procedures affecting absorption including, but not limited to major resection of stomach or small bowel
    • Active peptic ulcer disease
    • Malabsorption syndrome
  • Patients must be capable of taking and absorbing oral medications
  • A patient must be clear of the following:

    • Any lesion, whether induced by tumor, radiation, or other conditions, which makes it difficult to swallow tablets
    • Prior surgical procedures affecting absorption including, but not limited to, major resection of stomach or small bowel
    • Active peptic ulcer disease
    • Malabsorption syndrome
  • Any concomitant medications that are associated with a risk of corrected QC (QTc) prolongation and/or Torsades de pointes should be discontinued or replaced with drugs that do not carry these risks, if possible; patients who must take medication with a risk of possible risk of Torsades de pointes should be watched carefully for symptoms of QTc prolongation, such as syncope

    • Patients with personal or family history of congenital long QTc syndrome are NOT eligible
  • Strong inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) are prohibited; grapefruit juice is also an inhibitor of CYP450 and should not be taken with pazopanib; CYP3A4 Inducers: strong inducers of CYP3A4 are prohibited; cytochrome P450 (CYP) substrates: concomitant use of agents with narrow therapeutic windows that are metabolized by CYP3A4, cytochrome P450, family 2, subfamily D, polypeptide 6 (CYP2D6), or cytochrome P450, family 2, subfamily C, poly peptide 8 (CYP2C8) is not recommended
  • Patients of childbearing potential must have a negative pregnancy test prior to the study treatment and agree to be practicing an effective form of contraception throughout study treatment; pregnant women are excluded from this study

Exclusion Criteria:

  • Patients who have had prior therapy with pazopanib
  • Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last three years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
  • Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis OTHER THAN for the treatment of uterine carcinosarcoma within the last three years are excluded; prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease
  • Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of uterine carcinosarcoma within the last three years are excluded; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease
  • Patients with clinically significant cardiovascular disease; this includes:

    • Patients must have blood pressure (BP) no greater than 140 mmHg (systolic) and 90 mmHg (diastolic) for eligibility
    • Myocardial infarction or unstable angina within 6 months of the first date of pazopanib therapy
    • New York Heart Association (NYHA) class II or greater congestive heart failure
    • History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation) or cardiac arrhythmias requiring anti-arrhythmic medications; this does not include asymptomatic, atrial fibrillation with controlled ventricular rate
    • Women who have received prior anthracycline (e.g., doxorubicin and/or liposomal doxorubicin) and who have an ejection fraction less than the institutional lower limit of normal will be excluded from the study; patients with a prior life time exposure to doxorubicin (or liposomal doxorubicin) of greater than 300 mg/m^2 are NOT eligible
    • CTCAE grade 2 or greater peripheral vascular disease
    • History of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of pazopanib therapy
    • Women with a baseline QTc >= 480 milliseconds
    • History of cardiac angioplasty or stenting within 6 months prior to registration; history of coronary artery bypass graft surgery within 6 months prior to registration
    • A patient with arterial thrombosis within 6 months prior to enrollment
  • Patients with history or evidence upon physical examination of central nervous system (CNS) disease, including primary brain tumor, seizures not controlled with standard medical therapy or any brain metastases
  • Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels
  • Patients with serious, non-healing wound, ulcer, or bone fracture; this includes history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days prior to the first date of pazopanib therapy; patients with underlying lesions that caused the fistula or perforation in the past that have not been corrected
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to pazopanib
  • Human immunodeficiency virus (HIV)-positive subjects on combination antiretroviral therapy are ineligible
  • Patients who are nursing; patients who are lactating should discontinue nursing prior to the first dose of study drug and should refrain from nursing throughout the treatment period and for 14 days following the last dose of study drug
  • Patients with any condition that may increase the risk of gastrointestinal bleeding or gastrointestinal perforation, including:

    • Active peptic ulcer disease
    • Known gastrointestinal intraluminal metastatic lesions (gastrointestinal serosa metastatic lesion are permitted)
    • Inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease)
  • History of hemoptysis in excess of 2.5 mL (1/2 teaspoon) within 8 weeks prior to first dose of pazopanib
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements

Sites / Locations

  • University of Colorado Cancer Center - Anschutz Cancer Pavilion
  • Smilow Cancer Hospital Care Center at Saint Francis
  • The Hospital of Central Connecticut
  • MedStar Washington Hospital Center
  • Florida Hospital Orlando
  • University of Chicago Comprehensive Cancer Center
  • Sudarshan K Sharma MD Limted-Gynecologic Oncology
  • Indiana University/Melvin and Bren Simon Cancer Center
  • Saint Vincent Oncology Center
  • MedStar Franklin Square Medical Center/Weinberg Cancer Institute
  • Saint Joseph Mercy Hospital
  • Michigan Cancer Research Consortium CCOP
  • Oakwood Hospital and Medical Center
  • Saint John Hospital and Medical Center
  • Hurley Medical Center
  • Genesys Regional Medical Center-West Flint Campus
  • Genesys Regional Medical Center
  • Allegiance Health
  • Sparrow Hospital
  • Saint Mary Mercy Hospital
  • Saint Joseph Mercy Oakland
  • Saint Joseph Mercy Port Huron
  • Saint Mary's of Michigan
  • Saint John Macomb-Oakland Hospital
  • Cancer Research for the Ozarks NCORP
  • CoxHealth South Hospital
  • Nebraska Methodist Hospital
  • Cooper Hospital University Medical Center
  • Memorial Sloan-Kettering Cancer Center
  • UNC Lineberger Comprehensive Cancer Center
  • Carolinas Medical Center/Levine Cancer Institute
  • Novant Health Presbyterian Medical Center
  • Duke University Medical Center
  • Case Western Reserve University
  • MetroHealth Medical Center
  • Riverside Methodist Hospital
  • Lake University Ireland Cancer Center
  • University of Oklahoma Health Sciences Center
  • Oklahoma Cancer Specialists and Research Institute-Tulsa
  • Abington Memorial Hospital
  • Women and Infants Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (pazopanib hydrochloride)

Arm Description

Patients receive pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Objective Tumor Response (Complete or Partial)
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
Percentage of Participants With Progression-free Survival (PFS) at 6 Months
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.
Number of Patients With Grade 3 or Higher Adverse Events
Grade 3 or higher adverse events were graded by CTCAE v4.

Secondary Outcome Measures

Progression-free Survival
Progression-free survival is the period from study entry until disease progression, death or date of last contact
Overall Survival
The observed length of life from entry into the study to death or the date of last contact.

Full Information

First Posted
November 23, 2010
Last Updated
August 6, 2019
Sponsor
National Cancer Institute (NCI)
Collaborators
NRG Oncology
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1. Study Identification

Unique Protocol Identification Number
NCT01247571
Brief Title
Pazopanib Hydrochloride in Treating Patients With Recurrent or Persistent Uterine Cancer
Official Title
A Phase II Evaluation of Pazopanib (NSC # 737754) in the Treatment of Recurrent or Persistent Carcinosarcoma of the Uterus
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)
Collaborators
NRG Oncology

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This phase II trial studies how well pazopanib hydrochloride works in treating patients with uterine cancer that has come back or has not responded to treatment. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Pazopanib hydrochloride may also stop the growth of uterine cancer by blocking blood flow to the tumor.
Detailed Description
PRIMARY OBJECTIVES: I. To assess the activity of pazopanib in patients with persistent or recurrent carcinosarcoma of the uterus as measured by the proportion of patients who survive progression-free for at least 6 months and the proportion of patients who have objective tumor response (complete or partial). SECONDARY OBJECTIVES: I. To determine the frequency and severity of adverse events as assessed by Common Terminology Criteria of Adverse Events version 4.0 (CTCAE v4.0). II. To determine the duration of progression-free survival and overall survival. OUTLINE: This is a multicenter study. Patients receive pazopanib hydrochloride orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Uterine Corpus Sarcoma, Uterine Carcinosarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (pazopanib hydrochloride)
Arm Type
Experimental
Arm Description
Patients receive pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
Pazopanib Hydrochloride
Other Intervention Name(s)
GW786034B, Votrient
Intervention Description
Given PO
Primary Outcome Measure Information:
Title
Objective Tumor Response (Complete or Partial)
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.
Title
Percentage of Participants With Progression-free Survival (PFS) at 6 Months
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
Title
Number of Patients With Grade 3 or Higher Adverse Events
Description
Grade 3 or higher adverse events were graded by CTCAE v4.
Time Frame
Every cycle while on treatment
Secondary Outcome Measure Information:
Title
Progression-free Survival
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
Title
Overall Survival
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must have histologically confirmed uterine carcinosarcoma which is persistent or recurrent; acceptable histological type is defined as carcinosarcoma (malignant mixed müllerian tumor), homologous or heterologous type Patients must have measurable disease Measurable disease is defined by Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1) Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) Each lesion must be greater than or equal to 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI), or caliper measurement by clinical exam or greater than or equal to 20 mm when measured by chest x-ray Lymph nodes must be greater than or equal to 15 mm in short axis when measured by CT or MRI Patients must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST version 1.1 Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy Patients must not be eligible for a higher priority Gynecologic Oncology Group (GOG) protocol, if one exists In general, this would refer to any active GOG phase III protocol or rare tumor protocol for the same patient population Patients must have a GOG performance status of 0, 1, or 2 Recovery from effects of recent surgery, radiotherapy, or chemotherapy Patients should be free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection [UTI]) Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration Any other prior therapy (chemotherapy) directed at the malignant tumor, must be discontinued at least three weeks prior to registration At least 4 weeks must have elapsed since the patient underwent any major surgery (e.g., major: hysterectomy, resection of a lung nodule - minor: central venous access catheter placement) Patients must have had one prior chemotherapeutic regimen for management of carcinosarcoma; initial treatment may include chemotherapy, chemotherapy and radiation therapy, and/or consolidation/maintenance therapy; chemotherapy administered in conjunction with primary radiation as a radio-sensitizer WILL be counted as a systemic chemotherapy regimen Patients are allowed to receive, but are not required to receive, one additional cytotoxic regimen for management of recurrent or persistent disease according to the following definition: Cytotoxic regimens include any agent that targets the genetic and/or mitotic apparatus of dividing cells, resulting in dose-limiting toxicity to the bone marrow and/or gastrointestinal mucosa Note: patients on this non-cytotoxic study are allowed to receive one additional cytotoxic chemotherapy regimen for management of recurrent or persistent disease, as defined above; however, due to the novel nature of biologic compounds, patients are encouraged to enroll on second-line non-cytotoxic studies prior to receiving additional cytotoxic therapy Patients must have NOT received any non-cytotoxic chemotherapy for management of recurrent or persistent disease; prior hormonal therapy is permitted Absolute neutrophil count (ANC) greater than or equal to 1,500/mcL Platelets greater than or equal to 100,000/mcL Hemoglobin level greater than or equal to 9 g/dL Creatinine less than or equal to 1.5 x institutional upper limit of normal (ULN) Urine protein/creatinine ratio (UPCR) must be less than 1 (or urinary protein less than 1.0 g/24 hours) Bilirubin less than or equal to 1.5 x ULN (subjects with Gilbert syndrome and elevations of indirect bilirubin only are eligible) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 2.5 x ULN Alkaline phosphatase less than or equal to 2.5 x ULN Subjects who have BOTH bilirubin greater than ULN and AST/ALT greater than ULN are not eligible Specifically, if bilirubin is greater than 1 x ULN but less than or equal to 1.5 x ULN, THEN the AST and ALT must be less than or equal to ULN for patient to be eligible; if AST and/or ALT are greater than 1 x ULN but less than or equal to 2.5 x ULN, THEN the bilirubin must be less than or equal to ULN for patient to be eligible Prothrombin time (PT) such that international normalized ratio (INR) is less than or equal to 1.5 x ULN (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin) and a partial thromboplastin time (PTT) less than or equal to 1.5 x ULN Patients with a history of hypothyroidism/hyperthyroidism must have had stable well-controlled thyroid function for a minimum of 2 months as a condition for eligibility and that all other patients must have normal baseline thyroid function tests (thyroid stimulating hormone [TSH], triiodothyronine [T]3, T4) Patients must have the ability to understand and sign an approved informed consent and authorization permitting release of personal health information Patients who have met the pre-entry requirements Patients must be capable of taking and absorbing oral medications; a patient must be clear of the following: Any lesion, whether induced by tumor, radiation or other conditions, which makes it difficult to swallow tablets Prior surgical procedures affecting absorption including, but not limited to major resection of stomach or small bowel Active peptic ulcer disease Malabsorption syndrome Patients must be capable of taking and absorbing oral medications A patient must be clear of the following: Any lesion, whether induced by tumor, radiation, or other conditions, which makes it difficult to swallow tablets Prior surgical procedures affecting absorption including, but not limited to, major resection of stomach or small bowel Active peptic ulcer disease Malabsorption syndrome Any concomitant medications that are associated with a risk of corrected QC (QTc) prolongation and/or Torsades de pointes should be discontinued or replaced with drugs that do not carry these risks, if possible; patients who must take medication with a risk of possible risk of Torsades de pointes should be watched carefully for symptoms of QTc prolongation, such as syncope Patients with personal or family history of congenital long QTc syndrome are NOT eligible Strong inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) are prohibited; grapefruit juice is also an inhibitor of CYP450 and should not be taken with pazopanib; CYP3A4 Inducers: strong inducers of CYP3A4 are prohibited; cytochrome P450 (CYP) substrates: concomitant use of agents with narrow therapeutic windows that are metabolized by CYP3A4, cytochrome P450, family 2, subfamily D, polypeptide 6 (CYP2D6), or cytochrome P450, family 2, subfamily C, poly peptide 8 (CYP2C8) is not recommended Patients of childbearing potential must have a negative pregnancy test prior to the study treatment and agree to be practicing an effective form of contraception throughout study treatment; pregnant women are excluded from this study Exclusion Criteria: Patients who have had prior therapy with pazopanib Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last three years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis OTHER THAN for the treatment of uterine carcinosarcoma within the last three years are excluded; prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of uterine carcinosarcoma within the last three years are excluded; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease Patients with clinically significant cardiovascular disease; this includes: Patients must have blood pressure (BP) no greater than 140 mmHg (systolic) and 90 mmHg (diastolic) for eligibility Myocardial infarction or unstable angina within 6 months of the first date of pazopanib therapy New York Heart Association (NYHA) class II or greater congestive heart failure History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation) or cardiac arrhythmias requiring anti-arrhythmic medications; this does not include asymptomatic, atrial fibrillation with controlled ventricular rate Women who have received prior anthracycline (e.g., doxorubicin and/or liposomal doxorubicin) and who have an ejection fraction less than the institutional lower limit of normal will be excluded from the study; patients with a prior life time exposure to doxorubicin (or liposomal doxorubicin) of greater than 300 mg/m^2 are NOT eligible CTCAE grade 2 or greater peripheral vascular disease History of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of pazopanib therapy Women with a baseline QTc >= 480 milliseconds History of cardiac angioplasty or stenting within 6 months prior to registration; history of coronary artery bypass graft surgery within 6 months prior to registration A patient with arterial thrombosis within 6 months prior to enrollment Patients with history or evidence upon physical examination of central nervous system (CNS) disease, including primary brain tumor, seizures not controlled with standard medical therapy or any brain metastases Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels Patients with serious, non-healing wound, ulcer, or bone fracture; this includes history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days prior to the first date of pazopanib therapy; patients with underlying lesions that caused the fistula or perforation in the past that have not been corrected History of allergic reactions attributed to compounds of similar chemical or biologic composition to pazopanib Human immunodeficiency virus (HIV)-positive subjects on combination antiretroviral therapy are ineligible Patients who are nursing; patients who are lactating should discontinue nursing prior to the first dose of study drug and should refrain from nursing throughout the treatment period and for 14 days following the last dose of study drug Patients with any condition that may increase the risk of gastrointestinal bleeding or gastrointestinal perforation, including: Active peptic ulcer disease Known gastrointestinal intraluminal metastatic lesions (gastrointestinal serosa metastatic lesion are permitted) Inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease) History of hemoptysis in excess of 2.5 mL (1/2 teaspoon) within 8 weeks prior to first dose of pazopanib Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susana Campos
Organizational Affiliation
NRG Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Cancer Center - Anschutz Cancer Pavilion
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Smilow Cancer Hospital Care Center at Saint Francis
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06105
Country
United States
Facility Name
The Hospital of Central Connecticut
City
New Britain
State/Province
Connecticut
ZIP/Postal Code
06050
Country
United States
Facility Name
MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Florida Hospital Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
University of Chicago Comprehensive Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Sudarshan K Sharma MD Limted-Gynecologic Oncology
City
Hinsdale
State/Province
Illinois
ZIP/Postal Code
60521
Country
United States
Facility Name
Indiana University/Melvin and Bren Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Saint Vincent Oncology Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
MedStar Franklin Square Medical Center/Weinberg Cancer Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Saint Joseph Mercy Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106-0995
Country
United States
Facility Name
Michigan Cancer Research Consortium CCOP
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
Oakwood Hospital and Medical Center
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48124
Country
United States
Facility Name
Saint John Hospital and Medical Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
Hurley Medical Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48502
Country
United States
Facility Name
Genesys Regional Medical Center-West Flint Campus
City
Flint
State/Province
Michigan
ZIP/Postal Code
48532
Country
United States
Facility Name
Genesys Regional Medical Center
City
Grand Blanc
State/Province
Michigan
ZIP/Postal Code
48439
Country
United States
Facility Name
Allegiance Health
City
Jackson
State/Province
Michigan
ZIP/Postal Code
49201
Country
United States
Facility Name
Sparrow Hospital
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912
Country
United States
Facility Name
Saint Mary Mercy Hospital
City
Livonia
State/Province
Michigan
ZIP/Postal Code
48154
Country
United States
Facility Name
Saint Joseph Mercy Oakland
City
Pontiac
State/Province
Michigan
ZIP/Postal Code
48341
Country
United States
Facility Name
Saint Joseph Mercy Port Huron
City
Port Huron
State/Province
Michigan
ZIP/Postal Code
48060
Country
United States
Facility Name
Saint Mary's of Michigan
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48601
Country
United States
Facility Name
Saint John Macomb-Oakland Hospital
City
Warren
State/Province
Michigan
ZIP/Postal Code
48093
Country
United States
Facility Name
Cancer Research for the Ozarks NCORP
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
CoxHealth South Hospital
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Nebraska Methodist Hospital
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Cooper Hospital University Medical Center
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
UNC Lineberger Comprehensive Cancer Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Carolinas Medical Center/Levine Cancer Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Novant Health Presbyterian Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Case Western Reserve University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Riverside Methodist Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Lake University Ireland Cancer Center
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Oklahoma Cancer Specialists and Research Institute-Tulsa
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74146
Country
United States
Facility Name
Abington Memorial Hospital
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Facility Name
Women and Infants Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Pazopanib Hydrochloride in Treating Patients With Recurrent or Persistent Uterine Cancer

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