Pazopanib Hydrochloride in Treating Patients With Recurrent or Persistent Uterine Cancer

NCT01247571 | Completed Phase 2 Results DMC

• 5 other identifiers: NCI-2011-02658GOG-0230DCDR0000689585U10CA180868U10CA027469
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 41

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.

Conditions

Recurrent Uterine Corpus Sarcoma; Uterine Carcinosarcoma

Outcome Measures

Primary Outcomes (3)

• 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

  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.

• 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.

  6 months

• Number of Patients With Grade 3 or Higher Adverse Events

  Grade 3 or higher adverse events were graded by CTCAE v4.

  Every cycle while on treatment

Secondary Outcomes (2)

• Progression-free Survival

  From start of treatment to time of progression or death, assessed up to 5 years

• Overall Survival

  Time from start of treatment to time of death or the date of last contact, assessed up to 5 years

Study Arms (1)

Treatment (pazopanib hydrochloride)

EXPERIMENTAL

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

Drug: Pazopanib Hydrochloride

Interventions

Pazopanib Hydrochloride DRUG

Given PO

Also known as: GW786034B, Votrient

Treatment (pazopanib hydrochloride)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead
• NRG Oncology: collaborator

Study Sites (41)

University of Colorado Cancer Center - Anschutz Cancer Pavilion

Aurora, Colorado, 80045, United States

Location

Smilow Cancer Hospital Care Center at Saint Francis

Hartford, Connecticut, 06105, United States

Location

The Hospital of Central Connecticut

New Britain, Connecticut, 06050, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Florida Hospital Orlando

Orlando, Florida, 32803, United States

Location

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

Location

Sudarshan K Sharma MD Limted-Gynecologic Oncology

Hinsdale, Illinois, 60521, United States

Location

Indiana University/Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Saint Vincent Oncology Center

Indianapolis, Indiana, 46260, United States

Location

MedStar Franklin Square Medical Center/Weinberg Cancer Institute

Baltimore, Maryland, 21237, United States

Location

Saint Joseph Mercy Hospital

Ann Arbor, Michigan, 48106-0995, United States

Location

Michigan Cancer Research Consortium CCOP

Ann Arbor, Michigan, 48106, United States

Location

Oakwood Hospital and Medical Center

Dearborn, Michigan, 48124, United States

Location

Saint John Hospital and Medical Center

Detroit, Michigan, 48236, United States

Location

Hurley Medical Center

Flint, Michigan, 48502, United States

Location

Genesys Regional Medical Center-West Flint Campus

Flint, Michigan, 48532, United States

Location

Genesys Regional Medical Center

Grand Blanc, Michigan, 48439, United States

Location

Allegiance Health

Jackson, Michigan, 49201, United States

Location

Sparrow Hospital

Lansing, Michigan, 48912, United States

Location

Saint Mary Mercy Hospital

Livonia, Michigan, 48154, United States

Location

Saint Joseph Mercy Oakland

Pontiac, Michigan, 48341, United States

Location

Saint Joseph Mercy Port Huron

Port Huron, Michigan, 48060, United States

Location

Saint Mary's of Michigan

Saginaw, Michigan, 48601, United States

Location

Saint John Macomb-Oakland Hospital

Warren, Michigan, 48093, United States

Location

Cancer Research for the Ozarks NCORP

Springfield, Missouri, 65804, United States

Location

CoxHealth South Hospital

Springfield, Missouri, 65807, United States

Location

Nebraska Methodist Hospital

Omaha, Nebraska, 68114, United States

Location

Cooper Hospital University Medical Center

Camden, New Jersey, 08103, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

Location

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, 28203, United States

Location

Novant Health Presbyterian Medical Center

Charlotte, North Carolina, 28204, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

Location

Lake University Ireland Cancer Center

Mentor, Ohio, 44060, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Oklahoma Cancer Specialists and Research Institute-Tulsa

Tulsa, Oklahoma, 74146, United States

Location

Abington Memorial Hospital

Abington, Pennsylvania, 19001, United States

Location

Women and Infants Hospital

Providence, Rhode Island, 02905, United States

Location

MeSH Terms

Interventions

pazopanib

Results Point of Contact

• Title: Linda Gedeon for William Brady, PhD.
• Organization: NRG Oncology

lgedeon@gogstats.org

716-845-1169

Study Officials

• Susana Campos

  NRG Oncology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2010
• First Posted: November 24, 2010
• Study Start: January 1, 2011
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: August 8, 2019
• Results First Posted: July 27, 2017

Record last verified: 2019-08

Locations

US (41)