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Pazopanib Hydrochloride in Treating Patients With Advanced Angiosarcoma | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Pazopanib Hydrochloride in Treating Patients With Advanced Angiosarcoma

Phase II Study Evaluating the Role of Pazopanib in Angiosarcoma

NCT01462630•Fox Chase Cancer Center

Summary

This phase II trial studies how well pazopanib hydrochloride works in treating patients with advanced angiosarcoma. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed Description

PRIMARY OBJECTIVES: I. To determine the progression free survival (PFS) at 3 months and response rate defined as complete response (CR) and partial response (PR) in angiosarcoma patients treated with pazopanib. SECONDARY OBJECTIVES: I. To assess overall survival of patients treated with pazopanib. II. To gather more safety data for pazopanib in this patient population. III. To explore the ability of \[F-18\] fludeoxyglucose (FDG) (positron emission tomography \[PET\])/computed tomography (CT) imaging to assess response. OUTLINE: Patients receive pazopanib hydrochloride orally (PO) once daily (QD). Courses repeat every 21 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects must provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow up
•* Note: informed consent may be obtained prior to start of the specified screening window
•* Note: procedures conducted as part of the subject's routine clinical management (e.g., blood count, imaging study such as bone scan) and obtained prior to signing of informed consent may be utilized for screening or baseline purposes provided these procedures are conducted as specified in the protocol
•Histologically or cytologically proven diagnosis of advanced stage angiosarcoma that is not amenable to treatment with curative intent; specify site of origin as cutaneous vs. non-cutaneous
•Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2
•Must have measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 or cutaneous disease amenable to serial measurements should be present; a measurable lesion is defined as a lesion that can be accurately measured in at least one dimension with the longest diameter \>= 10 mm with computed tomography (CT) scan; lesions that have been treated with therapeutic intent will be considered measurable if they have increased in size by more than 20%
•Absolute neutrophil count (ANC) \>= 1.5 X 10\^9/L
•Hemoglobin \>= 9 g/dL (5.6 mmol/L)
•Platelets \>= 100 X 10\^9/L
•International normalized ratio (INR) =\< 1.2 X upper limit of normal (ULN)
+27 more criteria

Exclusion Criteria

•Prior malignancy:
•Subjects with a history of a prior malignancy other than angiosarcoma who have been disease-free for at least 2 years prior to the first dose of study drug and/or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible
•History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroids or anti-seizure medications for 3 months prior to first dose of study drug; screening with CNS imaging studies (CT or magnetic resonance imaging \[MRI\]) is required only if clinically indicated or if the subject has a history of CNS metastases
•Clinically significant gastrointestinal (GI) abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to:
•* Active peptic ulcer disease
•* Known intraluminal metastatic lesion/s with risk of bleeding
•* Inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease), or other gastrointestinal conditions with increased risk of perforation
•* History of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning study treatment
•* Clinically significant (\> 1/2 teaspoon) hemoptysis or gastrointestinal hemorrhage in the past 6 months
•Evidence of active bleeding or bleeding diathesis; recent hemoptysis (\>= 1/2 teaspoon of red blood within 8 weeks before first dose of study drug)
+28 more criteria

Locations (5)

Northwestern University

Chicago, Illinois, United States

University of Michigan

Ann Arbor, Michigan, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Hollings Cancer Center Medical University of South Carolina

Charleston, South Carolina, United States

M D Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

November 3, 2011

Primary Completion Date

January 2, 2019

Completion Date

January 12, 2021

Last Updated

August 19, 2022

Enrollment

ACTUAL participants

Conditions

Adult AngiosarcomaRecurrent Adult Soft Tissue SarcomaStage III Adult Soft Tissue SarcomaStage IV Adult Soft Tissue Sarcoma

Interventions

pazopanib hydrochloride

DRUG

laboratory biomarker analysis

OTHER

positron emission tomography

PROCEDURE

computed tomography

PROCEDURE

fludeoxyglucose F 18

RADIATION

Phase II Study of 5-Day Hypofractionated Preoperative Radiation Therapy for Soft Tissue Sarcomas: Expansion Cohort

NCT02701153

Recurrent Adult Soft Tissue Sarcoma

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 19, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Pazopanib Hydrochloride in Treating Patients With Advanced Angiosarcoma

Inclusion Criteria

Exclusion Criteria

Phase II Study of 5-Day Hypofractionated Preoperative Radiation Therapy for Soft Tissue Sarcomas: Expansion Cohort

Bevacizumab and Temsirolimus Alone or in Combination With Valproic Acid or Cetuximab in Treating Patients With Advanced or Metastatic Malignancy or Other Benign Disease

Observation, Radiation Therapy, Combination Chemotherapy, and/or Surgery in Treating Young Patients With Soft Tissue Sarcoma

AZD0530 in Treating Patients With Recurrent Locally Advanced or Metastatic Soft Tissue Sarcoma

Preoperative Thalidomide With Radiation Therapy For Patients With Low-Grade Primary Soft Tissue Sarcoma or Thalidomide With Radiation Therapy and Chemotherapy For Patients With High-Grade or Intermediate-Grade Primary Soft Tissue Sarcoma of the Arm, Leg, or Body Wall

Vinorelbine Tartrate and Cyclophosphamide in Combination With Bevacizumab or Temsirolimus in Treating Patients With Recurrent or Refractory Rhabdomyosarcoma