Pazopanib Hydrochloride in Treating Patients With Advanced Angiosarcoma

NCT01462630 | Completed Phase 2 Results DMC

• 5 other identifiers: SAR-043NCI-2011-0131411-042OER-SAR-043P30CA006927
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Adult Angiosarcoma; Recurrent Adult Soft Tissue Sarcoma; Stage III Adult Soft Tissue Sarcoma; Stage IV Adult Soft Tissue Sarcoma

Outcome Measures

Primary Outcomes (3)

• PFS Rate

  Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), 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. PFS was estimated using the method of Kaplan and Meier.

  3 months

• Response Rate Defined as CR

  Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Standard estimates of the binomial proportion will be used to estimate and place confidence bounds on the several response rates.

  3 months

• Response Rate Defined as Partial Response (PR)

  Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Partial Response: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Standard estimates of the binomial proportion will be used to estimate and place confidence bounds on the several response rates.

  3 months

Secondary Outcomes (3)

• Overall Survival of Patients Treated With Pazopanib Hydrochloride

  Up to 107 weeks

• Evaluation of Toxicity of Pazopanib Hydrochloride in This Patient Population

  Up to 2 years

• Ability of [F-18] FDG PET/CT as an Imaging Agent in Predicting Efficacy or Early Response as Compared With CT Imaging

  Up to 2 years

Study Arms (1)

Treatment (enzyme inhibitor therapy)

EXPERIMENTAL

Patients receive pazopanib hydrochloride PO QD. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Drug: pazopanib hydrochloride; Other: laboratory biomarker analysis; Procedure: positron emission tomography; Procedure: computed tomography; Radiation: fludeoxyglucose F 18

Interventions

pazopanib hydrochloride DRUG

Given PO

Also known as: GW786034B, Votrient

Treatment (enzyme inhibitor therapy)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (enzyme inhibitor therapy)

positron emission tomography PROCEDURE

Correlative studies

Also known as: FDG-PET, PET, PET scan, tomography, emission computed

Treatment (enzyme inhibitor therapy)

computed tomography PROCEDURE

Correlative studies

Also known as: tomography, computed

Treatment (enzyme inhibitor therapy)

fludeoxyglucose F 18 RADIATION

Correlative studies

Also known as: 18FDG, FDG

Treatment (enzyme inhibitor therapy)

Eligibility Criteria

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

You may qualify if:

• 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)
• Activated partial thromboplastin time (aPTT) =\< 1.2 X ULN
• Total bilirubin =\< 1.5 X ULN (may not have abnormalities in both bilirubin and transaminases)
• Alanine amino transferase (ALT) and aspartate aminotransferase (AST) =\< 2.5 X ULN (may not have abnormalities in both bilirubin and transaminases)
• Serum creatinine =\< 1.5 mg/dL (133 umol/L)
• Or, if serum creatinine \> 1.5 mg/dL: calculated creatinine clearance (ClCR) \> 50 mL/min

You may not qualify if:

• 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)
• Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including, but not limited to:
• Malabsorption syndrome
• Major resection of the stomach or small bowel
• Corrected QT interval (QTc) \> 480 msecs using Bazett's formula
• Left ventricular ejection fraction \< 50%

Sponsors & Collaborators

• Fox Chase Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (5)

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111-2497, United States

Location

Hollings Cancer Center Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Hemangiosarcoma; Sarcoma

Interventions

pazopanib; Magnetic Resonance Spectroscopy; 2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole; Fluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Deoxyglucose; Deoxy Sugars; Carbohydrates

Results Point of Contact

• Title: Protocol Development Coordinator
• Organization: Fox Chase Cancer Center

ryan.romasko@fccc.edu

215-728-4097

Study Officials

• Margaret von Mehren

  Fox Chase Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: October 27, 2011
• First Posted: October 31, 2011
• Study Start: November 3, 2011
• Primary Completion: January 2, 2019
• Study Completion: January 12, 2021
• Last Updated: August 19, 2022
• Results First Posted: August 19, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)