Pazopanib Hydrochloride and Topotecan Hydrochloride in Treating Patients With Metastatic Soft Tissue and Bone Sarcomas
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|ClinicalTrials.gov Identifier: NCT02357810|
Recruitment Status : Recruiting
First Posted : February 6, 2015
Last Update Posted : April 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Adult Liposarcoma Metastatic Liposarcoma Metastatic Osteosarcoma Recurrent Adult Soft Tissue Sarcoma Recurrent Liposarcoma Recurrent Osteosarcoma Stage IV Adult Soft Tissue Sarcoma||Drug: Pazopanib Hydrochloride Drug: Oral Topotecan Hydrochloride Other: Laboratory Biomarker Analysis||Phase 2|
I. To determine progression free rate at week 12 for patients with soft tissue sarcoma (STS) treated with pazopanib (pazopanib hydrochloride) plus oral topotecan (topotecan hydrochloride).
I. To determine the overall response rate for patients with STS treated with combination pazopanib and topotecan.
II. To determine the clinical benefit rate (complete response [CR] + partial response [PR] + stable disease [SD]) for patients with STS treated with combination pazopanib and topotecan.
III. To determine median progression-free rate (PFR) for patients with STS treated with combination pazopanib and topotecan.
IV. To evaluate overall survival (OS) for patients with STS treated with combination pazopanib and topotecan.
V. To assess safety and tolerability for patients treated with combination pazopanib and topotecan.
VI. To estimate the PFR for patients with osteosarcoma treated with combination pazopanib and topotecan.
VII. To estimate the PFR for patients with liposarcoma treated with combination pazopanib and topotecan.
I. To estimate the correlation of PFR and OS to levels of soluble vascular endothelial growth factor receptor 2 (sVEGFR2) and phosphatidylinositol-glycan biosynthesis class F (PIGF).
Patients receive pazopanib hydrochloride orally (PO) once daily (QD) on days 1-28 and topotecan hydrochloride PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or until discontinuation per patient preference or physician recommendation.
After completion of study treatment, patients are followed up every 6 months for 2 or 5 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||136 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Pazopanib With Oral Topotecan in Patients With Metastatic and Non-resectable Soft Tissue and Bone Sarcomas|
|Study Start Date :||February 2015|
|Estimated Primary Completion Date :||July 2019|
|Estimated Study Completion Date :||June 2020|
Experimental: Treatment (pazopanib hydrochloride, topotecan hydrochloride)
Patients receive pazopanib hydrochloride PO QD on days 1-28 and topotecan hydrochloride PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: Pazopanib Hydrochloride
Drug: Oral Topotecan Hydrochloride
Other: Laboratory Biomarker Analysis
- Time from enrollment to progression [ Time Frame: At 12 weeks ]Progression defined as changes in RECIST 1.1 defined imaging, progression in non-target lesions as defined by RECIST 1.1, unequivocal clinical deterioration, or death from any cause. Will be estimated for each histologic group (STS, osteoscaroma, and liposarcoma) using Kaplan-Meier methods.
- Overall response rate (CR + PR) per RECIST version 1.1 [ Time Frame: Up to 5 years ]Response rates will be summarized by the observed proportion of patients with response, along with a 95% confidence interval.
- Clinical benefit (CR+ PR + SD) per RECIST version 1.1 [ Time Frame: Up to 5 years ]Response rates will be summarized by the observed proportion of patients with response, along with a 95% confidence interval.
- OS [ Time Frame: Time from the first dose of the study treatment until death from any cause, assessed up to 2 years ]Will be estimated for each histologic group (STS, osteoscaroma, and liposarcoma) using Kaplan-Meier methods.
- Incidence of adverse events, assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 [ Time Frame: Up to 30 days post-treatment ]Toxicities will be tabulated and summarized by the number of patients experiencing each toxicity.
- Change in cytokine levels [ Time Frame: Baseline to 12 weeks ]Verification of results of Sleijfer et al and to determine if there is an even earlier correlation that can be detected between levels of these cytokines and PFR as well as OS which may allow us to better predict treatment response early on in therapy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02357810
|Contact: Study Coordinator||(312)firstname.lastname@example.org|
|United States, Arizona|
|Mayo Clinic in Arizona||Recruiting|
|Scottsdale, Arizona, United States, 85259|
|Contact: Kelly K. Curtis 480-301-8335 email@example.com|
|Principal Investigator: Kelly K. Curtis|
|United States, Florida|
|Mayo Clinic in Florida||Recruiting|
|Jacksonville, Florida, United States, 32224-9980|
|Contact: Steven Attia 904-953-2558 firstname.lastname@example.org|
|Principal Investigator: Steven Attia|
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Contact: Mark Agulnik 312-695-1222 email@example.com|
|Principal Investigator: Mark Agulnik|
|Northwestern University- Lake Forest Hospital||Active, not recruiting|
|Lake Forest, Illinois, United States, 60045|
|United States, Iowa|
|University of Iowa Hospitals and Clinics||Recruiting|
|Iowa City, Iowa, United States, 52242|
|Contact: Mohammed M. Milhem 319-356-2324 firstname.lastname@example.org|
|Principal Investigator: Mohammed M. Milhem|
|United States, Minnesota|
|Masonic Cancer Center, University of Minnesota||Not yet recruiting|
|Minneapolis, Minnesota, United States, 55455|
|Contact: Keith M. Skubitz 612-625-5109 email@example.com|
|Principal Investigator: Keith M. Skubitz|
|Rochester, Minnesota, United States, 55905|
|Contact: Scott H. Okuno 507-284-4849 firstname.lastname@example.org|
|Principal Investigator: Scott H. Okuno|
|United States, Missouri|
|Washington University School of Medicine||Recruiting|
|Saint Louis, Missouri, United States, 63110|
|Contact: Brian A. Van Tine 314-747-8475 email@example.com|
|Principal Investigator: Brian A. Van Tine|
|United States, Wisconsin|
|University of Wisconsin Hospital and Clinics||Not yet recruiting|
|Madison, Wisconsin, United States, 53792|
|Contact: Thomas A. McFarland 608-265-3890 Thomas.firstname.lastname@example.org|
|Principal Investigator: Thomas A. McFarland|
|Principal Investigator:||Mark Agulnik||Northwestern University|