Pazopanib hydrochloride followed by chemotherapy and surgery in treating patients with soft tissue sarcoma (clinicaltrials.gov) - Apr 11, 2012 - P=NA, N=25; Not yet recruiting -> Recruiting
Enrollment open • Oncology
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This study is currently recruiting participants.
Verified April 2012 by Fred Hutchinson Cancer Research Center
First Received on September 12, 2011. Last Updated on April 11, 2012 History of Changes
Sponsor: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Collaborator: National Cancer Institute (NCI)
Information provided by: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT01446809
Purpose
This randomized pilot clinical trial studies pazopanib hydrochloride followed by chemotherapy and surgery in treating patients with soft tissue sarcoma. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes that are needed for cell growth and may also stop the growth of soft tissue sarcoma by blocking blood flow to the tumor. Giving pazopanib hydrochloride and chemotherapy before surgery may make the tumor smaller and reduce the amount of tissue that needs to be removed
Condition
Adult Alveolar Soft-part Sarcoma
Adult Angiosarcoma
Adult Desmoplastic Small Round Cell Tumor
Adult Epithelioid Hemangioendothelioma
Adult Epithelioid Sarcoma
Adult Extraskeletal Chondrosarcoma
Adult Fibrosarcoma
Adult Leiomyosarcoma
Adult Liposarcoma
Adult Malignant Fibrous Histiocytoma
Adult Malignant Hemangiopericytoma
Adult Malignant Mesenchymoma
Adult Neurofibrosarcoma
Adult Synovial Sarcoma
Dermatofibrosarcoma Protuberans
Stage II Adult Soft Tissue Sarcoma
Stage III Adult Soft Tissue Sarcoma
Stage IV Adult Soft Tissue Sarcoma
Intervention
Drug: pazopanib hydrochloride
Drug: doxorubicin hydrochloride
Drug: ifosfamide
Other: placebo
Procedure: therapeutic conventional surgery
Radiation: external beam radiation therapy
Other: pharmacological study
Other: laboratory biomarker analysis
Study Type:Interventional
Study Design:Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title:The Effect of Antiangiogenic Therapy With Pazopanib Prior to Preoperative Chemotherapy for Subjects With Extremity Soft Tissue Sarcomas: A Randomized Study to Evaluate Response by Imaging
Resource links provided by NLM:
Genetics Home Reference related topics: dermatofibrosarcoma protuberans
MedlinePlus related topics: Cancer Soft Tissue Sarcoma
Drug Information available for: Ifosfamide Doxorubicin Doxorubicin hydrochloride Pazopanib Pazopanib Hydrochloride U.S. FDA Resources
Further study details as provided by Fred Hutchinson Cancer Research Center:
Primary Outcome Measures:
Absolute values and changes in maximum SUV of tumors measured by FDG-PET pre- and post receipt of pazopanib versus placebo, and post receipt of 2 courses of preoperative chemotherapy [ Time Frame: At baseline and 14 days ] [ Designated as safety issue: No ]
Comparison will likely be conducted using a two-sided Wilcoxon rank sum test, often used as a nonparametric alternative to the two-sample t-test for studies with a small sample size.
Tumor response by RECIST criteria [ Time Frame: At baseline and 14 days ] [ Designated as safety issue: No ]
RECIST measurements will be performed on serial MRIs to evaluate the correlation with FDG-PET. The longest diameter (LD) of the target lesions will be measured and reported as the baseline LD. The baseline LD will be used as reference to further characterize the objective tumor response of the measurable dimension of the disease.
Pharmacokinetic analysis [ Time Frame: At 14 days after treatment with pazopanib hydrochloride ] [ Designated as safety issue: No ]
A blood sample will be drawn to assess the trough plasma pazopanib concentration. This trough level will be correlated with the change in SUV from FDG PET and with the change in RECIST measurements on MRIs.
Secondary Outcome Measures:
Safety profile of sequential treatment with pazopanib and pre-operative chemotherapy with doxorubicin and ifosfamide;the number and percent of subjects reporting adverse events (all, severe or worse, serious and related) will be quantified [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
Pathologic response at the time of surgery as measured by % tumor viability [ Time Frame: An expected average of 12 weeks ] [ Designated as safety issue: No ]
Progression free survival [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
Overall survival [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
Change in plasma and tumor angiogenic biomarker levels pre- and post neoadjuvant therapy [ Time Frame: At baseline and after 14 days ] [ Designated as safety issue: No ]
Estimated Enrollment:25
Study Start Date:April 2012
Estimated Primary Completion Date:October 2014 (Final data collection date for primary outcome measure)
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