Clinical trial NCT01532687: Gemcitabine With or Without Pazopanib in Treating Patients With Refractory Soft Tissue Sarcoma
Official title: A Randomized, Double-Blind Phase II, Study of Gemcitabine Alone or in Combination With Pazopanib for Refractory Soft Tissue Sarcoma
Conditions: Adult Alveolar Soft Part Sarcoma
Adult Angiosarcoma
Adult Desmoplastic Small Round Cell Tumor
Adult Epithelioid Hemangioendothelioma
Adult Epithelioid Sarcoma
Adult Extraskeletal Myxoid Chondrosarcoma
Adult Extraskeletal Osteosarcoma
Adult Fibrosarcoma
Adult Leiomyosarcoma
Adult Liposarcoma
Adult Malignant Peripheral Nerve Sheath Tumor
Adult Rhabdomyosarcoma
Adult Synovial Sarcoma
Adult Undifferentiated Pleomorphic Sarcoma
Malignant Adult Hemangiopericytoma
Recurrent Adult Soft Tissue Sarcoma
Sarcoma
Stage III Adult Soft Tissue Sarcoma AJCC v7
Stage IV Adult Soft Tissue Sarcoma AJCC v7
Summary: This randomized phase II trial studies how well gemcitabine hydrochloride works with or without pazopanib hydrochloride in treating patients with refractory soft tissue sarcoma. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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 tumor cells by blocking blood flow to the tumor. It is not yet known whether gemcitabine hydrochloride is more effective with or without pazopanib hydrochloride in treating patients with soft tissue sarcoma.
Interventions:
description: Given IV
name: Gemcitabine
other_name: Difluorodeoxycytidine
dFdC
dFdCyd
type: Drug
description: Given IV
name: Gemcitabine Hydrochloride
other_name: Difluorodeoxycytidine Hydrochloride
FF 10832
FF-10832
FF10832
Gemcitabine HCI
Gemzar
LY-188011
LY188011
dFdCyd
type: Drug
description: Correlative studies
name: Laboratory Biomarker Analysis
type: Other
description: Given PO
name: Pazopanib
other_name: GW786034
type: Drug
description: Given PO
name: Pazopanib Hydrochloride
other_name: GW786034B
Votrient
type: Drug
description: Given PO
name: Placebo Administration
type: Other
Study arms:
design_group_description: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and pazopanib hydrochloride PO on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
design_group_title: Arm I (gemcitabine hydrochloride and pazopanib hydrochloride)
design_group_type: Experimental
design_group_description: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and placebo PO on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression may receive single-agent pazopanib hydrochloride PO daily. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
design_group_title: Arm II (gemcitabine hydrochloride, placebo)
design_group_type: Active Comparator
Sponsor: OHSU Knight Cancer Institute
Collaborators: Novartis Pharmaceuticals Corp.
Oregon Health & Science University
Drug name mappings:
name: 盐酸吉西他滨
lang: CN
name: Gemcitabine Hydrochloride
lang: EN
name: ゲムシタビン塩酸塩
lang: JP
name: 培唑帕尼
lang: CN
name: Pazopanib Hydrochloride
lang: EN
name: パゾパニブ塩酸塩
lang: JP