Recruitment

Recruitment Status
Completed
Estimated Enrollment
80

Summary

Conditions
  • Adult Alveolar Soft Part Sarcoma
  • Adult Angiosarcoma
  • Stage IV Adult Soft Tissue Sarcoma AJCC v7
  • Adult Desmoplastic Small Round Cell Tumor
  • Adult Rhabdomyosarcoma
  • Adult Undifferentiated Pleomorphic Sarcoma
  • Adult Epithelioid Hemangioendothelioma
  • Adult Synovial Sarcoma
  • Adult Epithelioid Sarcoma
  • Adult Extraskeletal Myxoid Chondrosarcoma
  • Malignant Adult Hemangiopericytoma
  • Sarcoma
  • Adult Extraskeletal Osteosarcoma
  • Adult Fibrosarcoma
  • Adult Leiomyosarcoma
  • Adult Liposarcoma
  • Stage III Adult Soft Tissue Sarcoma AJCC v7
  • Adult Malignant Peripheral Nerve Sheath Tumor
  • Recurrent Adult Soft Tissue Sarcoma
Type
Interventional
Phase
Phase 2
Design
Allocation: RandomizedIntervention Model: Crossover AssignmentMasking: Double (Participant, Investigator)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

PRIMARY OBJECTIVES: I. To investigate whether treatment with gemcitabine (gemcitabine hydrochloride) plus pazopanib (pazopanib hydrochloride) improves the median progression-free survival (PFS) of patients with metastatic soft tissue sarcoma when compared to gemcitabine plus placebo. SECONDARY OBJEC...

PRIMARY OBJECTIVES: I. To investigate whether treatment with gemcitabine (gemcitabine hydrochloride) plus pazopanib (pazopanib hydrochloride) improves the median progression-free survival (PFS) of patients with metastatic soft tissue sarcoma when compared to gemcitabine plus placebo. SECONDARY OBJECTIVES: I. To assess overall response in this population to gemcitabine plus pazopanib compared to gemcitabine plus placebo. II. To assess overall survival (OS) in this population to gemcitabine plus pazopanib compared to gemcitabine plus placebo. III. To investigate differences in treatment response in different histologic subgroups (liposarcoma vs. all other eligible soft tissue sarcoma subtypes). IV. To evaluate the safety and tolerability of the combination of gemcitabine plus pazopanib. V. To assess the progression-free survival and overall response in patients treated with single agent pazopanib following administration of gemcitabine in the cross-over portion of this study. VI. To collect specimens for an exploratory analysis of potential biomarkers that predict response in patients receiving combination therapy with gemcitabine plus pazopanib. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1 and 8 and pazopanib hydrochloride orally (PO) on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM II: 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. After the completion of study treatment, patients are followed up every 3 months.

Tracking Information

NCT #
NCT01532687
Collaborators
  • Novartis Pharmaceuticals
  • Oregon Health and Science University
Investigators
Principal Investigator: Christopher W Ryan OHSU Knight Cancer Institute