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Gemcitabine With or Without Pazopanib in Treating Patients With Refractory Soft Tissue Sarcoma

NCT01532687 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2021-09-27

Study results available
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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.

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

Interventions

DRUG

Gemcitabine

Given IV

DRUG

Gemcitabine Hydrochloride

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Pazopanib

Given PO

DRUG

Pazopanib Hydrochloride

Given PO

OTHER

Placebo Administration

Given PO

Sponsors & Collaborators

  • Novartis Pharmaceuticals

    collaborator INDUSTRY

  • Oregon Health and Science University

    collaborator OTHER

  • OHSU Knight Cancer Institute

    lead OTHER

Principal Investigators

  • Christopher W Ryan · OHSU Knight Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-13
Primary Completion
2019-10-31
Completion
2019-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01532687 on ClinicalTrials.gov