Cabozantinib and Temozolomide for the Treatment of Unresectable or Metastatic Leiomyosarcoma or Other Soft Tissue Sarcoma

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT04200443
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Metastatic Leiomyosarcoma
  • Metastatic Soft Tissue Sarcoma
  • Stage III Uterine Corpus Leiomyosarcoma AJCC v8
  • Stage IIIA Uterine Corpus Leiomyosarcoma AJCC v8
  • Stage IIIB Uterine Corpus Leiomyosarcoma AJCC v8
  • Stage IIIC Uterine Corpus Leiomyosarcoma AJCC v8
  • Stage IV Uterine Corpus Leiomyosarcoma AJCC v8
  • Stage IVA Uterine Corpus Leiomyosarcoma AJCC v8
  • Stage IVB Uterine Corpus Leiomyosarcoma AJCC v8
  • Unresectable Leiomyosarcoma
  • Unresectable Soft Tissue Sarcoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cabozantinib — DRUG
    Given PO
  • Quality-of-Life Assessment — OTHER
    Ancillary studies
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Temozolomide — DRUG
    Given PO

Study Details

This phase II trial studies how well cabozantinib and temozolomide work in treating patients with leiomyosarcoma or other soft tissue sarcoma that cannot be removed by surgery (unresectable) or has spread to other places in the body (metastatic). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving cabozantinib and temozolomide may work better than either one alone in treating patients with leiomyosarcoma or other soft tissue sarcoma. Cabozantinib is an investigational drug, which means that it has not been approved by the United States (US) Food and Drug Administration (FDA) or any other regulatory agencies for sale or use by the public for the indication under investigation in this study.

Key Dates

Start date
Jan 14, 2020
Status verified
Apr 2026
Primary completion
Apr 4, 2025
Completion
Sep 10, 2026

Study Design

Enrollment
96 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (cabozantinib, temozolomide)
    Patients receive cabozantinib PO QD on days 1-28 and temozolomide PO QD on days 1-5. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: After the first 12 weeks of therapy ]

Locations (5)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010-
Northwestern UniversityChicagoIllinois60611-
University of Iowa/Holden Comprehensive Cancer CenterIowa CityIowa52242-
Washington University School of MedicineSt LouisMissouri63110-
Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Duarte, CA

By research site
City of Hope Medical Center· Duarte, CANorthwestern University· Chicago, ILUniversity of Iowa/Holden Comprehensive Cancer Center· Iowa City, IAWashington University School of Medicine· St Louis, MOMedical College of Wisconsin· Milwaukee, WI

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