Selumetinib With or Without Temsirolimus in Treating Patients With Metastatic, Recurrent, or Locally Advanced Soft Tissue Sarcoma That Cannot Be Removed By Surgery

Part of paid clinical trials in Beverly Hills, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT01206140
Phase
PHASE2
Status
Completed

Conditions

  • Recurrent Adult Soft Tissue Sarcoma
  • Stage III Adult Soft Tissue Sarcoma
  • Stage IV Adult Soft Tissue Sarcoma

Eligibility Criteria

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

Interventions

  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Selumetinib — DRUG
    Given PO
  • Temsirolimus — DRUG
    Given IV

Study Details

This randomized phase II trial is studying how well giving selumetinib together with or without temsirolimus works in treating patients with metastatic, recurrent, or locally advanced soft tissue sarcoma that cannot be removed by surgery. Selumetinib and temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving selumetinib together with temsirolimus is more effective than giving selumetinib alone.

Key Dates

Start date
Oct 31, 2010
Status verified
Jan 2015
Primary completion
Apr 30, 2015
Completion
Apr 30, 2015

Study Design

Enrollment
70 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I (selumetinib and temsirolimus)
    Patients receive selumetinib PO twice daily on days 1-28 and temsirolimus IV over 30-60 minutes on days 1, 8, 15, and 22.
  • Experimental: Arm II (selumetinib)
    Patients receive selumetinib as in arm I. Patients who experience disease progression may cross over to arm I.

Primary Outcome Measure

Progression-free Survival [ Time Frame: Until disease progression or death, up to 4.5 years ]

Locations (8)

FacilityCityStateZIPSite coordinators
Tower Cancer Research FoundationBeverly HillsCalifornia90211-1850-
City of Hope Comprehensive Cancer CenterDuarteCalifornia91010-
USC / Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95817-
University of California Davis Phase 2 ConsortiumSacramentoCalifornia95817-
Penn State Milton S Hershey Medical CenterHersheyPennsylvania17033-0850-
University of PittsburghPittsburghPennsylvania15232-
University of Pittsburgh Cancer InstitutePittsburghPennsylvania15232-

Find similar trials in Beverly Hills, CA

By research site
Tower Cancer Research Foundation· Beverly Hills, CACity of Hope Comprehensive Cancer Center· Duarte, CAUSC / Norris Comprehensive Cancer Center· Los Angeles, CAUniversity of California Davis Comprehensive Cancer Center· Sacramento, CAUniversity of California Davis Phase 2 Consortium· Sacramento, CAPenn State Milton S Hershey Medical Center· Hershey, PA

Related Studies