Trebananib With or Without Bevacizumab, Pazopanib Hydrochloride, Sorafenib Tosylate, or Sunitinib Malate in Treating Patients With Advanced Kidney Cancer

Part of paid clinical trials in Duarte, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT01664182
Phase
PHASE2
Status
Completed

Conditions

  • Advanced Renal Cell Carcinoma
  • Advanced Sarcomatoid Renal Cell Carcinoma
  • Stage III Renal Cell Cancer AJCC v7
  • Stage IV Renal Cell Cancer AJCC v7

Eligibility Criteria

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

Interventions

  • Bevacizumab — BIOLOGICAL
    Given IV
  • Pazopanib Hydrochloride — DRUG
    Given PO
  • Sorafenib Tosylate — DRUG
    Given PO
  • Sunitinib Malate — DRUG
    Given PO
  • Trebananib — BIOLOGICAL
    Given IV

Study Details

This randomized phase II trial studies how well trebananib with or without bevacizumab, pazopanib hydrochloride, sorafenib tosylate, or sunitinib malate works in treating patients with kidney cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced). Trebananib may stop the growth of tumor cells by blocking blood flow to the tumor. Immunotherapy with monoclonal, such as bevacizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Pazopanib hydrochloride, sorafenib tosylate, and sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor. It is not yet known whether giving trebananib with or without bevacizumab, pazopanib hydrochloride, sorafenib tosylate, or sunitinib malate is more effective in treating kidney cancer.

Key Dates

First listed
Aug 14, 2012
Start date
Aug 1, 2012
Status verified
May 2022
Primary completion
Dec 7, 2020
Completion
Dec 7, 2020

Study Design

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

Arms

  • Experimental: Arm I (trebananib monotherapy)
    Patients receive trebananib IV over 30-60 minutes on days 1, 8, 15, 22, 29, and 36. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity.
  • Experimental: Arm II (trebananib and anti-VEGF therapy)
    Patients receive trebananib as in Arm I and either bevacizumab IV over 30-90 minutes on days 1, 15, and 29, pazopanib hydrochloride PO QD on days 1-42, sorafenib tosylate PO BID on days 1-42, or sunitinib malate PO QD on days 1-28. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Observed Response Rate [ Time Frame: Up to 8 weeks ]

Locations (12)

FacilityCityStateZIPSite coordinators
City of Hope Comprehensive Cancer CenterDuarteCalifornia91010-
USC / Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95817-
City of Hope South PasadenaSouth PasadenaCalifornia91030-
Wayne State University/Karmanos Cancer InstituteDetroitMichigan48201-
Mayo Clinic in RochesterRochesterMinnesota55905-
Metro Minnesota Community Oncology Research ConsortiumSaint Louis ParkMinnesota55416-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08903-
UNC Lineberger Comprehensive Cancer CenterChapel HillNorth Carolina27599-
Penn State Milton S Hershey Medical CenterHersheyPennsylvania17033-0850-
University of Pittsburgh Cancer Institute (UPCI)PittsburghPennsylvania15232-
VCU Massey Cancer Center at Hanover Medical ParkMechanicsvilleVirginia23116-

Find similar trials in Duarte, CA

By research site
City of Hope Comprehensive Cancer Center· Duarte, CAUSC / Norris Comprehensive Cancer Center· Los Angeles, CAUniversity of California Davis Comprehensive Cancer Center· Sacramento, CACity of Hope South Pasadena· South Pasadena, CAWayne State University/Karmanos Cancer Institute· Detroit, MIMayo Clinic in Rochester· Rochester, MN

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