Sorafenib Tosylate and Bevacizumab in Treating Patients With Advanced Kidney Cancer

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00126503
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Chromophobe Renal Cell Carcinoma
  • Clear Cell Renal Cell Carcinoma
  • Papillary Renal Cell Carcinoma
  • Recurrent Renal Cell Carcinoma
  • Sarcomatoid Renal Cell Carcinoma
  • Stage IV Renal Cell Cancer

Eligibility Criteria

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

Interventions

  • Bevacizumab — BIOLOGICAL
    Given IV
  • Sorafenib Tosylate — DRUG
    Given PO
  • Pharmacological Study — OTHER
    Correlative studies
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies

Study Details

This phase I/II trial studies the side effects and best dose of sorafenib tosylate and bevacizumab and to see how well they work in treating patients with advanced kidney cancer. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth by targeting certain cells. Bevacizumab and sorafenib tosylate may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving sorafenib tosylate together with bevacizumab may kill more tumor cells.

Key Dates

First listed
Aug 4, 2005
Start date
May 31, 2005
Status verified
Sep 2014
Primary completion
Oct 31, 2011
Completion
Feb 29, 2012

Study Design

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

Arms

  • Experimental: Treatment (bevacizumab and sorafenib tosylate)
    Phase I: Patients receive sorafenib PO twice daily on days 1-28 and bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of sorafenib and bevacizumab until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. An additional 6 patients are treated at the MTD. Phase II: Patients receive sorafenib PO once daily on days 1-28 and bevacizumab IV over 90 minutes on days 1 and 15 at the MTD in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of BAY 43-9006 (Sorafenib)in Combination With Bevacizumab (Phase I) [ Time Frame: at 28 days ]

Locations (5)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Dana-Farber Cancer InstituteBostonMassachusetts02115-
Dana-Farber Harvard Cancer CenterBostonMassachusetts02115-
University of Pennsylvania/Abramson Cancer CenterPhiladelphiaPennsylvania19104-
Vanderbilt-Ingram Cancer CenterNashvilleTennessee37232-

Find similar trials in Boston, MA

By research site
Beth Israel Deaconess Medical Center· Boston, MADana-Farber Cancer Institute· Boston, MADana-Farber Harvard Cancer Center· Boston, MAUniversity of Pennsylvania/Abramson Cancer Center· Philadelphia, PAVanderbilt-Ingram Cancer Center· Nashville, TN

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