CCI-779 and Bevacizumab in Treating Patients With Metastatic or Unresectable Kidney Cancer

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00112840
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Clear Cell Renal Cell Carcinoma
  • Recurrent Renal Cell Cancer
  • Stage IV Renal Cell Cancer

Eligibility Criteria

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

Interventions

  • CCI-779 — DRUG
    CCI-779 is taken IV on days 1, 8, 15, 22 of a 28-day cycle. Dose level is dependent on phase.
  • Bevacizumab — DRUG
    Bevacizumab is taken IV on Days 1 and 15 of a 28-day cycle. Dose Level determined by phase.

Study Details

This phase I/II trial is studying the side effects and best dose of CCI-779 and bevacizumab and to see how well they work in treating patients with metastatic or unresectable kidney cancer. Drugs used in chemotherapy, such as CCI-779, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of kidney cancer by blocking blood flow to the tumor. Giving CCI-779 together with bevacizumab may kill more tumor cells.

Key Dates

First listed
Jun 3, 2005
Start date
May 31, 2005
Status verified
Jan 2022
Primary completion
Aug 9, 2010
Completion
Sep 10, 2015

Study Design

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

Arms

  • Experimental: CCI-779 and bevacizumab
    Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV 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 CCI-779 and bevacizumab until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Phase II patients receive CCI-779 and bevacizumab as in phase I at the MTD determined in phase I. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.

Primary Outcome Measure

Dose-limiting Toxicity (DLT) (Phase I) [ Time Frame: Patients observed a minimum of 4 weeks (one full course). The maximum number of cycles observed was 16 cycles. ]

Locations (2)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55905-
University of Wisconsin Hospital and ClinicsMadisonWisconsin53792-

Find similar trials in Rochester, MN

By research site
Mayo Clinic· Rochester, MNUniversity of Wisconsin Hospital and Clinics· Madison, WI

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