Everolimus and Bevacizumab in Advanced Non-Clear Cell Renal Cell Carcinoma (RCC)

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT01399918
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • everolimus and bevacizumab — DRUG
    Cycle length will be defined as 28 days. Treatment will include everolimus 10mg, self administered orally once daily on a continuous schedule (days 1-28), and bevacizumab 10mg/kg, administered intravenously on days 1 and 15 of each cycle. Treatment will be continued until disease progression, major toxicity, or withdrawal from the study for any reason. Dose modification will be permitted based on toxicity. Patients that come off study before 6 months before documented progression/death will be treated as events for the 6 month PFS endpoint.

Study Details

The purpose of this study is to find out what effects, good and/or bad the combination of two medications, everolimus and bevacizumab, has on kidney cancer. In this clinical trial we are now testing these medications in combination. We think that both together might work better that either drug alone. Importantly, both of these drugs together have been tested in patients with a different type of kidney cancer and patients tolerated the combination well.

Key Dates

First listed
Jul 22, 2011
Start date
Jul 31, 2011
Status verified
Dec 2020
Primary completion
Dec 28, 2020
Completion
Dec 28, 2020

Study Design

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

Arms

  • Experimental: everolimus and bevacizumab
    This is a single-institution, single-arm phase II trial of everolimus in combination with bevacizumab in patients with advanced non-clear cell RCC, who have not received prior VEGF-.or mTOR-targeted therapy. A separate cohort of patients with non-clear cell RCC with papillary features will be enrolled in order to gather information regarding the efficacy given the rarity of these entities.

Primary Outcome Measure

To Evaluate the Efficacy of Combining Everolimus and Bevacizumab in Patients With Advanced RCC of Non-clear Cell Histology [ Time Frame: 6 months ]

Locations (7)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering at Basking RidgeBasking RidgeNew Jersey07920-
Memorial Sloan Kettering Cancer Center at Basking RidgeBasking RidgeNew Jersey07939-
Memorial Sloan Kettering MonmouthMiddletownNew Jersey07748-
Memorial Sloan Kettering Cancer Center @ SuffolkCommackNew York11725-
Memorial Sloan Kettering WestchesterHarrisonNew York10604-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Memorial Sloan Kettering at Mercy Medical CenterRockville CentreNew York--

Find similar trials in Basking Ridge, NJ

By condition
Kidney cancer
By specialty
OncologyUrology
By research site
Memorial Sloan Kettering at Basking Ridge· Basking Ridge, NJMemorial Sloan Kettering Cancer Center at Basking Ridge· Basking Ridge, NJMemorial Sloan Kettering Monmouth· Middletown, NJMemorial Sloan Kettering Cancer Center @ Suffolk· Commack, NYMemorial Sloan Kettering Westchester· Harrison, NYMemorial Sloan Kettering Cancer Center· New York, NY

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