Treatment of Refractory Metastatic Renal Cell Carcinoma With Bevacizumab and RAD001 (Everolimus)

Stopped early · Phase 2

Conditions studied: Kidney Neoplasms, Kidney (Renal Cell) Cancer

In brief

To determine the safety and efficacy of the combination of bevacizumab and everolimus (RAD001) for the treatment of metastatic renal cell cancer

Key facts

Study ID

NCT00651482

Run by

Sandy Srinivas

People needed

10

Starts

2008-08-01

Expected to finish

2012-03-01

Last updated by the study team

2017-04-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed Informed Consent Form
• Histologically confirmed metastatic RCC that is predominantly clear cell Measurable disease, as defined by RECIST
• Age ≥ 18 years
• ECOG performance status of 0 or 1
• No more than 1 prior targeted therapy (eg, sorafenib, sunitinib) (prior cytokine therapy allowed)
• No more than 2 prior systemic therapies
• Ability and capacity to comply with the study and follow-up procedures
• General Exclusion Criteria
• Inability to comply with study and/or follow-up procedures
• Life expectancy of < 12 weeks
• Inadequate organ function, as evidenced by any of the following at screening:
• Absolute neutrophil count (ANC) < 1500/uL
• Platelet count ≤ 100 x 10\^9/L
• Total bilirubin ≥ 1.5 x upper limit of normal (ULN)
• AST and/or ALT > 2.5 x ULN for patients without evidence of liver metastases, or 5 x ULN for patients with documented liver metastases
• Serum creatinine > 2.0 mg/dL
• Hemoglobin < 9 g/dL (may be transfused or receive epoetin alfa to maintain or exceed this level)
• Active infection or fever > 38.5°C within 3 days of starting treatment
• Women who are pregnant or breast feeding,
• Able to conceive and unwilling to practice an effective method of birth control.
• History of other malignancies within 5 years prior to Day 1 except for tumors with a negligible risk for metastasis or death, such as adequately controlled basal cell carcinoma, squamous-cell carcinoma of the skin, carcinoma in situ of the cervix, early-stage bladder cancer, or low-grade endometrial cancer
• Malignancies that have undergone a putative surgical cure (i.e., localized prostate cancer post-prostatectomy) within 5 years prior to Day 1 may be discussed with the Principal Investigator.
• Any other medical conditions (including mental illness or substance abuse) deemed by the clinician to be likely to interfere with a patient's ability to provide informed consent, cooperate, or participate in the study, or to interfere with the interpretation of the results.
• Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study
• Disease-Specific Exclusion Criteria

Where it is running

• Stanford University School of Medicine — Stanford, California, United States

Full record on ClinicalTrials.gov

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