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| Sponsor: | Cancer and Leukemia Group B |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT01198158 |
Purpose
RATIONALE: Everolimus 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 in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Everolimus and bevacizumab may also stop the growth of kidney cancer by blocking blood flow to the tumor.
PURPOSE: This randomized phase III trial is studying giving everolimus together with bevacizumab to see how well it works compared to everolimus alone in treating patients with advanced kidney cancer that progressed after first-line therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Cancer |
Biological: bevacizumab Drug: everolimus Other: placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Randomized Phase III Trial Comparing Everolimus Plus Placebo Versus Everolimus Plus Bevacizumab for Advanced Renal Cell Carcinoma Progressing After Treatment With Tyrosine Kinase Inhibitors |
| Estimated Enrollment: | 700 |
| Study Start Date: | September 2010 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Arm I
Patients receive oral everolimus once daily on days 1-28 and placebo IV over 30-90 minutes on days 1 and 15.
|
Drug: everolimus
Given orally
Other: placebo
Given IV
|
|
Experimental: Arm II
Patients receive oral everolimus once daily on days 1-28 and bevacizumab IV over 30-90 minutes on days 1 and 15.
|
Biological: bevacizumab
Given IV
Drug: everolimus
Given orally
|
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to number of risk factors (i.e., Karnofsky performance status < 80%, corrected serum calcium ≥ 10 mg/dL, and hemoglobin ≤ 13 g/dL for male patients or ≤ 11.5 g/dL for female patients) present (0 vs 1 vs 2-3) and total duration of prior VEGFR tyrosine kinase inhibitor therapy (< 12 weeks vs ≥ 12 weeks). Patients are randomized to 1 of 2 treatment arms.
In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Blood, urine, and tumor tissue samples may be collected periodically for pharmacogenomic and correlative studies.
After completion of study treatment, patients are followed up every 8 weeks until disease progression and then every 6 months thereafter.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed renal cell carcinoma
No active brain metastases
Patients with treated, stable (for ≥ 3 months) brain metastases are eligible provided that they meet the following criteria:
PATIENT CHARACTERISTICS:
No arterial thrombotic events within the past 6 months, including any of the following:
No known severe impairment of lung function, defined as dyspnea or cough ≥ grade 2 and meeting 1 of the following criteria:
No active or severe liver disease (e.g., acute or chronic hepatitis, cirrhosis)
PRIOR CONCURRENT THERAPY:
At least 2 weeks since prior radiotherapy (including palliative) and no concurrent radiotherapy
Contacts and Locations
Show 381 Study Locations| Principal Investigator: | George Philips, MD, MPH | University of Vermont |
More Information
| Responsible Party: | Monica M. Bertagnolli, Cancer and Leukemia Group B |
| ClinicalTrials.gov Identifier: | NCT01198158 History of Changes |
| Other Study ID Numbers: | CDR0000684313, CALGB-90802 |
| Study First Received: | September 8, 2010 |
| Last Updated: | February 9, 2012 |
| Health Authority: | Unspecified |
|
recurrent renal cell cancer stage IV renal cell cancer stage III renal cell cancer clear cell renal cell carcinoma |
|
Carcinoma, Renal Cell Kidney Neoplasms Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases Everolimus Sirolimus Bevacizumab |
Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Antifungal Agents Anti-Infective Agents Anti-Bacterial Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |