Bevacizumab With or Without TRC105 in Treating Patients With Metastatic Kidney Cancer (NCT01727089) | Clinical Trial Compass
CompletedPhase 2
Bevacizumab With or Without TRC105 in Treating Patients With Metastatic Kidney Cancer
United States59 participantsStarted 2012-11-01
Plain-language summary
This randomized phase II trial studies how well bevacizumab with or without anti-endoglin monoclonal antibody TRC105 (TRC105) works in treating patients with kidney cancer that has spread to other parts of the body (metastatic). Monoclonal antibodies, such as bevacizumab and anti-endoglin monoclonal antibody TRC105, may block tumor growth in different ways by targeting certain cells.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patients must have histologically or cytologically confirmed renal cancer; all histologic subtypes will be eligible
* Patients must have metastatic disease which is measurable, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) to \>= 20 mm in the long axis by chest x-ray, \>= 10 mm in the long axis by spiral computed tomography (CT), magnetic resonance imaging (MRI), calipers, or clinical exam, or \>= 15 mm in the short axis for lymph nodes
* Patients must have received at least 1 prior systemic therapy for renal cancer but no more than 4 prior therapies; they must have documented intolerance to or progression despite at least 1 systemic therapy; therapy administered in the adjuvant setting counts toward the prior systemic therapy total; if adjuvant therapy is the patient's only prior therapy the disease must have recurred during treatment or within 3 months of discontinuation
* Allowable prior therapies include VEGF tyrosine kinase inhibitor (TKIs), mammalian target of rapamycin (mTOR) inhibitors, and cytokine therapy (example: interleukin-2 \[IL2\])
* At least 2 weeks must have elapsed from the last dose of the prior systemic therapy for biologics and 4 weeks for chemotherapy (6 weeks for nitrosoureas or mitomycin C); also note that at least 3 weeks should have elapsed since prior TKI administration
* Eastern Cooperative Onco…
What they're measuring
1
Progression-free Survival at 24 Weeks
Timeframe: The duration of time from start of treatment to time of progression or death, assessed at 24 weeks
2
Progression-free Survival at 12 Weeks
Timeframe: The duration of time from start of treatment to time of progression or death, assessed at 12 weeks