Velcade (Bortezomib) and Sorafenib in Unresected or Metastatic Renal Cell Carcinoma
3.1.1 Pretreatment, a complete history and physical examination to include performance
status, weight and concurrent non-malignant disease and therapy will be done before starting
treatment. Prior surgery, chemotherapy, and radiotherapy details will be noted.
3.1.2 Prior to the initiation of treatment, laboratory studies should include a CBC with
differential cell count, platelet count, urinalysis, complete metabolic profile, magnesium
and electrocardiogram. A baseline imaging study of the tumor will be performed. Other X-rays
will be done as clinically indicated.
3.1.3 Physical examination, performance status and toxicity recording will be done before
each course of therapy.
3.1.4 During the study, patients will be followed with CBC, differential and platelet counts
on days 1, 4, 8, and 11. Chemistries will also be performed before each course within a
3 day leeway prior to treatment. Clinical schedules will be considered when scheduling
patients for treatment, specimen collection and processing, and specimen shipment.
3.1.5 Measureable and evaluable disease will be evaluated by the same imaging studies done
at baseline and every 2 courses thereafter to determine tumor response.
3.1.6 For patients on warfarin, INR testing will be performed prior to the first cycle,
weekly during the first cycle, and then prior to day one for subsequent cycles if the INR is
in an acceptable range during the first cycle. If the INR has not been in an acceptable
range during the first cycle, the INR will be monitored weekly until the value is stable on
three consecutive measurements one week apart.
3.1.7 Since Sorafenib is a competitive inhibitor of CYP3A4 patients will be assessed each
cycle for medications or changes in diet that would affect CYP3A4 b metabolism.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression free survival of untreated or metastatic renal cell cancer patients treated with sorafenib and bortezomib
Richard Lauer, MD
New Mexico Cancer Care Alliance
United States: Food and Drug Administration
|University of New Mexico Cancer Center||Albuquerque, New Mexico 87131-5636|
|Memorial Medical Center- Cancer Center||Las Cruces, New Mexico 88011|
|The Cancer Center at Presbyterian||Albuquerque, New Mexico 87110|