Velcade and Sorafenib in Unresected or Metastatic Renal Cell Carcinoma
This is an open label, non-randomized, single arm phase II study. The primary objective of this study is to investigate the efficacy of combination of sorafenib and VELCADE® (bortezomib). The primary efficacy endpoint is Progression-Free Survival (PFS). The secondary objectives of this study are to:
Assess the response rate of this combination in this patient population and Assess the toxicity of this combination in this patient population
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Velcade (Bortezomib) and Sorafenib in Unresected or Metastatic Renal Cell Carcinoma|
- Progression free survival of untreated or metastatic renal cell cancer patients treated with sorafenib and bortezomib [ Time Frame: 42 days ] [ Designated as safety issue: No ]
- Response rate of Velcade and Sorafenib in Unrectable or Metastatic Renal Cell Carcinoma [ Time Frame: 42 days ] [ Designated as safety issue: No ]
- Toxicity of Velcade and Sorafenib in Unresected or Metastatic Renal Cell Carcinoma [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2010|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Experimental: Arm 1
Patients will be given VELCADE® 1mg/m2 by IV ondays 1,4,8 & 11 and Sorafenib at a dosage of 200 mg PO BID. One full course is comprised of 21 days.
Drug: Velcade and Sorafenib
VELCADE® 1mg/m2 IV days 1,4,8 & 11 Sorafenib 200 mg PO BID One course is 21 days
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.
|United States, New Mexico|
|University of New Mexico Cancer Center|
|Albuquerque, New Mexico, United States, 87106|
|The Cancer Center at Presbyterian|
|Albuquerque, New Mexico, United States, 87110|
|Memorial Medical Center- Cancer Center|
|Las Cruces, New Mexico, United States, 88011|
|Principal Investigator:||Richard Lauer, MD||New Mexico Cancer Care Alliance|