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Velcade (Bortezomib) and Sorafenib in Unresected or Metastatic Renal Cell Carcinoma

Phase 2
18 Years
Open (Enrolling)
Metastatic Renal Cell Carcinoma

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Trial Information

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.

Inclusion Criteria:

Each patient must meet all of the following inclusion criteria to be enrolled in the

- Voluntary written informed consent before performance of any study-related procedure
not part of normal medical care, with the understanding that consent may be withdrawn
by the subject at any time without prejudice to future medical care.

- Female subject is either post-menopausal or surgically sterilized or willing to use
an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine
device, diaphragm with spermicide, condom with spermicide, or abstinence) for the
duration of the study.

- Male subject agrees to use an acceptable method for contraception for the duration of
the study.

- All patients, 18 years or older with cytologically confirmed clear cell renal with no
prior chemotherapy are eligible.

- Patients must have a life expectancy of at least 12 weeks

- Patients must have a Zebroid performance of 0-2

- Patients should have adequate bone marrow function defined by an absolute peripheral
granulocyte count of > 1500 cells/mm3 and platelet count > 100,000/mm3 and absence of
a regular red blood cell transfusion requirement.

- Patients should have adequate hepatic function with a total bilirubin < 2 mg/dl and
SGOT or SGPT < two times the upper limit of normal, and adequate renal function as
defined by a Serum creatinine < 1.5 x the upper limit of normal.

Exclusion Criteria:

Patients meeting any of the following exclusion criteria are not to be enrolled in the

- Patients with non-measurable disease.

- Patients who are unable to take medications PO.

- Patients with resectable renal cell carcinoma

- Patients with a history of Hepatitis B, or Hepatitis C

- Patients known to be HIV positive

- Patients with poorly controlled diabetes mellitus

- Patients with poorly controlled hypertension or hypotension

- Chronic pulmonary disease and a diffusion capacity < 50 %, or an FVC or FEV1 of <50%

- Severe renal impairment (CrCL< 13 ml/min)

- Patients with known malabsorption syndromes.

- Patient has Grade 2 peripheral neuropathy within 14 days before enrollment.

- Myocardial infarction within 6 months prior to enrollment or has New York Heart
Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe
uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute
ischemia or active conduction system abnormalities. Prior to study entry, any ECG
abnormality at Screening has to be documented by the investigator as not medically

- Patient has hypersensitivity to bortezomib, boron or mannitol or sorafenib.

- Female subject is pregnant or breast-feeding. Confirmation that the subject is not
pregnant must be established by a negative serum B-human chorionic gonadotropin
(B-hCG) pregnancy test result obtained during screening. Pregnancy testing is not
required for post-menopausal or surgically sterilized women.

- Patient has received other investigational drugs with 28 days before enrollment.

- Serious medical or psychiatric illness likely to interfere with participation in this
clinical study.

- Diagnosed or treated for another malignancy within 3 years of enrollment, with the
exception of complete resection of basal cell carcinoma or squamous cell carcinoma of
the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy.

- Patients may receive no other concurrent chemotherapy or radiation therapy (XRT)
during this trial.

- Patients may not have received XRT within 4 weeks prior to the first treatment.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival of untreated or metastatic renal cell cancer patients treated with sorafenib and bortezomib

Outcome Time Frame:

42 days

Safety Issue:


Principal Investigator

Richard Lauer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

New Mexico Cancer Care Alliance


United States: Food and Drug Administration

Study ID:

INST 0812



Start Date:

April 2010

Completion Date:

December 2014

Related Keywords:

  • Metastatic Renal Cell Carcinoma
  • Renal Cell Carcinoma
  • metastatic renal cell cancer
  • kidney cancer
  • Carcinoma
  • Carcinoma, Renal Cell



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