Velcade and Sorafenib in Unresected or Metastatic Renal Cell Carcinoma



Status:Terminated
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:April 2010
End Date:February 2015

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Velcade (Bortezomib) 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

- 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.

- 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.

- Physical examination, performance status and toxicity recording will be done before
each course of therapy.

- During the study, patients will be followed with complete blood count (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.

- Measureable and evaluable disease will be evaluated by the same imaging studies done at
baseline and every 2 courses thereafter to determine tumor response.

- For patients on warfarin, International Normalized Ration (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.

- Since Sorafenib is a competitive inhibitor of cytochrome P450 isoenzyme 3A4 (CYP3A4)
patients will be assessed each cycle for medications or changes in diet that would
affect CYP3A4 metabolism.

Inclusion Criteria:

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

- 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
Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic-pyruvic transaminase
(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
study:

- Patients with non-measurable disease.

- Patients who are unable to take medications orally.

- Patients with resectable renal cell carcinoma

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

- Patients known to be Human Immunodeficiency Virus (HIV) positive

- Patients with poorly controlled diabetes mellitus

- Patients with poorly controlled hypertension or hypotension

- Chronic pulmonary disease and a diffusion capacity < 50 %, or a forced vital capacity
(FVC) or forced expiratory volume in 1 second (FEV1) of <50%

- Severe renal impairment (Creatinine clearance [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
relevant.

- 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.
We found this trial at
3
sites
1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
(505) 272-4946
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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Albuquerque, New Mexico 87110
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Las Cruces, New Mexico 88011
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