Velcade and Sorafenib in Unresected or Metastatic Renal Cell Carcinoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier:
NCT01100242
First received: April 6, 2010
Last updated: February 12, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention Phase
Metastatic Renal Cell Carcinoma
Drug: Velcade and Sorafenib
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by New Mexico Cancer Care Alliance:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 17
Study Start Date: April 2010
Estimated Study Completion Date: January 2015
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Names:
  • velcade
  • bortezomib
  • sorafenib

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 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 study:

  • 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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01100242

Locations
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
Sponsors and Collaborators
New Mexico Cancer Care Alliance
Investigators
Principal Investigator: Richard Lauer, MD New Mexico Cancer Care Alliance
  More Information

Additional Information:
No publications provided

Responsible Party: New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier: NCT01100242     History of Changes
Other Study ID Numbers: INST 0812, NCI-2011-02944
Study First Received: April 6, 2010
Last Updated: February 12, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by New Mexico Cancer Care Alliance:
Renal Cell Carcinoma
metastatic renal cell cancer
kidney cancer

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Bortezomib
Sorafenib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 19, 2014