Velcade and Sorafenib in Unresected or Metastatic Renal Cell Carcinoma

NCT01100242 | Terminated Phase 2 Results DMC

• 2 other identifiers: INST 0812NCI-2011-02944
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Metastatic Renal Cell Carcinoma

Keywords

Renal Cell Carcinoma; metastatic renal cell cancer; kidney cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  Progression free survival will be measured from the beginning of treatment until there is evidence of progressive disease or death from any cause. Progression is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI): Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

  36 weeks

Secondary Outcomes (2)

• Overall Response Rate (ORR)

  42 days

• Toxicity Profile

  42 days

Study Arms (1)

Arm 1: VELCADE and Sorafenib

EXPERIMENTAL

Patients will be given VELCADE® (bortezomib) 1mg/m2 intravenously on days 1,4,8 \& 11 and sorafenib at a dosage of 200 mg orally twice per day. One full course is comprised of 21 days.

Drug: Velcade and Sorafenib

Interventions

Velcade and Sorafenib DRUG

Velcade will be administered intravenously; sorafenib will be self-administered on an outpatient basis. At least 2 courses will be administered to each patient unless there is early progression of disease or unacceptable toxicity. Repeated courses may be given to patients who benefit from the treatment (complete or partial remission or stabilization of disease)

Also known as: velcade, bortezomib, sorafenib

Arm 1: VELCADE and Sorafenib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• New Mexico Cancer Research Alliance: lead

Study Sites (3)

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87106, United States

Location

The Cancer Center at Presbyterian

Albuquerque, New Mexico, 87110, United States

Location

Memorial Medical Center- Cancer Center

Las Cruces, New Mexico, 88011, United States

Location

Related Publications (1)

• Rao A, Lauer R. Phase II study of sorafenib and bortezomib for first-line treatment of metastatic or unresectable renal cell carcinoma. Oncologist. 2015 Apr;20(4):370-1. doi: 10.1634/theoncologist.2015-0055. Epub 2015 Mar 16.

  PMID: 25777345 DERIVED

Related Links

• University of New Mexico Cancer Center
• New Mexico Cancer Care Alliance

MeSH Terms

Conditions

Carcinoma, Renal Cell; Kidney Neoplasms

Interventions

Bortezomib; Sorafenib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenylurea Compounds; Urea; Amides; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Pyridines

Results Point of Contact

• Title: Richard Lauer, MD
• Organization: University of New Mexico

rlauer@salud.unm.edu

5052725837

Study Officials

• Richard Lauer, MD

  New Mexico Cancer Research Alliance

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2010
• First Posted: April 8, 2010
• Study Start: April 1, 2010
• Primary Completion: January 1, 2014
• Study Completion: February 1, 2015
• Last Updated: September 17, 2015
• Results First Posted: September 17, 2015

Record last verified: 2015-08

Locations

US (3)