Metastatic Renal Cell CarcinomaPhase 2NCT01100242
Velcade and Sorafenib in Unresected or Metastatic Renal Cell Carcinoma
A Phase 2 study testing Velcade and Sorafenib in people with Metastatic Renal Cell Carcinoma, run by New Mexico Cancer Research Alliance at 3 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Renal Cell Carcinoma
- What is being tested?
- Velcade and Sorafenib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2010to Feb 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106
The Cancer Center at Presbyterian
Albuquerque, New Mexico, 87110
Memorial Medical Center- Cancer Center
Las Cruces, New Mexico, 88011
About this study
Official title: 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
Read the detailed description
- 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.
- Conditions
- Metastatic Renal Cell Carcinoma
- Being tested
- Velcade and Sorafenib
- Keywords
- Renal Cell Carcinoma, metastatic renal cell cancer, kidney cancer
- Medical subject headings
- Carcinoma, Renal Cell, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Velcade and SorafenibDrug
Also called velcade, bortezomib, sorafenib
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Velcade and Sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 36 weeks
Secondary outcomes (2)
Overall Response Rate (ORR)
Tumor response 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:) Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. Overall response rate (ORR) is the percentage of patients who achieve a CR or PR
Measured: 42 days
Toxicity Profile
Toxicity is assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Toxicity profile is reported as the number of patients who received at least one dose of on-study treatment and experienced a grade 3 or grade 4 adverse event (AE). For a more complete listing of all AEs experienced by patients on study, please see the Adverse Event section.
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionJan 2014
- Study completionFeb 2015
Why it stopped: Low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Renal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- New Mexico Cancer Research Alliance
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Lauer, MD, Principal investigator, New Mexico Cancer Research Alliance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01100242
- Sponsor's protocol ID
- INST 0812
- Other IDs
- NCI-2011-02944
- Status last verified
- Aug 2015
- First submitted
- 6 Apr 2010
- Last updated
- 17 Sep 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 25777345
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Velcade (Bortezomib) and Sorafenib in Unresected or Metastatic Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT01100242
- Acronym / sponsor ID
- INST 0812
- Conditions
- Metastatic Renal Cell Carcinoma
- Keywords
- Renal Cell Carcinoma, metastatic renal cell cancer, kidney cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual
- Enrolment
- 17 participants (actual)
- Lead sponsor
- New Mexico Cancer Research AllianceUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Jan 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 8 Apr 2010 (estimated)
- Results
- Posted 17 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1: VELCADE and Sorafenib | Experimental | Drug: Velcade and SorafenibPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Velcade and SorafenibAlso: velcade, bortezomib, sorafenibVelcade 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) | Drug | Arm 1: VELCADE and Sorafenib |
Primary outcome
Progression Free Survival (PFS)
Time frame: 36 weeks
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.
2 secondary outcomes
Overall Response Rate (ORR)
Time frame: 42 days
Toxicity Profile
Time frame: 42 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25777345Rao 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.
- University of New Mexico Cancer CenterLink provided by the sponsor.
- New Mexico Cancer Care AllianceLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Lauer, MD principal investigator
New Mexico Cancer Research Alliance
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Velcade and Sorafenib in people with Metastatic Renal Cell Carcinoma, run by New Mexico Cancer Research Alliance at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) (time frame: 36 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01100242, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2015.