Stage II Renal Cell CancerNCT01769885
Tivozanib Before Surgery in Treating Patients With Localized Kidney Cancer
A study testing tivozanib and therapeutic conventional surgery in people with Stage II Renal Cell Cancer and Stage III Renal Cell Cancer, run by Roswell Park Cancer Institute.
Trial summary
This clinical trial studies tivozanib before surgery in treating patients with localized kidney cancer. Tivozanib may stop the growth of tumor cells by blocking some of the growth factors needed for cell growth. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage II Renal Cell Cancer, Stage III Renal Cell Cancer
- What is being tested?
- tivozanib and therapeutic conventional surgery
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 14 Mar 2013to 2 Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Biopsy proven non-metastatic clear cell RCC, as per radiographic studies is T2 - T3a based on the American Joint Committee on Cancer (AJCC) 6th edition criteria
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
- Hemoglobin >= 10 gm/dL
- Absolute neutrophil count (ANC) >= 1.5 X 10^9/L
- Platelets >= 100 X 10^9/L
- Total bilirubin < 1.5 X upper limit of normal (ULN)
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- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 X ULN
- International normalization ratio (INR) < 1.5
- Activated partial thromboplastin time (aPTT) < 1.2 X ULN
- Serum creatinine < 1.5 mg/dL or if >= 1.5 mg/dL: calculated creatinine clearance (CrCL) > 30 mL/min based on Cockroft-Gault formula
- Must have the ability to swallow and retain oral medication
- Patients of childbearing potential must agree to use acceptable contraceptive methods (e.g., double barrier) during treatment
- Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Who cannot join
- Pregnant or nursing female patients
- Unwilling or unable to follow protocol requirements
- Any condition which in the Investigator's opinion deems the patient an unsuitable candidate to receive tivozanib (solitary kidney, multiple tumors in the same or contralateral kidney)
- Not a candidate for surgery
- Received an investigational agent within 30 days prior to enrollment
- Non-clear cell or sarcomatoid histology
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- Patients with metastatic disease at presentation
- Prior therapy with tyrosine kinase inhibitor for RCC
- A second primary malignancy (except squamous and basal cell carcinoma of skin) in the past 3 years
- Active or chronic infections
- Significant cardiovascular disease, including:
- Clinically symptomatic left ventricular failure
- Uncontrolled hypertension: systolic blood pressure of > 150 mmHg or diastolic blood pressure of > 100 mmHg documented on 2 consecutive measurements taken at least 24 hours apart
- Myocardial infarction, severe angina, or unstable angina within 6 months prior to administration of first dose of tivozanib
- History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation)
- Cardiac arrhythmias requiring anti-arrhythmic medications (except for atrial fibrillation that is well controlled with anti-arrhythmic medication)
- Coronary or peripheral artery bypass graft within 6 months of screening
- History of coronary artery disease or peripheral arterial disease
- History of stroke or carotid endarterectomy
- Patients who are taking cytochrome P450 system (CYP)3A4 inducers are excluded; patients taking CYP3A4 inducers that can be safely replaced with another agent may be enrolled after a 5 day washout period
About this study
Official title: A Pilot Clinical Trial of Neoadjuvant Tivozanib in Localized Renal Cell Carcinoma
This clinical trial studies tivozanib before surgery in treating patients with localized kidney cancer. Tivozanib may stop the growth of tumor cells by blocking some of the growth factors needed for cell growth.
Read the detailed description
PRIMARY OBJECTIVES:
- To assess the feasibility of conducting a trial of tivozanib in the neoadjuvant setting of localized (completely resectable) renal cell cancer (RCC).
SECONDARY OBJECTIVES:
- To evaluate the safety of tivozanib in the neoadjuvant setting. II. To compare the tissue before and after tivozanib for pharmacodynamic purposes (tumor infiltrating lymphocytes, myeloid derived suppressor cells, necrosis in the primary tumor after exposure to tivozanib).
III. To assess the overall response rate of tivozanib in primary tumors and correlate the radiographic changes, if any, to histo-pathological changes in the pathology specimen post-nephrectomy.
IV. To compare the various growth factors (vascular endothelial growth factor [VEGF], interleukin-8 [IL-8], placenta growth factor [P1GF]) at baseline and post treatment.
- To assess the nephrectomy rate after applying neoadjuvant tivozanib in this primarily resectable RCC population.
OUTLINE:
Patients receive tivozanib orally (PO) once daily (QD) on days 1-21. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. 25 days after completion of tivozanib, patients undergo curative nephrectomy.
After completion of study treatment, patients are followed up at 30 days.
- Being tested
- tivozanib, therapeutic conventional surgery
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tivozanibDrug
Also called AV-951, oral VEGF receptor tyrosine kinase inhibitor AV-951
Given PO
therapeutic conventional surgeryProcedure or surgery
Undergo nephrectomy
| Study group | Role | What they receive |
|---|---|---|
| Treatment (tivozanib and surgery) | Experimental | Patients receive tivozanib PO QD on days 1-21. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. 25 days after completion of tivozanib, patients undergo curative nephrectomy. Receives: Drug: tivozanib; Procedure: therapeutic conventional surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of conducting a trial of tivozanib in terms of patients completing 2 courses of tivozanib
Measured: Up to 30 days after surgery
Secondary outcomes (2)
Short-term efficacy defined as a composite of presence of partial response/stable disease/complete response assessed radiographically and correlated with the nephrectomy specimen per the Response Evaluation Criteria in Solid Tumors (RECIST) criteria
Response rate will be examined using the sample proportion and corresponding 95% confidence interval.
Measured: Up to 30 days after surgery
Incidence of adverse events evaluated using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Measured: Up to 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2013 (estimated)
- Study start14 Mar 2013
- Primary completion14 Jun 2013
- Study completion2 Dec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage II Renal Cell CancerStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- AVEO Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Saby George, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01769885
- Sponsor's protocol ID
- I 220412
- Other IDs
- NCI-2012-03185
- Status last verified
- Aug 2022
- First submitted
- 15 Jan 2013
- Last updated
- 15 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Clinical Trial of Neoadjuvant Tivozanib in Localized Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT01769885
- Acronym / sponsor ID
- I 220412
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Collaborators
- AVEO Pharmaceuticals, Inc.
- Study start
- 14 Mar 2013 (actual)
- Primary completion
- 14 Jun 2013 (actual)
- Study completion
- 2 Dec 2013 (actual)
- First posted
- 17 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial studies tivozanib before surgery in treating patients with localized kidney cancer. Tivozanib may stop the growth of tumor cells by blocking some of the growth factors needed for cell growth.
Detailed description
PRIMARY OBJECTIVES:
- To assess the feasibility of conducting a trial of tivozanib in the neoadjuvant setting of localized (completely resectable) renal cell cancer (RCC).
SECONDARY OBJECTIVES:
- To evaluate the safety of tivozanib in the neoadjuvant setting. II. To compare the tissue before and after tivozanib for pharmacodynamic purposes (tumor infiltrating lymphocytes, myeloid derived suppressor cells, necrosis in the primary tumor after exposure to tivozanib).
III. To assess the overall response rate of tivozanib in primary tumors and correlate the radiographic changes, if any, to histo-pathological changes in the pathology specimen post-nephrectomy.
IV. To compare the various growth factors (vascular endothelial growth factor [VEGF], interleukin-8 [IL-8], placenta growth factor [P1GF]) at baseline and post treatment.
- To assess the nephrectomy rate after applying neoadjuvant tivozanib in this primarily resectable RCC population.
OUTLINE:
Patients receive tivozanib orally (PO) once daily (QD) on days 1-21. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. 25 days after completion of tivozanib, patients undergo curative nephrectomy.
After completion of study treatment, patients are followed up at 30 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (tivozanib and surgery) | Experimental | Drug: tivozanib, Procedure: therapeutic conventional surgeryPatients receive tivozanib PO QD on days 1-21. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. 25 days after completion of tivozanib, patients undergo curative nephrectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Biopsy proven non-metastatic clear cell RCC, as per radiographic studies is T2 - T3a based on the American Joint Committee on Cancer (AJCC) 6th edition criteria
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
- Hemoglobin >= 10 gm/dL
- Absolute neutrophil count (ANC) >= 1.5 X 10^9/L
- Platelets >= 100 X 10^9/L
Key exclusion criteria (20 listed)
- Pregnant or nursing female patients
- Unwilling or unable to follow protocol requirements
- Any condition which in the Investigator's opinion deems the patient an unsuitable candidate to receive tivozanib (solitary kidney, multiple tumors in the same or contralateral kidney)
- Not a candidate for surgery
- Received an investigational agent within 30 days prior to enrollment
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 |
|---|---|---|
| tivozanibAlso: AV-951, oral VEGF receptor tyrosine kinase inhibitor AV-951Given PO | Drug | Treatment (tivozanib and surgery) |
| therapeutic conventional surgeryUndergo nephrectomy | Procedure or surgery | Treatment (tivozanib and surgery) |
Primary outcome
Feasibility of conducting a trial of tivozanib in terms of patients completing 2 courses of tivozanib
Time frame: Up to 30 days after surgery
2 secondary outcomes
Short-term efficacy defined as a composite of presence of partial response/stable disease/complete response assessed radiographically and correlated with the nephrectomy specimen per the Response Evaluation Criteria in Solid Tumors (RECIST) criteria
Time frame: Up to 30 days after surgery
Incidence of adverse events evaluated using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Time frame: Up to 30 days after surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2022.
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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.
Saby George principal investigator
Roswell Park Cancer Institute
Questions about this trial
What is this clinical trial studying?
A study testing tivozanib and therapeutic conventional surgery in people with Stage II Renal Cell Cancer and Stage III Renal Cell Cancer, run by Roswell Park Cancer Institute.
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 13 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: withdrawn, as of the sponsor's last update on 15 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Feasibility of conducting a trial of tivozanib in terms of patients completing 2 courses of tivozanib (time frame: Up to 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Aug 2022.