Clear Cell Renal Cell CarcinomaNCT02307474
A Pilot Study of SBRT With Adjuvant Pazopanib for Renal Cell Cancer
A study testing Stereotactic Radiosurgery and Pazopanib Hydrochloride in people with Clear Cell Renal Cell Carcinoma and Renal Cell Carcinoma, run by Case Comprehensive Cancer Center at 2 sites in United States.
Trial summary
This pilot clinical trial studies the side effects of stereotactic body radiation therapy and pazopanib hydrochloride in treating patients with kidney cancer who are not able to undergo surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clear Cell Renal Cell Carcinoma, Renal Cell Carcinoma
- What is being tested?
- Stereotactic Radiosurgery and Pazopanib Hydrochloride
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2015to Sep 2015
- 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
- Patient is considered a poor surgical candidate for removal of a renal mass as determined by pre-operative assessment due to the following factors or various combinations thereof:
- Significant comorbidity precluding ability to deliver anesthesia, without compromised ability to undergo systemic chemotherapy with pazopanib as deemed by the Urologist and Medical Oncologist
- Medically documented contraindication for surgery due to religion or risk of blood transfusion
- Size or location of tumor deemed high risk for surgical intervention by Urologist
- Unacceptable risk for anesthesia, such as history of malignant hyperthermia
- Any one of these factors may or may not constitute unresectability, but for consideration for this trial, the surgical and medical oncologist must agree that the particular constellation of findings for the patient under consideration would likely entail a low probability (< 50%) that the tumor would be resectable (with negative margins) or that the potential morbidity associated with an attempt at surgical resection would not be clinically acceptable
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- The numerical thresholds noted above are only a guideline and the clinical judgment of the surgeon and medical oncologist will determine unresectability or if patient refuses surgery or other forms of local therapy; the histopathology for this cohort is limited to clear cell carcinoma of the kidney
- Patient is able to give and sign study specific informed consent
- Negative serum or urine pregnancy test within 72 hours prior to registration for women of childbearing potential and agrees to use contraception for the duration of the treatment cycle and for a minimum of 30-days following the end of therapy (a minimum estimate 95 days)
- Patient has a pathologically confirmed diagnosis of clear cell RCC
- Karnofsky status of ≥ 70%
- Subject has no contraindication for computed tomography (CT) and/or magnetic resonance imaging (MRI) during screening and is able to complete a screening examination; CT and/or MRI within 6 months of screening is required
- Patient has inadequate organ function as defined by:
- Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT]) =< 2.5 x laboratory upper limit of normal (ULN)
- Total serum bilirubin < 1.5 x ULN
- Absolute neutrophil count (ANC) > 1500/uL
- Platelets > 100,000/uL
- Hemoglobin > 9.0 g/dL (no transfusion permitted within 1 week)
- Serum creatinine < 2.5 mg/dL
- Urine to protein to creatinine (UPC) ratio < 1; if UPC > 1, then a 24-hour urine protein must be assessed; subjects must have a 24-hour urine protein value < 1 g to be eligible
- Prothrombin time (PT) or international normalized ratio (INR) and partial thromboplastin time (PTT) < 1.2 X upper limit of normal (ULN)
Who cannot join
- Any patient with active connective tissue disease such as lupus, dermatomyositis
- Major psychiatric illness, which would prevent completion of treatment or interfere with follow-up
- Prior dose of radiation overlapping the treatment field determined by a study Radiation Oncologist to represent unacceptable risk for additional radiation to be targeted to the field
- Pregnant and lactating females, and unwillingness to use contraception; or male subject not willing to use contraception during and for 21 days after the last dose of pazopanib therapy
- Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding (e.g. active peptic ulcer, ulcerative colitis, Crohn's disease, abdominal fistula) within prior 6 months
- Clinically significant gastrointestinal abnormalities that may affect absorption (e.g. malabsorption syndrome, major resection of the stomach or small bowel)
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- Corrected QT interval (QTc) > 480 msecs (record QTc correction method)
- History of clinically significant cardiovascular condition with the past 6 months (e.g. angioplasty or stenting, myocardial infarction, unstable angina, bypass surgery, symptomatic peripheral arterial disease [PAD], class III or IV congestive heart failure)
- History of cerebrovascular accident within the past 6 months (e.g. transient ischemic attack [TIA])
- Poorly controlled hypertension (systolic blood pressure [SBP] >= 140 mmHg or diastolic blood pressure [DBP] >= 90 mmHg); the initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry
- Major surgery or trauma within 29 days prior to first dose of study drug and/or presence of any non-healing wound, fracture or ulcer (catheter placement is not major surgery)
- Evidence of active bleeding or bleeding diathesis
- Recent hemoptysis (>= half teaspoon of red blood within 8 weeks before first dose of study drug)
- Treatment with any other anti-cancer therapies (e.g. other radiation, surgery or tumor embolization) within the last 14 days prior to first dose of study drug; or chemotherapy, immunotherapy, biologic therapy, investigational or hormonal therapy within 14-days (or 5 half-lives of a drug whichever is longer) prior to the first dose of the study drug pazopanib
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
About this study
Official title: CASE 10813: A Pilot Study of SBRT With Adjuvant Pazopanib for Renal Cell Carcinoma
This pilot clinical trial studies the side effects of stereotactic body radiation therapy and pazopanib hydrochloride in treating patients with kidney cancer who are not able to undergo surgery. Stereotactic body radiation therapy is a specialized radiation therapy that delivers high doses of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue. Pazopanib hydrochloride may stop the growth of tumor cells by blocking an enzyme needed for cell growth. Giving pazopanib hydrochloride before stereotactic body radiation therapy may help make the tumor smaller and be an alternative treatment for patients who cannot undergo surgery.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the rate of treatment related toxicity reports following stereotactic body radiation therapy (SBRT) and pazopanib (pazopanib hydrochloride) as a determination of the tolerability of combined therapy in patients with clear cell renal cell carcinoma (RCC).
SECONDARY OBJECTIVES:
- To determine the tumor diameter/volume change prior to and following pazopanib treatment prior to SBRT.
II. To determine the impact of pre SBRT pazopanib therapy on radiation therapy target volumes for evidence of tumor shrinkage.
III. To evaluate tumor change in radiation therapy target volumes and the incidence of treatment related toxicity reports and sparing of non-involved nephron.
IV. Report change in tumor control following pazopanib and SBRT as evaluated by post treatment repeat biopsy and/or Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
OUTLINE:
Patients receive pazopanib hydrochloride orally (PO) daily for up to 60 days. Patients then continue to receive pazopanib hydrochloride PO daily and undergo SBRT every other day over days 60-65.
After completion of study treatment, patients are followed up at 1, 3, 6, 12, 18, and 24 months.
- Being tested
- Stereotactic Radiosurgery, Pazopanib Hydrochloride
- Keywords
- Kidney, Renal Cell Carcinoma, Cancer, Pilot, Pazopanib, stereotactic body radiation therapy, SBRT
- Medical subject headings
- Carcinoma, Renal Cell, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic RadiosurgeryRadiation
Also called SBRT, Stereotactic External Beam Irradiation, Stereotactic Radiation Therapy, Stereotactic Radiotherapy
3 fractions of 16 Gy per fraction to a total dose of 48 Gy on non-consecutive day within a 10 day time span
Pazopanib HydrochlorideDrug
Also called GW786034B, Votrient, pazopanib
Given PO starting at 800mg to be systematically altered following drug related toxicities.
| Study group | Role | What they receive |
|---|---|---|
| Treatment (Stereotactic Radiosurgery, pazopanib hydrochloride) | Experimental | Patients receive pazopanib hydrochloride PO daily for up to 60 days. Patients then continue to receive pazopanib hydrochloride PO daily and undergo stereotactic radiosurgery (SBRT) every other day over days 60-65. Receives: Radiation: Stereotactic Radiosurgery; Drug: Pazopanib Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of grade 3 and above National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 toxicity attributed to combination treatment
The toxicity profiles will be tabulated by follow-up period (i.e. 30 days and 180 days).
Measured: Up to 180 days post-SBRT
Secondary outcomes (8)
Response rate, assessed using RECIST
Estimated based on the number of responses using a binomial distribution and its confidence intervals will be estimated using Wilson's method. Factors including patient characteristics that predict response will be identified by logistic regression.
Measured: Up to 24 months
Change in tumor volume
Summarized by mean ± standard deviation and the difference between two time points (pre and post treatment) will be examined using paired T-test.
Measured: Baseline to up to 24 months
Disease-free survival
Summarized by calculating Kaplan-Meier curves. Survival rates estimated from the Kaplan-Meier curves will be estimated with 95% confidence intervals.
Measured: From the start of treatment to the date of disease progression or the date of death, whichever comes first, assessed up to 24 months
Overall survival
Summarized by calculating Kaplan-Meier curves. Survival rates estimated from the Kaplan-Meier curves will be estimated with 95% confidence intervals.
Measured: From the start of treatment to the date of death, assessed up to 24 months
Time to local progression
Summarized by calculating Kaplan-Meier curves. Survival rates estimated from the Kaplan-Meier curves will be estimated with 95% confidence intervals.
Measured: From the start of treatment to the date of local progression, assessed up to 24 months
Time to distant failure
Summarized by calculating Kaplan-Meier curves. Survival rates estimated from the Kaplan-Meier curves will be estimated with 95% confidence intervals.
Measured: From the start of treatment to the date of distant metastases, assessed up to 24 months
Rate of acute side effects
Summarized as a proportion with 95% confidence intervals.
Measured: Up to 180 days after treatment
Rate of late side effects
Summarized as a proportion with 95% confidence intervals.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2014 (estimated)
- Study startSep 2015
- Primary completionSep 2015
- Study completionSep 2015
Why it stopped: Funding Unavailable
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clear Cell Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe 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
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Rodney Ellis, Principal investigator, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02307474
- Sponsor's protocol ID
- CASE10813
- Other IDs
- NCI-2014-02275, CASE10813, P30CA043703
- Status last verified
- Mar 2016
- First submitted
- 2 Dec 2014
- Last updated
- 3 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CASE 10813: A Pilot Study of SBRT With Adjuvant Pazopanib for Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT02307474
- Acronym / sponsor ID
- CASE10813
- Keywords
- Kidney, Renal Cell Carcinoma, Cancer, Pilot, Pazopanib, stereotactic body radiation therapy, SBRT
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding Unavailable
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 4 Dec 2014 (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 pilot clinical trial studies the side effects of stereotactic body radiation therapy and pazopanib hydrochloride in treating patients with kidney cancer who are not able to undergo surgery. Stereotactic body radiation therapy is a specialized radiation therapy that delivers high doses of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue. Pazopanib hydrochloride may stop the growth of tumor cells by blocking an enzyme needed for cell growth. Giving pazopanib hydrochloride before stereotactic body radiation therapy may help make the tumor smaller and be an alternative treatment for patients who cannot undergo surgery.
Detailed description
PRIMARY OBJECTIVES:
- To determine the rate of treatment related toxicity reports following stereotactic body radiation therapy (SBRT) and pazopanib (pazopanib hydrochloride) as a determination of the tolerability of combined therapy in patients with clear cell renal cell carcinoma (RCC).
SECONDARY OBJECTIVES:
- To determine the tumor diameter/volume change prior to and following pazopanib treatment prior to SBRT.
II. To determine the impact of pre SBRT pazopanib therapy on radiation therapy target volumes for evidence of tumor shrinkage.
III. To evaluate tumor change in radiation therapy target volumes and the incidence of treatment related toxicity reports and sparing of non-involved nephron.
IV. Report change in tumor control following pazopanib and SBRT as evaluated by post treatment repeat biopsy and/or Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
OUTLINE:
Patients receive pazopanib hydrochloride orally (PO) daily for up to 60 days. Patients then continue to receive pazopanib hydrochloride PO daily and undergo SBRT every other day over days 60-65.
After completion of study treatment, patients are followed up at 1, 3, 6, 12, 18, and 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (Stereotactic Radiosurgery, pazopanib hydrochloride) | Experimental | Radiation: Stereotactic Radiosurgery, Drug: Pazopanib HydrochloridePatients receive pazopanib hydrochloride PO daily for up to 60 days. Patients then continue to receive pazopanib hydrochloride PO daily and undergo stereotactic radiosurgery (SBRT) every other day over days 60-65. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Patient is considered a poor surgical candidate for removal of a renal mass as determined by pre-operative assessment due to the following factors or various combinations thereof:
- Patient is able to give and sign study specific informed consent
- Negative serum or urine pregnancy test within 72 hours prior to registration for women of childbearing potential and agrees to use contraception for the duration of the treatment cycle and for a minimum of 30-days following the end of therapy (a minimum estimate 95 days)
- Patient has a pathologically confirmed diagnosis of clear cell RCC
- Karnofsky status of ≥ 70%
Key exclusion criteria (14 listed)
- Any patient with active connective tissue disease such as lupus, dermatomyositis
- Major psychiatric illness, which would prevent completion of treatment or interfere with follow-up
- Prior dose of radiation overlapping the treatment field determined by a study Radiation Oncologist to represent unacceptable risk for additional radiation to be targeted to the field
- Pregnant and lactating females, and unwillingness to use contraception; or male subject not willing to use contraception during and for 21 days after the last dose of pazopanib therapy
- Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding (e.g. active peptic ulcer, ulcerative colitis, Crohn's disease, abdominal fistula) within prior 6 months
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 |
|---|---|---|
| Stereotactic RadiosurgeryAlso: SBRT, Stereotactic External Beam Irradiation, Stereotactic Radiation Therapy, Stereotactic Radiotherapy3 fractions of 16 Gy per fraction to a total dose of 48 Gy on non-consecutive day within a 10 day time span | Radiation | Treatment (Stereotactic Radiosurgery, pazopanib hydrochloride) |
| Pazopanib HydrochlorideAlso: GW786034B, Votrient, pazopanibGiven PO starting at 800mg to be systematically altered following drug related toxicities. | Drug | Treatment (Stereotactic Radiosurgery, pazopanib hydrochloride) |
Primary outcome
Incidence of grade 3 and above National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 toxicity attributed to combination treatment
Time frame: Up to 180 days post-SBRT
The toxicity profiles will be tabulated by follow-up period (i.e. 30 days and 180 days).
8 secondary outcomes
Response rate, assessed using RECIST
Time frame: Up to 24 months
Change in tumor volume
Time frame: Baseline to up to 24 months
Disease-free survival
Time frame: From the start of treatment to the date of disease progression or the date of death, whichever comes first, assessed up to 24 months
Overall survival
Time frame: From the start of treatment to the date of death, assessed up to 24 months
Time to local progression
Time frame: From the start of treatment to the date of local progression, assessed up to 24 months
Time to distant failure
Time frame: From the start of treatment to the date of distant metastases, assessed up to 24 months
Rate of acute side effects
Time frame: Up to 180 days after treatment
Rate of late side effects
Time frame: Up to 24 months
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 3 Mar 2016.
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Pucotenlimab, Lenvatinib, and SBRT Before Surgery for Localized Clear Cell Renal Cell Carcinoma
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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.
Rodney Ellis principal investigator
Case Comprehensive Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic Radiosurgery and Pazopanib Hydrochloride in people with Clear Cell Renal Cell Carcinoma and Renal Cell Carcinoma, run by Case Comprehensive Cancer Center at 2 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 21 inclusion and 14 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 3 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
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?
Incidence of grade 3 and above National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 toxicity attributed to combination treatment (time frame: Up to 180 days post-SBRT). 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 3 Mar 2016.