A Pilot Study of SBRT With Adjuvant Pazopanib for Renal Cell Cancer

NCT02307474 | Withdrawn

• 3 other identifiers: CASE10813NCI-2014-02275P30CA043703
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Clear Cell Renal Cell Carcinoma; Renal Cell Carcinoma

Keywords

Kidney; Renal Cell Carcinoma; Cancer; Pilot; Pazopanib; stereotactic body radiation therapy; SBRT

Outcome Measures

Primary Outcomes (1)

• 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).

  Up to 180 days post-SBRT

Secondary Outcomes (8)

• Response rate, assessed using RECIST

  Up to 24 months

• Change in tumor volume

  Baseline to up to 24 months

• Disease-free survival

  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

  From the start of treatment to the date of death, assessed up to 24 months

• Time to local progression

  From the start of treatment to the date of local progression, assessed up to 24 months

Study Arms (1)

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.

Radiation: Stereotactic Radiosurgery; Drug: Pazopanib Hydrochloride

Interventions

Stereotactic Radiosurgery RADIATION

3 fractions of 16 Gy per fraction to a total dose of 48 Gy on non-consecutive day within a 10 day time span

Also known as: SBRT, Stereotactic External Beam Irradiation, Stereotactic Radiation Therapy, Stereotactic Radiotherapy, Stereotactic Body Radiation Therapy

Treatment (Stereotactic Radiosurgery, pazopanib hydrochloride)

Pazopanib Hydrochloride DRUG

Given PO starting at 800mg to be systematically altered following drug related toxicities.

Also known as: GW786034B, Votrient, pazopanib

Treatment (Stereotactic Radiosurgery, pazopanib hydrochloride)

Eligibility Criteria

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

You may qualify if:

• 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
• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell; Neoplasms

Interventions

Radiosurgery; pazopanib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Kidney 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)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Rodney Ellis

  Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2014
• First Posted: December 4, 2014
• Study Start: September 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: March 3, 2016

Record last verified: 2016-03

Locations

US (2)