Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-24 @ 7:24 PM
NCT ID:
NCT00126503
Eligibility Criteria:
Inclusion Criteria:
* PHASE I ELIGIBILITY CRITERIA
* Patients must have histological or cytological confirmation of renal cell carcinoma (clear cell, papillary, chromophobe, or sarcomatoid) not curable by standard approaches; tumor must be measurable by Response Evaluation Criteria In Solid Tumors (RECIST) criteria; nephrectomy prior to enrollment is not required
* Patients may not have had prior therapy with inhibitors of the mitogen-activated protein (MAP) kinase pathway or inhibitors of VEGF and/or its receptor signaling (VEGFR2)
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Life expectancy of greater than 3 months
* Hemoglobin (Hgb) \>= 9.0gm/dl (transfusions allowed prior to enrollment)
* White Blood Count \>= 3,000/mm\^3
* Absolute Granulocyte Count \>= 1,200/mm\^3
* Platelet Count \>= 100,000/mm\^3
* Serum creatinine =\< 1.5 x upper limit of normal (ULN) or serum creatinine clearance (CrCl) \>= 40ml/min (neither drug is cleared by the kidney)
* Total Bilirubin =\< 1.5 x ULN
* Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 2.5 x ULN
* International normalized ratio (INR) =\< 1.5 and activated partial thromboplastin time (aPTT) that is not greater than 1.3 times the ULN
* Urine Dipstick must show less then 1+ protein in urine or the patient will require 24 hour urine collection with total protein =\< 1000 mg/24 hour
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant while participating in this study, she should inform her treating physician immediately
* Ability to understand and the willingness to sign a written informed consent document
* PHASE II ELIGIBILITY CRITERIA
* Patients enrolled on the phase II portion of the study will be required to have predominantly clear cell variant of renal cell carcinoma with less than 25% of any other histology (papillary or chromophobe or oncocytic); there must be histologic confirmation by treating center of either primary or metastatic lesion; patients must be willing to consent for obtaining tumor tissue blocks or unstained slides from prior biopsy or surgery; patients who participated in the Phase I part of the protocol will not be part of the accrual to the Phase II cohort
* Patients enrolled on the phase II portion of the study will be required to have measurable disseminated disease that is not curable by standard radiation therapy or surgery
* Previous nephrectomy is required with the following exceptions:
* Primary tumor =\< 5cm or
* Extensive liver (\> 30% of liver parenchymal) or multiple (\> 5) bone metastases, or extensive extrarenal tumor or unresectable local/regional tumor extension making nephrectomy a clinically questionable and unreasonable procedure
* For the phase II study, patients will be allowed no more than one prior regimen containing a vaccine or cytokine based immunotherapy or chemotherapy for advanced disease
* Hgb \>= 9.0gm/dl (transfusions allowed prior to enrollment)
* White Blood Count \>= 3,000/mm\^3 (phase II)
* Absolute Granulocyte Count \>= 1,200/mm\^3 (phase II)
* Platelet Count \>= 100,000/mm\^3 (phase II)
* Serum creatinine =\< 1.5 x upper limit of normal (ULN) or serum creatinine clearance (CrCl) \>= 40ml/min (neither drug is cleared by the kidney) (phase II)
* Total Bilirubin =\< 1.5 x ULN (phase II)
* AST/ALT =\< 2.5 x ULN
* INR =\< 1.5
* Urine Dipstick must show less then 1+ protein in urine or the patient will require 24 hour urine collection with total protein =\< 1000 mg/24 hour (phase II)
* No prior malignancy diagnosed within the past 3 years with the exception of non-melanoma skin cancers, melanoma in situ, carcinoma in situ of the cervix, ductal carcinoma in situ, and lobular carcinoma in situ; any prior malignancy must have a very likely cure rate (75% or greater)
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant while participating in this study, she should inform her treating physician immediately (phase II)
* Ability to understand and the willingness to sign a written informed consent document (phase II)
Exclusion Criteria:
* History or clinical evidence of central nervous system (CNS) disease, including primary brain tumor (participants with a history of meningioma are not excluded), seizures not controlled with standard medical therapy, any brain metastasis, or history of stroke within the prior 12 months; patients who have had a history of brain metastasis that have been resected or have had radiosurgery with no progression for more than 6 months are eligible if the Principle Investigator from the coordinating center is consulted and agrees
* Patients entered onto the phase II study may not have received more than one chemotherapy or immunotherapy regimen for Stage IV disease
* Patients may not have received chemotherapy or immunotherapy within 4 weeks of initiating treatment; patients will not have received a regimen containing a monoclonal antibody within 8 weeks of initiating treatment; toxicities from radiation must have resolved and a minimum of two weeks must pass prior to enrollment
* Patients may not have had prior anti-angiogenic therapy including, Sunitinib, VEGF Trap; prior Temsirilomus, Everolimus, Bevacizumab and Sorafenib will not be allowed; thalidomide or interferon (IFN) alpha are allowed either for adjuvant therapy or stage IV disease
* History of allergic reactions attributed to Chinese hamster ovary cell products, other recombinant human antibodies, or compounds of similar chemical or biologic composition to Sorafenib
* History of bleeding diathesis or coagulopathy
* A condition that impairs patient's ability to swallow pills will make patient ineligible
* No major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to initiation of therapy on trial
* Anticipation of the need for major surgery during the course of the study
* Current or recent use (within 7 days of starting the study drugs) of full-dose of anticoagulants (except as required to maintain patency of preexisting, permanent indwelling IV catheters or for deep vein thrombosis \[DVT\] prophylaxis, for subjects receiving warfarin, INR should be =\< 1.5) or thrombolytic agent
* Patients with uncontrolled hypertension; blood pressure must be =\< 150/90 mmHg at the time of enrollment on a stable antihypertensive regimen
* Patients with clinically significant cardiovascular disease within 1 year prior to study entry
* Uncontrolled hypertension
* Myocardial infarction or unstable angina \< 6 months prior to registration
* New York heart association grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication (participants with controlled atrial arrhythmias are not excluded), unstable angina pectoris
* Grade II or greater peripheral vascular disease
* Serious, non-healing wound, ulcer, or bone fracture
* Significant proteinuria (\> 1000 mg protein/24 hours ) at baseline; subjects discovered to have \>= 1+ proteinuria on dipstick should undergo a 24-hour urine collection, which should contain \< 1000 mg protein/ 24 hours to be allowed participation in the study
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring parental antibiotics, or psychiatric illness/social situations that would limit compliance with study requirements
* Patients taking cytochrome P450 enzyme-inducing antiepileptic drugs will be excluded (phenytoin, carbamazepine, Phenobarbital, rifampin, and St.John's Wort)
* Pregnant and lactating women are excluded from the study; breastfeeding should be discontinued while receiving therapy
* Human immunodeficiency virus (HIV)-positive patients receiving combination anti-retroviral therapy are excluded from the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00126503
Study Brief:
Protocol Section:
NCT00126503