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 @ 3:04 PM
Ignite Modification Date:
2025-12-24 @ 3:04 PM
NCT ID:
NCT00126659
Eligibility Criteria:
Inclusion Criteria:
* Patients with histologically or cytologically confirmed metastatic clear cell RCC who are eligible for cytoreductive nephrectomy as agreed upon by Medical Oncology and Urology team members; patients with metastatic disease eligible for cytoreductive nephrectomy should have the following characteristics: resectable primary tumor (no gross adjacent organ invasion, no or minimal abdominal lymphadenopathy, no or minimal inferior vena caval involvement), bulk of metastatic disease within the primary tumor, absence of multiple liver metastases, no more than 2 organ sites involved with metastases
* Patients must have measurable disease, defined as a lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) and measures \>= 20 mm with conventional techniques or \>= 10 mm with spiral computed tomography (CT) scan
* ECOG performance status =\< 1
* Absolute neutrophil count \>= 1,500/uL
* Platelets \>= 100,000/uL
* Hgb \> 9.0 g/dL
* Total bilirubin =\< 2.0 mg/dl
* Albumin \> 3.0 g/dL
* Serum creatinine =\< 2.0 mg/dl
* AST (SGOT) and/or ALT (SGPT) =\< 2.5 x institutional upper limit of normal for subjects without evidence of liver metastases
* AST (SGOT) and/or ALT (SGPT) =\< 5 X institutional upper limit of normal for subjects with documented liver metastases
* Female patients of childbearing potential must have a normal plasma beta human chorionic gonadotropin (beta-HCG) within 24 hours prior to enrolling in the study due to the possible teratogenic effect; however, patients will be eligible if their beta-HCG is elevated and is determined to be due to malignancy
* Patients of child fathering or childbearing potential must agree to practice a form of medically acceptable birth control while on study
* Patients must give written informed consent prior to initiation of therapy, in keeping with the policies of the institution; patients with a history of major psychiatric illness must be judged able to fully understand the investigational nature of the study and the risks associated with the therapy
* Patients must have ability to comply with study and/or follow-up procedures
* Prior biopsy material (blocks or unstained slides) must be available for comparison purposes
Exclusion Criteria:
* No prior malignancy is allowed, except for non-melanoma skin cancer, in situ carcinoma of any site, or other cancers for which the patient has been adequately treated and disease free for 5 years
* Patients must not have received any systemic anticancer therapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
* Patients must not be scheduled to receive another experimental drug while on this study; patients are permitted to be on concomitant bisphosphonates
* Patients who are incapable of swallowing pills are excluded from this study
* Patients must not have a primary brain tumor, any brain metastases, leptomeningeal disease, seizure disorders not controlled with standard medical therapy, or history of stroke
* Patients must not have active acute infections that could be worsened by anticancer therapy or interfere with this study
* Patients must not have clinically significant cardiovascular disease, recent myocardial infarction (i.e. last 6 months), (unstable angina), New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac dysrhythmia requiring medication, or peripheral vascular disease (grade II or greater)
* Patients must not have history of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications
* Patients with uncontrolled hypertension \> 140/90 are excluded from the study
* Patients must not have any history of bleeding diathesis; patients must not be on therapeutic anticoagulation; prophylactic anticoagulation (i.e. low dose coumadin) of venous or arterial access devices is allowed provided that the requirements for PT, INR or PTT are met
* Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with BAY 43-9006
* HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00126659
Study Brief:
Protocol Section:
NCT00126659