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 @ 11:28 PM
Ignite Modification Date:
2025-12-24 @ 11:28 PM
NCT ID:
NCT00496756
Eligibility Criteria:
DISEASE CHARACTERISTICS:
Inclusion Criteria:
* Histologically or cytologically confirmed renal cell carcinoma (RCC)
* Must have a component of conventional clear cell RCC
* Predominant clear cell component ≥ 75%
* Metastatic or unresectable disease (Measurable disease is defined as any lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan or MRI)
* Measurable or nonmeasurable disease, includes any of the following:
* Small lesions, longest diameter \< 20 mm by conventional techniques or \< 10 mm by spiral CT scan
* Bone lesions
* Leptomeningeal disease
* Ascites
* Pleural/pericardial effusion
* Lymphangitis cutis/pulmonitis
* Abdominal masses that are not confirmed and followed by imaging techniques
* Cystic lesions
* Irradiated lesions, unless progression is documented after radiotherapy
* Paraffin RCC tissue blocks or unstained slides must be obtained for future chemistry staining of VEGF
* Karnofsky performance status 70-100%
* Fertile patients must use effective contraception (hormonal and/or barrier method) during and for 3 months after completion of study treatment
* Granulocyte count ≥ 1,500/µL
* Platelet count ≥ 100,000/µL
* AST/ALT ≤ 2.5 times upper limit of normal (ULN)
* Alkaline phosphatase ≤ 2.5 times ULN
* Serum bilirubin ≤ 1.5 times ULN
* Protein ≤ 1+ by urinalysis
* Creatinine ≤ 1.5 times ULN
* At least 4 weeks since prior major surgery and/or radiotherapy and recovered
* Prior palliative radiotherapy for metastatic lesion(s) allowed provided there is at least one measurable and/or evaluable lesion(s) that has not been irradiated
* More than 4 weeks since prior and no other concurrent anticancer therapy
* Concurrent continuation of bisphosphonates allowed for bone metastases prophylaxis
Exclusion Criteria:
* Patients with true papillary, sarcomatoid features without any clear cell component, chromophobe, oncocytoma, collecting duct tumors, or transitional cell carcinoma are not eligible
* No evidence of CNS metastases
* No imaging (MRI or CT scan of the brain) abnormality indicative of CNS metastases within past 42 days
* Not pregnant or nursing (negative pregnancy test)
* No ongoing hemoptysis
* No cerebrovascular accident within the past 12 months
* No peripheral vascular disease with claudication while walking less than 1 block
* No history of clinically significant bleeding
* No deep venous thrombosis or pulmonary embolus within the past year
* No significant cardiovascular disease, defined as NYHA class II-IV congestive heart failure, angina pectoris requiring nitrate therapy, or myocardial infarction within the past 6 months
* No uncontrolled hypertension, defined as systolic BP \> 160 mm Hg and/or diastolic BP \> 90 mm Hg while on medication
* No preexisting thyroid abnormality whose thyroid function cannot be maintained in the normal range by medication
* No uncontrolled psychiatric disorder
* No delayed healing of wounds, ulcers, and/or bone fractures
* No currently active second malignancy except nonmelanoma skin cancer (patients are not considered to have a 'currently active' malignancy if they have completed anticancer therapy and are considered by their physician to be at less than 30% risk of relapse)
* No more than one prior systemic therapy for RCC
* No prior vascular endothelial growth factor receptor agents
* No concurrent systemic corticosteroid therapy (except replacement therapy for adrenal insufficiency)
o Topical and/or inhaled steroids allowed
* No concurrent full-dose oral or parenteral anticoagulation
o Low-dose warfarin (1 mg) for maintenance of catheter patency or daily prophylactic aspirin allowed
* No concurrent Hypericum perforatum (St. John's wort)
* No concurrent ketoconazole, itraconazole, ritonavir, rifampin, or products containing grapefruit juice
* No concurrent hormonal therapy or chemotherapy o Concurrent hormones administered for non-disease related conditions (e.g., insulin for diabetes) allowed
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00496756
Study Brief:
Protocol Section:
NCT00496756