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:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 1:22 AM
NCT ID:
NCT00068393
Eligibility Criteria:
INCLUSION CRITERIA:
* Histologically confirmed renal cell carcinoma
* Features must be of sarcomatoid histology
* Locally recurrent or metastatic disease not amenable to resection
* Measurable disease
* Must have a prior nephrectomy provided all other eligibility criteria are met, and adequately recovered from any recent surgery
* At least 4 weeks since prior radiotherapy and recovered
* ECOG performance status of 0-1
* WBC greater than 3,000/mm\^3 or absolute neutrophil count greater than 1,500/mm\^3
* Platelet count greater than 100,000/mm\^3
* Bilirubin less than 1.5 mg/dL
* Aspartate aminotransferase (AST) less than 2 times upper limit of normal
* Creatinine no greater than 2.0 mg/dL
* LVEF at least lower limit of normal by MUGA
* Negative pregnancy test
* Fertile patients must use effective contraception
* Other prior malignancy allowed provided patient was curatively treated and has been disease free from that cancer
* Age of 18 and over
* Diagnostic material from the kidney or metastatic site biopsy available for central pathologic review
EXCLUSION CRITERIA:
* Prior treatment for advanced disease
* Previously irradiated lesions as the sole site of disease for patients with prior radiation therapy
* Concurrent local radiotherapy for pain control or for life-threatening situations
* Myocardial infarction within the past year
* Congestive heart failure within the past year
* Significant ischemic or valvular heart disease within the past year
* Prior or concurrent brain metastases
* Concurrent serious medical illness that would preclude study treatment
* Active infection that would preclude study treatment
* Pregnant or nursing
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00068393
Study Brief:
Protocol Section:
NCT00068393