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 @ 4:07 PM
Ignite Modification Date:
2025-12-24 @ 4:07 PM
NCT ID:
NCT01090466
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed transitional cell carcinoma of the urothelium
* Pure or mixed histology
* Upper or lower urinary tract
* Radiologically evaluable\* locally advanced and/or metastatic disease not amenable to curative treatment with surgery or radiotherapy, meeting any 1 of the following criteria:
* T4b, any N, any M
* Any T, N2-3, any M
* Any T, any N, M1
* NOTE: \*Patients enrolled in the phase II portion of the trial must have radiologically measurable disease.
* No transitional cell cancer for which subsequent radical treatment is being considered with a view to possibly cure the disease
* No history of CNS metastases
PATIENT CHARACTERISTICS:
* WHO performance status 0-2
* Life expectancy ≥ 3 months
* Absolute neutrophil count ≥ 1.5 x 10\^9/L
* Platelet count ≥ 100 x 10\^9/L
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* ALT and ALP ≤ 2.5 times ULN
* PT or INR ≤ 1.5
* GFR ≥ 60 mL/min (uncorrected for surface area and measured by isotopic means)
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Fit to receive cisplatin-containing combination chemotherapy
* No previous malignancy other than nonmelanoma skin cancer, carcinoma in situ of the cervix, or incidental localized prostate cancer
* No known HIV positivity or chronic hepatitis B or C infection
* No symptomatic coronary artery disease, myocardial infarction within the past 6 months, congestive cardiac failure (NYHA class III or IV disease), or uncontrolled or symptomatic cardiac arrhythmia
* No clinically significant bacterial or fungal infection
PRIOR CONCURRENT THERAPY:
* At least 1 month since prior radiotherapy or radiotherapy involving more than 30% of total bone marrow volume
* At least 1 month since prior investigational drug
* No prior systemic therapy for locally advanced or metastatic disease
* Patients who have received prior neoadjuvant or adjuvant chemotherapy for urothelial cancer (up to 4 courses), completed at least 6 months prior to first documented disease progression are eligible
* No concurrent anticoagulant therapy with warfarin or unfractionated heparin
* Patients requiring anticoagulation may be entered on study after successful conversion to low molecular weight heparin
* No concurrent medications which have known adverse interactions with the treatment used on this trial (e.g., CYP3A4 inhibitors or inducers in phase I of this trial)
* No prior or concurrent live vaccines (e.g., measles, mumps, rubella, oral polio, Bacille Calmette-Guérin \[BCG\], yellow fever, varicella, and TY21a typhoid vaccines)
* No concurrent grapefruit juice
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
120 Years
Study:
NCT01090466
Study Brief:
Protocol Section:
NCT01090466