In this phase II multicenter study, the investigators aim to evaluate the efficacy and
tolerability of a novel taxane-cabazitaxel as single agent second-line chemotherapy for
metastatic urothelial carcinoma.
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Full eligibility criteria for NCT01600339
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
Ages eligible for this study are 18 years and older.
Histological or cytological diagnosis of urothelial carcinoma. Mixed histologies are permitted as long as transitional cell carcinoma is the major component (i.e. > 50% of the pathologic specimen). Pure or predominant squamous cell carcinomas are not permitted.
Patients with transitional cell carcinomas of the renal pelvis and ureter are permitted.
Patients must have metastatic or locally advanced unresectable disease.
Patients must have received one and only one prior chemotherapeutic regimen which included platinum (at least one cycle) for metastatic/recurrent disease. Neoadjuvant or adjuvant chemotherapy will be considered to have been first line if the patient progressed within 12 months of the last dose.
Patients with disease progression more than 12 months following platinum based chemotherapy can be included (rather than platinum re-challenge), according to the investigator's judgment.
ECOG performance status ≤ 2
Estimated life expectancy of > 12 weeks.
Patients must have measurable disease according to RECIST1.1 criteria.
If female of childbearing potential, pregnancy test is negative within 8 days priors to first dose of study drug.
If fertile, patient agrees to use an effective method of contraception to avoid pregnancy for the duration of the study.
Adequate organ function; Absolute neutrophil count ≥1.5 x 109/L. Platelet count ≥ 100 x109/L. Hemoglobin ≥ 9 g/dL. Total bilirubin ≤1.0x upper limit of normal. AST/SGOT and/or ALT/SGPT ≤ 2.5x upper limit of normal. Calculated creatinine clearance > 40 ml/min (creatinine clearance will be calculated according to CKD-EPI formula: http://www.qxmd.com/calculate-online/nephrology/ckd-epi-egfr).(27)
Able to give informed consent.
Prior taxane therapy.
Pregnant or lactating females
Uncontrolled brain or leptomeningeal involvement (treated brain metastasis permitted if both known lesions and medications e.g. steroids for that indication are stable).
History of serious or concurrent illness that might be aggravated by study treatment.
Known human immunodeficiency virus (HIV) infection or active hepatitis B/C.
History of class II-IV congestive heart failure.
Significant renal impairment.
History of severe hypersensitivity reaction (≥grade 3) to docetaxel.
History of severe hypersensitivity reaction (≥grade 3) to polysorbate 80 containing drugs.
Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who are already on these treatments) (see Appendix).
Other malignancies except adequately controlled basal cell carcinoma of the skin or carcinoma in situ of the cervix or incidental prostate cancer (T1a, Gleason < 7 PSA < 10ng/ml) or any other tumor within 2 years prior to enrollment.
Other investigational therapy or radiation therapy within 30 days before registration.
Patients not willing to employ adequate contraception for the duration of the study.
All locations for NCT01600339
Rabin Medical Center
Petah Tikva, Israel
View full eligibility
Tris trial is registered with FDA with number: NCT01600339. The sponsor of the trial is Rambam Health Care Campus and it is looking for 19 volunteers for the current phase.
Official trial title: A Single Arm, Multicenter, Open-label Phase II Trial of Cabazitaxel as Second Line Treatment of Patients With Locally Advanced or Metastatic Urothelial Carcinoma
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