Clinical trial NCT00683059 (phase 2, status: completed)
Conditions: transitional cell carcinoma
ICD codes: C22.0, C4A.9, C7B.1, C4A.0, C4A.31, C4A.51, C4A.8
Drugs: paclitaxel
SMILES: [H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\C=C(C)\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\C=C\C=C\C=C(C)\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC
Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have 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 a 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.

          -  Neoadjuvant/adjuvant chemotherapy (with or without a taxane) is permitted if
             registration is greater than 12 months since the last dose (patients must then have
             received one platinum containing regimen in the metastatic setting)

          -  ECOG performance status <= 2.

          -  Estimated life expectancy of >12 weeks.

          -  Patients must have measurable disease according to RECIST criteria.

          -  If female of childbearing potential, pregnancy test is negative within 72 hours 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 >90 g/L. Total bilirubin <1.5x upper limit of normal. Transaminases
             <3x upper limit of normal (<5x if liver metastasis are present) Calculated creatinine
             clearance >40 ml/min (Cockcroft & Gault formula)

          -  Able to give informed consent.

        Exclusion Criteria:

          -  Prior taxane therapy for metastatic disease (or > 12 months since a taxane-containing
             neoadjuvant or adjuvant chemotherapy).

          -  Pre-existing peripheral neuropathy >1 by NCI-CTC criteria.

          -  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.

          -  History of class II-IV congestive heart failure.

          -  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 5 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.