Clinical trial NCT01071928 (phase 2, status: withdrawn)
Conditions: urothelial carcinoma
ICD codes: C22.0, C22.1, C4A.9, C7B.1, D09.9, C4A.0, C4A.31
Drugs: docetaxel, asa404
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, CC1=C(C)C2=C(C=C1)C(=O)C1=CC=CC(CC(O)=O)=C1O2
Reason stopped: 
    lack of efficacy of experimental treatment
  
Eligibility criteria:

        Inclusion Criteria:

          -  Histological or cytological proof of transitional cell carcinoma (TCC) of the bladder,
             urethra, ureter, or renal pelvis (urothelial carcinoma). Histology may be mixed, but
             still requires a component of TCC.

          -  Measurable disease according to RECIST (version 1.1) and obtained by imaging within 30
             days prior to registration for protocol therapy. Note: Sites of measurable disease can
             not be within a previously irradiated site.

          -  Written informed consent and HIPAA authorization for release of personal health
             information.

          -  Age > 18 years at the time of consent.

          -  Must have received only one prior chemotherapy regimen, which must have included one
             of the following chemotherapeutic agents: cisplatin, carboplatin, or gemcitabine.
             Note: Prior chemotherapy may have been administered in the perioperative
             (neoadjuvant/adjuvant) or advanced/metastatic setting. Patients may have received
             prior treatment with paclitaxel.

          -  Females of childbearing potential and males must be willing to use an effective method
             of contraception (hormonal or barrier method of birth control; abstinence) from the
             time consent is signed until 12 weeks after treatment discontinuation.

          -  Females of childbearing potential must have a negative pregnancy test within 7 days
             prior to registration for protocol therapy.

          -  Females must not be breastfeeding.

        Exclusion Criteria:

          -  No prior treatment with docetaxel.

          -  No symptomatic brain metastases. Patients with neurological symptoms must undergo a
             head CT scan or brain MRI to exclude brain metastasis. NOTE: Patients with treated
             brain metastasis must be off steroids and have completed radiation at least 14 days
             prior to registration for protocol therapy.

          -  No prior malignancy is allowed except for adequately treated basal cell or squamous
             cell skin cancer, in situ cervical cancer, Gleason < grade 7 prostate cancers, or
             other cancers for which the patient has been disease-free for at least 5 years

          -  No treatment with any investigational agent or chemotherapeutic agent within 30 days
             prior to registration for protocol therapy.

          -  No radiotherapy within 14 days prior to registration for protocol therapy. Patients
             must have recovered from all radiotherapy-related toxicities.

          -  No major surgery within 30 days prior to registration for protocol therapy (major
             surgery is defined by the use of general anesthesia).

          -  No minor surgery 14 days prior to registration for protocol therapy. NOTE: Insertion
             of a vascular access device is allowed.

          -  No history of any medical condition resulting in ≥ CTC grade 2 dyspnea.

          -  Patients without long QT syndrome

          -  No history of labile hypertension or poor compliance with anti-hypertensive regimen
             NOTE: No patients with systolic BP >140 mm Hg and/or diastolic BP > 90 mm Hg while on
             medication for hypertension.

          -  No presence of atrial tachyarrhythmia (e.g., atrial fibrillation, atrial flutter,
             multifocal atrial tachycardia, supraventricular tachycardia) if not effectively
             rate-controlled.

          -  No history of a sustained ventricular tachycardia

          -  No history of ventricular fibrillation or Torsades de Pointes

          -  No right bundle branch block and left anterior or posterior hemiblock (bifascicular
             block)

          -  No bradycardia defined as heart rate <50 beats per minute

          -  No concomitant use of drugs with risk of causing Torsades de Pointes.

          -  No concomitant use of drugs that are inducers and inhibitors of UGT1A9 and UGT2B7.