Second-Line Docetaxel + ASA404 for Advanced Urothelial Carcinoma

• Status: Withdrawn
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to explore the safety and activity of docetaxel + ASA404 as second-line chemotherapy in patients with advanced urothelial carcinoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoosier Cancer Research Network
• Collaborator: Novartis Pharmaceuticals
• Treatments: Docetaxel; Vadimezan

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.