Clinical trial · Interventional
Second-Line Docetaxel + ASA404 for Advanced Urothelial Carcinoma
A Phase II Trial of Docetaxel Plus ASA404 as Second-Line Therapy in Patients With Advanced Urothelial Carcinoma: Hoosier Oncology Group GU09-144
NCT01071928CI-TRIAL-00018891withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of efficacy of experimental treatment
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Urothelial Carcinoma | Urothelial Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ASA404 | Drug | — | UNRESOLVED |
| Docetaxel | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Docetaxel and ASA404 in Combination
- interventionNames
- Drug: Docetaxel
- Drug: ASA404
Primary outcomes (1)
- measure
- To determine the best overall response rate (as measured by RECIST version 1.1) of docetaxel + ASA404 as second line therapy in patients with advanced urothelial carcinoma.
- timeFrame
- 12 months
Secondary outcomes (3)
- measure
- To evaluate progression-free survival in patients with advanced urothelial carcinoma
- timeFrame
- 12 months
- measure
- To evaluate survival at 1 year from start of treatment in patients with advanced urothelial carcinoma treated with docetaxel + ASA404 as second line therapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.