Second-Line Docetaxel + ASA404 for Advanced Urothelial Carcinoma

This study has suspended participant recruitment.
(Budgetary issues)
Novartis Pharmaceuticals
Information provided by:
Hoosier Cancer Research Network Identifier:
First received: February 18, 2010
Last updated: August 20, 2010
Last verified: August 2010

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.

Condition Intervention Phase
Urothelial Carcinoma
Drug: Docetaxel
Drug: ASA404
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Docetaxel Plus ASA404 as Second-Line Therapy in Patients With Advanced Urothelial Carcinoma: Hoosier Oncology Group GU09-144

Resource links provided by NLM:

Further study details as provided by Hoosier Cancer Research Network:

Primary Outcome Measures:
  • 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. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate progression-free survival in patients with advanced urothelial carcinoma [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • To evaluate survival at 1 year from start of treatment in patients with advanced urothelial carcinoma treated with docetaxel + ASA404 as second line therapy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • To evaluate the safety of docetaxel and ASA404 combination, as measured by the NCI Common Toxicity Criteria version 3.0 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: June 2010
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Docetaxel and ASA404 in Combination Drug: Docetaxel
Docetaxel IV 75 mg/m2 over approximately 60 minutes on Day 1
Drug: ASA404
ASA404 (given after Docetaxel)IV 1800 mg/m2 over approximately 20 minutes on Day 1

Detailed Description:

OUTLINE: This is a multi-center study.

21 Day Cycle Treatment Regimen:

  • Docetaxel IV 75 mg/m2 over approximately 60 minutes on Day 1
  • ASA404 (given after Docetaxel) IV 1800 mg/m2 over approximately 20 minutes on Day 1

Treatment will continue until disease progression or intolerable treatment related adverse effects.

Karnofsky performance status of ≥ 70% within 7 days prior to registration for protocol therapy.

Life Expectancy: Not specified


  • Hemoglobin (Hgb) > 9 g/dL
  • Platelets > 100 K/mm3
  • Absolute neutrophil count (ANC) > 1.5 K/mm3
  • INR or Prothrombin Time (PT) < 1.5 x ULN


  • Bilirubin < 1.5 x ULN
  • Aspartate aminotransferase (AST, ALT) < 2.5 x ULN


  • Calculated creatinine clearance of > 45 cc/min using the Cockcroft-Gault formula


  • No congestive heart failure (NY Heart Association class III or IV)
  • No myocardial infarction within 12 months of study registration for protocol therapy or with implanted cardiac pacemaker
  • No unstable or poorly controlled angina pectoris, including Prinzmetal variant angina pectoris

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01071928

United States, Indiana
Indiana University Melvin & Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Medical Consultants, P.C.
Muncie, Indiana, United States, 47303
Sponsors and Collaborators
Hoosier Cancer Research Network
Novartis Pharmaceuticals
Study Chair: Matthew Galsky, M.D. Hoosier Cancer Research Network
  More Information

No publications provided

Responsible Party: Matthew Galsky, M.D., Hoosier Oncology Group Identifier: NCT01071928     History of Changes
Other Study ID Numbers: GU09-144
Study First Received: February 18, 2010
Last Updated: August 20, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Hoosier Cancer Research Network:
Advanced Urothelial Carcinoma

Additional relevant MeSH terms:
Carcinoma, Transitional Cell
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators processed this record on July 01, 2015