Brief Title
Second-Line Docetaxel + ASA404 for Advanced Urothelial Carcinoma
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
Brief 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.
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
Hematopoietic:
- 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
Hepatic:
- Bilirubin < 1.5 x ULN
- Aspartate aminotransferase (AST, ALT) < 2.5 x ULN
Renal:
- Calculated creatinine clearance of > 45 cc/min using the Cockcroft-Gault formula
Cardiovascular:
- 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
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
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.
Secondary Outcome
To evaluate progression-free survival in patients with advanced urothelial carcinoma
Condition
Urothelial Carcinoma
Intervention
Docetaxel
Study Arms / Comparison Groups
Docetaxel and ASA404 in Combination
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
0
Start Date
June 2010
Completion Date
June 2010
Primary Completion Date
June 2010
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Matthew Galsky, M.D., ,
Administrative Informations
NCT ID
NCT01071928
Organization ID
GU09-144
Responsible Party
Principal Investigator
Study Sponsor
Hoosier Cancer Research Network
Collaborators
Novartis Pharmaceuticals
Study Sponsor
Matthew Galsky, M.D., Study Chair, Hoosier Cancer Research Network
Verification Date
August 2015