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A Phase II Trial of Docetaxel Plus ASA404 as Second-Line Therapy in Patients With Advanced Urothelial Carcinoma: Hoosier Oncology Group GU09-144


Phase 2
18 Years
N/A
Not Enrolling
Both
Urothelial Carcinoma

Thank you

Trial Information

A Phase II Trial of Docetaxel Plus ASA404 as Second-Line Therapy in Patients With Advanced Urothelial Carcinoma: Hoosier Oncology Group GU09-144


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


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome 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.

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Matthew Galsky, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Hoosier Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

GU09-144

NCT ID:

NCT01071928

Start Date:

June 2010

Completion Date:

March 2013

Related Keywords:

  • Urothelial Carcinoma
  • Advanced Urothelial Carcinoma
  • Carcinoma
  • Carcinoma, Transitional Cell

Name

Location

Medical Consultants, P.C.Muncie, Indiana  47303
Indiana University Melvin & Bren Simon Cancer CenterIndianapolis, Indiana  46202