Second-Line Docetaxel + ASA404 for Advanced Urothelial Carcinoma

This study has suspended participant recruitment.
(Budgetary issues)
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by:
Hoosier Oncology Group
ClinicalTrials.gov Identifier:
NCT01071928
First received: February 18, 2010
Last updated: August 20, 2010
Last verified: August 2010
  Purpose

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 Oncology Group:

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

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01071928

Locations
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 Oncology Group
Novartis Pharmaceuticals
Investigators
Study Chair: Matthew Galsky, M.D. Hoosier Oncology Group
  More Information

No publications provided

Responsible Party: Matthew Galsky, M.D., Hoosier Oncology Group
ClinicalTrials.gov 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 Oncology Group:
Advanced Urothelial Carcinoma

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
5,6-dimethylxanthenoneacetic acid
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014