Second-Line Docetaxel + ASA404 for Advanced Urothelial Carcinoma

NCT01071928 | Withdrawn Phase 2 DMC

• 1 other identifier: GU09-144
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Urothelial Carcinoma

Keywords

Advanced Urothelial Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (3)

• To evaluate progression-free survival in patients with advanced urothelial carcinoma

  12 months

• To evaluate survival at 1 year from start of treatment in patients with advanced urothelial carcinoma treated with docetaxel + ASA404 as second line therapy

  12 months

• To evaluate the safety of docetaxel and ASA404 combination, as measured by the NCI Common Toxicity Criteria version 3.0

  12 months

Study Arms (1)

Docetaxel and ASA404 in Combination

EXPERIMENTAL

Drug: Docetaxel; Drug: ASA404

Interventions

Docetaxel DRUG

Docetaxel IV 75 mg/m2 over approximately 60 minutes on Day 1

Docetaxel and ASA404 in Combination

ASA404 DRUG

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

Docetaxel and ASA404 in Combination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoosier Cancer Research Network: lead
• Novartis Pharmaceuticals: collaborator

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Interventions

Docetaxel; vadimezan

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Matthew Galsky, M.D.

  Hoosier Cancer Research Network

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 18, 2010
• First Posted: February 19, 2010
• Study Start: June 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: August 19, 2015

Record last verified: 2015-08