Urothelial CarcinomaPhase 2NCT01071928
Second-Line Docetaxel + ASA404 for Advanced Urothelial Carcinoma
A Phase 2 study testing Docetaxel and ASA404 in people with Urothelial Carcinoma, run by Hoosier Cancer Research Network.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Carcinoma
- What is being tested?
- Docetaxel and ASA404
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2010to Jun 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
About this study
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
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.
Read the 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
- Conditions
- Urothelial Carcinoma
- Being tested
- Docetaxel, ASA404
- Keywords
- Advanced Urothelial Carcinoma
- Medical subject headings
- Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
Docetaxel IV 75 mg/m2 over approximately 60 minutes on Day 1
ASA404Drug
ASA404 (given after Docetaxel)IV 1800 mg/m2 over approximately 20 minutes on Day 1
| Study group | Role | What they receive |
|---|---|---|
| Docetaxel and ASA404 in Combination | Experimental | Not described Receives: Drug: Docetaxel; Drug: ASA404 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (3)
To evaluate progression-free survival in patients with advanced urothelial carcinoma
Measured: 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
Measured: 12 months
To evaluate the safety of docetaxel and ASA404 combination, as measured by the NCI Common Toxicity Criteria version 3.0
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2010 (estimated)
- Study startJun 2010
- Primary completionJun 2010
- Study completionJun 2010
Why it stopped: Lack of efficacy of experimental treatment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urothelial CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoosier Cancer Research Network
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Principal investigator, Matthew Galsky, Hoosier Cancer Research Network
- Investigators
- Matthew Galsky, M.D., Study chair, Hoosier Cancer Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01071928
- Sponsor's protocol ID
- GU09-144
- Status last verified
- Aug 2015
- First submitted
- 18 Feb 2010
- Last updated
- 19 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01071928
- Acronym / sponsor ID
- GU09-144
- Conditions
- Urothelial Carcinoma
- Keywords
- Advanced Urothelial Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of efficacy of experimental treatment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hoosier Cancer Research NetworkUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- Jun 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 19 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Docetaxel and ASA404 in Combination | Experimental | Drug: Docetaxel, Drug: ASA404 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DocetaxelDocetaxel IV 75 mg/m2 over approximately 60 minutes on Day 1 | Drug | Docetaxel and ASA404 in Combination |
| ASA404ASA404 (given after Docetaxel)IV 1800 mg/m2 over approximately 20 minutes on Day 1 | Drug | Docetaxel and ASA404 in Combination |
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.
Time frame: 12 months
3 secondary outcomes
To evaluate progression-free survival in patients with advanced urothelial carcinoma
Time frame: 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
Time frame: 12 months
To evaluate the safety of docetaxel and ASA404 combination, as measured by the NCI Common Toxicity Criteria version 3.0
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Galsky, M.D. study chair
Hoosier Cancer Research Network
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Docetaxel and ASA404 in people with Urothelial Carcinoma, run by Hoosier Cancer Research Network.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2015.