Transitional Cell Carcinoma of the BladderPhase 2NCT00859339
Neoadjuvant Cisplatin, Gemcitabine, Sunitinib Malate + Radical Cystectomy for TCC
A Phase 2 study testing Gemcitabine, Cisplatin and Sunitinib Malate in people with Transitional Cell Carcinoma of the Bladder, run by Noah Hahn, M.D. at 5 sites in 2 countries.
Trial summary
This trial will investigate the activity of sunitinib combined with cisplatin and gemcitabine followed by radical cystectomy in patients with Transitional Cell Carcinoma (TCC) of the Bladder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transitional Cell Carcinoma of the Bladder
- What is being tested?
- Gemcitabine, Cisplatin and Sunitinib Malate
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Mar 2009to Apr 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 proof of muscle-invasive transitional cell carcinoma of the bladder (stage II-III) with no evidence of metastatic disease (focal squamous and/or adenocarcinoma differentiation allowed, sarcomatoid and small-cell components not allowed). Patient with any degree of fixation of the pelvic sidewall are not eligible.
- Must be willing to undergo a cystoscopy if tumor block is not available prior to registration for protocol therapy.
- Eligible for radical cystectomy as per the attending urologist.
- Prior radiation therapy to bone marrow is allowed to < 25% of the marrow, and must be completed at least 6 months prior to registration for protocol therapy
- Written informed consent and HIPAA authorization for release of personal health information.
- Age > 18 years at the time of consent.
- 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 6 weeks after treatment discontinuation.
- Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for protocol therapy.
Who cannot join
- No prior radiotherapy to the pelvis.
- 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 cancer for which the patient has been disease-free for at least 5 years.
- No treatment with any investigational agent within 30 days prior to registration for protocol therapy.
- No cerebrovascular accident or transient ischemic attack within 6 months prior to registration for protocol therapy.
- No evidence of pulmonary embolism within 6 months prior to registration for protocol therapy.
- No uncontrolled hypertension (>150/100 mm Hg despite optimal medical therapy).
Show all 15Show fewer
- No evidence of ongoing cardiac dysrhythmias of NCI CTCAE Version 3.0 grade 2.
- No history of uncontrolled/untreated thyroid dysfunction.
- No prolonged QTc interval (> 450 msec) on pre-entry electrocardiogram obtained within 28 days prior to being registered on study.
- Patients on warfarin (>2mg) for thrombosis must be able and willing to switch to low molecular weight heparin prior to registration for protocol therapy.
- No use of drugs having proarrhythmic potential (terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, indapamide and flecainide) within 7 days prior to registration for protocol therapy.
- No use of CYP3A4 inhibitors (see section 5.3 for a list) within 7 days of registration for protocol therapy.
- No use of CYP3A4 inducers (see section 5.3 for a list) within 14 days of registration for protocol therapy.
- No use of amiodarone (CYP3A4 inhibitor) within 6 months of registration for protocol therapy.
- Females must not be breastfeeding.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
University of Florida
Gainesville, Florida, 32610
Baylor College of Medicine
Houston, Texas, 77030
Indiana University Simon Cancer Center
Indianapolis, Indiana, 46202
Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46601
United Kingdom1 site
St. Bartholomew's Hospital (Barts)
London, EC1A 7BE
About this study
Official title: A Phase II Trial of Neoadjuvant Cisplatin, Gemcitabine and Sunitinib Malate Followed by Radical Cystectomy for Transitional Cell Carcinoma (TCC) of the Bladder: Hoosier Oncology Group GU07-123
This trial will investigate the activity of sunitinib combined with cisplatin and gemcitabine followed by radical cystectomy in patients with Transitional Cell Carcinoma (TCC) of the Bladder.
Read the detailed description
OUTLINE: This is a multi-center study.
- Gemcitabine ( 1000 mg/m2) IV days 1 and 8
- Cisplatin (70 mg/m2) IV day 1 and
- Sunitinib malate (37.5 mg) oral daily for days 1-14
The treatment regimen will be administered in four, 21-day, cycles followed by radical cystectomy performed no sooner than 2 weeks but within 6 weeks of the last dose of sunitinib malate.
ECOG performance status 0 or 1
Hematopoietic:
- Absolute Neutrophil Count (ANC) > 1.5 K/mm3 [(IS): 1.5 x 109/L]
- Platelets > 100 K/mm3 [(IS): 100 x 109/L]
- Hemoglobin (Hgb) > 9.0 g/dL [(IS): 90 g/L]
Hepatic:
- Total bilirubin < 1.5 x Upper Limit of Normal (ULN)
- Aspartate aminotransferase (AST) ≤ 2.5 x ULN
- Alanine aminotransferase (ALT) ≤ 2.5 x ULN
Renal:
- Calculated creatinine clearance of > 60 cc/min
Cardiovascular:
- No uncontrolled angina, congestive heart failure or myocardial infarction or coronary/peripheral artery bypass graft within 6 months prior to registration for protocol therapy.
- Being tested
- Gemcitabine, Cisplatin, Sunitinib Malate, Radical Cystectomy
- Keywords
- TCC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
Gemcitabine ( 1000 mg/m2) IV days 1 and 8
CisplatinDrug
Cisplatin (70 mg/m2) IV day 1
Sunitinib MalateDrug
Sunitinib malate (37.5 mg) oral daily for days 1-14
Radical CystectomyProcedure or surgery
Radical cystectomy performed no sooner than 2 weeks but within 6 weeks of the last dose of sunitinib malate.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Treatment | Experimental | Neoadjuvant cisplatin, gemcitabine and sunitinib malate followed by radical cystectomy Receives: Drug: Gemcitabine; Drug: Cisplatin; Drug: Sunitinib Malate; Procedure: Radical Cystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response (pCR) Rate.
number of participants with a pCR
Measured: 18 months
Secondary outcomes (4)
Safety Profile
Evaluate the safety profile of Neoadjuvant Cisplatin, Gemcitabine, Sunitinib Malate + Radical Cystectomy in participants with TCC
Measured: 18 months
Objective Response Rate
To determine the objective response rate for patients with measurable disease according to RECIST.
Measured: 18 months
Progression Free Survival
Measured: 18 months
Correlate Biomarker Expression
To evaluate the impact of sunitinib malate in combination with cisplatin and gemcitabine on expression of selected biomarkers.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionApr 2011
- Study completionApr 2011
Why it stopped: Patient Toxicities
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Transitional Cell Carcinoma of the BladderStudies 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
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Noah Hahn, M.D.
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer, Hoosier Cancer Research Network
- Responsible party
- Sponsor-investigator, Noah Hahn, M.D., Hoosier Cancer Research Network
- Investigators
- Noah Hahn, M.D., Study chair, Hoosier Cancer Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00859339
- Sponsor's protocol ID
- HOG GU07-123
- Status last verified
- Mar 2016
- First submitted
- 9 Mar 2009
- Last updated
- 14 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Galsky MD, Hahn NM, Powles T, Hellerstedt BA, Lerner SP, Gardner TA, Yu M, O'Rourke M, Vogelzang NJ, Kocs D, McKenney SA, Melnyk AM Jr, Hutson TE, Rauch M, Wang Y, Asmar L, Sonpavde G. Gemcitabine, Cisplatin, and sunitinib for metastatic urothelial carcinoma and as preoperative therapy for muscle-invasive bladder cancer. Clin Genitourin Cancer. 2013 Jun;11(2):175-81. doi: 10.1016/j.clgc.2012.10.001. Epub 2012 Dec 8.
PubMed 23228446
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Neoadjuvant Cisplatin, Gemcitabine and Sunitinib Malate Followed by Radical Cystectomy for Transitional Cell Carcinoma (TCC) of the Bladder: Hoosier Oncology Group GU07-123
- ClinicalTrials.gov ID
- NCT00859339
- Acronym / sponsor ID
- HOG GU07-123
- Keywords
- TCC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Patient Toxicities
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Noah Hahn, M.D.University, hospital or other
- Collaborators
- Pfizer, Hoosier Cancer Research Network
- Study start
- Mar 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 11 Mar 2009 (estimated)
- Results
- Posted 14 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial will investigate the activity of sunitinib combined with cisplatin and gemcitabine followed by radical cystectomy in patients with Transitional Cell Carcinoma (TCC) of the Bladder.
Detailed description
OUTLINE: This is a multi-center study.
- Gemcitabine ( 1000 mg/m2) IV days 1 and 8
- Cisplatin (70 mg/m2) IV day 1 and
- Sunitinib malate (37.5 mg) oral daily for days 1-14
The treatment regimen will be administered in four, 21-day, cycles followed by radical cystectomy performed no sooner than 2 weeks but within 6 weeks of the last dose of sunitinib malate.
ECOG performance status 0 or 1
Hematopoietic:
- Absolute Neutrophil Count (ANC) > 1.5 K/mm3 [(IS): 1.5 x 109/L]
- Platelets > 100 K/mm3 [(IS): 100 x 109/L]
- Hemoglobin (Hgb) > 9.0 g/dL [(IS): 90 g/L]
Hepatic:
- Total bilirubin < 1.5 x Upper Limit of Normal (ULN)
- Aspartate aminotransferase (AST) ≤ 2.5 x ULN
- Alanine aminotransferase (ALT) ≤ 2.5 x ULN
Renal:
- Calculated creatinine clearance of > 60 cc/min
Cardiovascular:
- No uncontrolled angina, congestive heart failure or myocardial infarction or coronary/peripheral artery bypass graft within 6 months prior to registration for protocol therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Treatment | Experimental | Drug: Gemcitabine, Drug: Cisplatin, Drug: Sunitinib Malate, Procedure: Radical CystectomyNeoadjuvant cisplatin, gemcitabine and sunitinib malate followed by radical cystectomy |
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 proof of muscle-invasive transitional cell carcinoma of the bladder (stage II-III) with no evidence of metastatic disease (focal squamous and/or adenocarcinoma differentiation allowed, sarcomatoid and small-cell components not allowed). Patient with any degree of fixation of the pelvic sidewall are not eligible.
- Must be willing to undergo a cystoscopy if tumor block is not available prior to registration for protocol therapy.
- Eligible for radical cystectomy as per the attending urologist.
- Prior radiation therapy to bone marrow is allowed to < 25% of the marrow, and must be completed at least 6 months prior to registration for protocol therapy
- Written informed consent and HIPAA authorization for release of personal health information.
Key exclusion criteria (15 listed)
- No prior radiotherapy to the pelvis.
- 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 cancer for which the patient has been disease-free for at least 5 years.
- No treatment with any investigational agent within 30 days prior to registration for protocol therapy.
- No cerebrovascular accident or transient ischemic attack within 6 months prior to registration for protocol therapy.
- No evidence of pulmonary embolism within 6 months prior to registration for protocol therapy.
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 |
|---|---|---|
| GemcitabineGemcitabine ( 1000 mg/m2) IV days 1 and 8 | Drug | Experimental Treatment |
| CisplatinCisplatin (70 mg/m2) IV day 1 | Drug | Experimental Treatment |
| Sunitinib MalateSunitinib malate (37.5 mg) oral daily for days 1-14 | Drug | Experimental Treatment |
| Radical CystectomyRadical cystectomy performed no sooner than 2 weeks but within 6 weeks of the last dose of sunitinib malate. | Procedure or surgery | Experimental Treatment |
Primary outcome
Pathological Complete Response (pCR) Rate.
Time frame: 18 months
number of participants with a pCR
4 secondary outcomes
Safety Profile
Time frame: 18 months
Objective Response Rate
Time frame: 18 months
Progression Free Survival
Time frame: 18 months
Correlate Biomarker Expression
Time frame: 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23228446Galsky MD, Hahn NM, Powles T, Hellerstedt BA, Lerner SP, Gardner TA, Yu M, O'Rourke M, Vogelzang NJ, Kocs D, McKenney SA, Melnyk AM Jr, Hutson TE, Rauch M, Wang Y, Asmar L, Sonpavde G. Gemcitabine, Cisplatin, and sunitinib for metastatic urothelial carcinoma and as preoperative therapy for muscle-invasive bladder cancer. Clin Genitourin Cancer. 2013 Jun;11(2):175-81. doi: 10.1016/j.clgc.2012.10.001. Epub 2012 Dec 8.
- Hoosier Oncology Group HomepageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Noah Hahn, M.D. study chair
Hoosier Cancer Research Network
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gemcitabine, Cisplatin and Sunitinib Malate in people with Transitional Cell Carcinoma of the Bladder, run by Noah Hahn, M.D. at 5 sites in 2 countries.
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 15 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: stopped early, as of the sponsor's last update on 14 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 14 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pathological Complete Response (pCR) Rate. (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00859339, which also lists 1 linked publication.
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 14 Apr 2016.