Neoadjuvant Cisplatin, Gemcitabine, Sunitinib Malate + Radical Cystectomy for TCC

NCT00859339

Last updated date
Study Location
University of Florida
Gainesville, Florida, 32610, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Transitional Cell Carcinoma of the Bladder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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).


- 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.

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Transitional Cell Carcinoma of the BladderNeoadjuvant Cisplatin, Gemcitabine, Sunitinib Malate + Radical Cystectomy for TCC
NCT00859339
  1. Gainesville, Florida
  2. Indianapolis, Indiana
  3. South Bend, Indiana
  4. Houston, Texas
  5. London,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Neoadjuvant Cisplatin, Gemcitabine, Sunitinib Malate + Radical Cystectomy for TCC
Official Title  ICMJE 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
Brief 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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Transitional Cell Carcinoma of the Bladder
Intervention  ICMJE
  • Drug: Gemcitabine
    Gemcitabine ( 1000 mg/m2) IV days 1 and 8
  • Drug: Cisplatin
    Cisplatin (70 mg/m2) IV day 1
  • Drug: Sunitinib Malate
    Sunitinib malate (37.5 mg) oral daily for days 1-14
  • Procedure: Radical Cystectomy
    Radical cystectomy performed no sooner than 2 weeks but within 6 weeks of the last dose of sunitinib malate.
Study Arms  ICMJE Experimental: Experimental Treatment
Neoadjuvant cisplatin, gemcitabine and sunitinib malate followed by radical cystectomy
Interventions:
  • Drug: Gemcitabine
  • Drug: Cisplatin
  • Drug: Sunitinib Malate
  • Procedure: Radical Cystectomy
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 11, 2011)
9
Original Estimated Enrollment  ICMJE
 (submitted: March 10, 2009)
46
Actual Study Completion Date  ICMJE April 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00859339
Other Study ID Numbers  ICMJE HOG GU07-123
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party Noah Hahn, M.D., Hoosier Cancer Research Network
Study Sponsor  ICMJE Noah Hahn, M.D.
Collaborators  ICMJE
  • Pfizer
  • Hoosier Cancer Research Network
Investigators  ICMJE
Study Chair:Noah Hahn, M.D.Hoosier Cancer Research Network
PRS Account Hoosier Cancer Research Network
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP