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Trial record 1 of 1 for:    NCT00847015
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Gemcitabine, Cisplatin, and Sunitinib (GC-S) as Neoadjuvant Chemotherapy in Patients With Muscle-Invasive Bladder Cancer

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ClinicalTrials.gov Identifier: NCT00847015
Recruitment Status : Completed
First Posted : February 19, 2009
Results First Posted : February 29, 2016
Last Update Posted : February 29, 2016
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date  ICMJE February 18, 2009
First Posted Date  ICMJE February 19, 2009
Results First Submitted Date  ICMJE October 19, 2015
Results First Posted Date  ICMJE February 29, 2016
Last Update Posted Date February 29, 2016
Study Start Date  ICMJE February 2009
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2016)
The Pathologic Complete Response Rate (<pT0) of Neoadjuvant GCS Regimen in Patients With Muscle-invasive Bladder Cancer. [ Time Frame: 2 years ]
Complete pathologic response to neoadjuvant GCS is the primary endpoint is defined as the absence of carcinoma (pT0 disease) and the absence of microscopic lymph node metastases (N0) on the final cystectomy specimen.
Original Primary Outcome Measures  ICMJE
 (submitted: February 18, 2009)
  • To define the pathologic complete response rate (<pT0) of neoadjuvant GCS regimen in patients with muscle-invasive bladder cancer. [ Time Frame: conclusion of the study ]
  • To determine the safety of the GCS regimen in patients with urothelial cancer. [ Time Frame: conclusion of the study ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2016)
  • The Pathologic Response Rate (<pT2) of Neoadjuvant GCS Regimen in Patients With Muscle-invasive Bladder Cancer. [ Time Frame: 2 years ]
    is defined as the absence of muscle invasive carcinoma (<pT2 disease) and the absence of microscopic lymph node metastases (N0) on the final cystectomy specimen.
  • The Time to Disease Progression in Patients With Muscle Invasive Urothelial Carcinoma of the Bladder Treated With Neoadjuvant GCS Followed by Radical Cystectomy. [ Time Frame: 2 years ]
    The time to disease progression is measured from the time of initiation of chemotherapy until the first date that systemic recurrence is objectively documented. Systemic recurrence for this trial is defined as either metastatic or local pelvic recurrence.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 18, 2009)
  • To define the pathologic response rate (<pT2) of neoadjuvant GCS regimen in patients with muscle-invasive bladder cancer. [ Time Frame: conclusion of the study ]
  • To determine the time to disease progression in patients with muscle invasive urothelial carcinoma of the bladder treated with neoadjuvant GCS followed by radical cystectomy. [ Time Frame: conclusion of the study ]
  • To determine overall survival of patients with muscle-invasive urothelial carcinoma of the bladder treated with neoadjuvant GCS followed by radical cystectomy. [ Time Frame: conclusion of the study ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Gemcitabine, Cisplatin, and Sunitinib (GC-S) as Neoadjuvant Chemotherapy in Patients With Muscle-Invasive Bladder Cancer
Official Title  ICMJE Phase II Study of Gemcitabine, Cisplatin, and Sunitinib (GC-S) as Neoadjuvant Chemotherapy in Patients With Muscle-Invasive Bladder Cancer
Brief Summary The purpose of this study is to find out if using the combination of standard chemotherapy (gemcitabine and cisplatin) plus this new targeted pill (sunitinib) can help shrink your tumor before you undergo surgery for your bladder cancer.
Detailed Description Not Provided
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
  • Bladder Cancer
  • Urinary Bladder
Intervention  ICMJE
  • Drug: Sunitinib
    Sunitinib will be administered at a dose of 25mg orally once daily for 2 consecutive weeks followed by a 1 week rest period.
  • Drug: Gemcitabine
    Gemcitabine 1,000 mg/m^2
  • Drug: cisplatin
    cisplatin 35 mg/m^2 will be administered intravenously on days 1 and 8.
Study Arms  ICMJE Experimental: Gemcitabine, Cisplatin, and Sunitinib
This is a phase II study of GCS (Gemcitabine, Cisplatin, and Sunitinib) as neoadjuvant chemotherapy in patients with muscle-invasive urothelial carcinoma of the bladder. Patients with muscle invasive urothelial carcinoma who are candidates for radical cystectomy will be enrolled.
Interventions:
  • Drug: Sunitinib
  • Drug: Gemcitabine
  • Drug: cisplatin
Publications * Not Provided

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: February 8, 2012)
18
Original Estimated Enrollment  ICMJE
 (submitted: February 18, 2009)
45
Actual Study Completion Date  ICMJE November 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically confirmed muscle invasive transitional cell carcinoma of the bladder at MSKCC.
  • Clinical stage T2-T4a N0/X M0 disease.
  • Medically appropriate candidate for radical cystectomy as per MSKCC attending urologic oncologist.
  • Karnofsky Performance Status ≥ 70%.
  • Age ≥ 18 years of age.
  • Required Initial Laboratory Values:

    • Absolute neutrophil count ≥ 1500 cells/mm3
    • Platelets ≥ 100,000 cells/mm3
    • Hemoglobin ≥ 9.0g/dL
    • Bilirubin ≤ 1.5 the upper limit of normal (ULN) for the institution
    • Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN for the institution
    • Alkaline phosphatase ≤ 2.5 x ULN for the institution
    • Serum creatinine ≤ 1.5 mg/dL
  • Estimated glomerular filtration rate ≥ 60 ml/min/1.73m2 using the CKD-EPI equation:
  • eGFR = 141 x min(Scr/k, 1)a x max(Scr/k, 1)-1.209 x 0.993Age
  • x 1.018 [if female] x 1.159 [if black]
  • Scr is serum creatinine, k is 0.7 for females and 0.9 for males, a is -0.329 for females and -0.411 for males, min indicates the minimum of Scr/k or 1, and max indicates the maximum of Scr/k or 1.
  • If female of childbearing potential, pregnancy test is negative.
  • Patients with reproductive potential must use an effective method to avoid pregnancy for the duration of the trial.

Exclusion Criteria:

  • Prior systemic chemotherapy (prior intravesical therapy is allowed)
  • Prior radiation therapy to the bladder
  • Evidence of NYHA functional class III or IV heart disease.
  • Serious intercurrent medical or psychiatric illness, including serious active infection.
  • Preexisting sensory grade 3 neuropathy
  • Major surgery or radiation therapy < 4 weeks of starting study treatment.
  • Concomitant use of any other investigational drugs
  • Any of the following within the 6 months prior to study drug administration:

myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism.

  • Ongoing cardiac dysrhythmias of NCI CTCAE Version 3.0 grade ≥ 2.
  • Prolonged QTc interval on baseline EKG (>450 msec for males and >470 msec for females).
  • Uncontrolled hypertension (>150/100 mmHg despite optimal medical therapy).
  • Pre-existing thyroid abnormality, with thyroid function tests that cannot be maintained in the normal range with medication.
  • Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness or other active infection.
  • Concurrent treatment on another clinical trial. Supportive care trials or non-treatment trials, e.g. QOL, are allowed.
  • Ongoing treatment with therapeutic doses of warfarin (low dose warfarin up to 2 mg po daily for thromboembolic prophylaxis is allowed).
  • Pregnancy or breast-feeding. Patients must be surgically sterile or be postmenopausal,or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate. Male patients must be surgically sterile or agree to use effective contraception.
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 States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00847015
Other Study ID Numbers  ICMJE 08-159
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Dean Bajorin, MD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date February 2016

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