Gemcitabine, Cisplatin, and Sunitinib (GC-S) as Neoadjuvant Chemotherapy in Patients With Muscle-Invasive Bladder Cancer

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00847015
First received: February 18, 2009
Last updated: February 1, 2016
Last verified: February 2016

February 18, 2009
February 1, 2016
February 2009
November 2012   (final data collection date for primary outcome measure)
The Pathologic Complete Response Rate (<pT0) of Neoadjuvant GCS Regimen in Patients With Muscle-invasive Bladder Cancer. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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.
  • 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 ] [ Designated as safety issue: No ]
  • To determine the safety of the GCS regimen in patients with urothelial cancer. [ Time Frame: conclusion of the study ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00847015 on ClinicalTrials.gov Archive Site
  • The Pathologic Response Rate (<pT2) of Neoadjuvant GCS Regimen in Patients With Muscle-invasive Bladder Cancer. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
  • To define the pathologic response rate (<pT2) of neoadjuvant GCS regimen in patients with muscle-invasive bladder cancer. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Gemcitabine, Cisplatin, and Sunitinib (GC-S) as Neoadjuvant Chemotherapy in Patients With Muscle-Invasive Bladder Cancer
Phase II Study of Gemcitabine, Cisplatin, and Sunitinib (GC-S) as Neoadjuvant Chemotherapy in Patients With Muscle-Invasive Bladder Cancer
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.
Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Bladder Cancer
  • Urinary Bladder
  • 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.
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
November 2012
November 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00847015
08-159
Yes
Not Provided
Not Provided
Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
Pfizer
Principal Investigator: Dean Bajorin, MD Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
February 2016

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