Gemcitabine, Cisplatin, and Sunitinib (GC-S) as Neoadjuvant Chemotherapy in Patients With Muscle-Invasive Bladder Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
Memorial Sloan-Kettering Cancer Center
Collaborator:
Pfizer
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00847015
First received: February 18, 2009
Last updated: February 8, 2012
Last verified: February 2012
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Purpose
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.
Condition | Intervention | Phase |
---|---|---|
Bladder Cancer Urinary Bladder |
Drug: Gemcitabine, Cisplatin, and Sunitinib |
Phase 2 |
Study Type: | Interventional |
Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
Official Title: | Phase II Study of Gemcitabine, Cisplatin, and Sunitinib (GC-S) as Neoadjuvant Chemotherapy in Patients With Muscle-Invasive Bladder Cancer |
Resource links provided by NLM:
Genetics Home Reference related topics:
bladder cancer
Drug Information available for:
Cisplatin
Gemcitabine
Gemcitabine hydrochloride
Sunitinib malate
Sunitinib
U.S. FDA Resources
Further study details as provided by Memorial Sloan-Kettering Cancer Center:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
Enrollment: | 18 |
Study Start Date: | February 2009 |
Estimated Study Completion Date: | February 2013 |
Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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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.
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Drug: Gemcitabine, Cisplatin, and Sunitinib
Patients will receive four cycles of GCS administered every 21 days followed by radical cystectomy. Sunitinib will be administered at a dose of 25mg orally once daily for 2 consecutive weeks followed by a 1 week rest period. Gemcitabine 1,000 mg/m2 and cisplatin 35 mg/m2 will be administered intravenously on days 1 and 8.
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Eligibility
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00847015
Locations
United States, New Jersey | |
Memorial Sloan-Kettering at Basking Ridge | |
Basking Ridge, New Jersey, United States, 07920 | |
United States, New York | |
Memorial Sloan-Kettering Cancer Center @ Suffolk | |
Commack, New York, United States, 11725 | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10065 | |
Memorial Sloan-Kettering Cancer Center at Mercy Medical Center | |
Rockville Centre, New York, United States, 11570 | |
Memoral Sloan Kettering Cancer Center@Phelps | |
Sleepy Hollow, New York, United States |
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Pfizer
Investigators
Principal Investigator: | Dean Bajorin, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
Keywords provided by Memorial Sloan-Kettering Cancer Center:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 26, 2012
Additional Information:
No publications provided
Responsible Party: | Memorial Sloan-Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00847015 History of Changes |
Other Study ID Numbers: | 08-159 |
Study First Received: | February 18, 2009 |
Last Updated: | February 8, 2012 |
Health Authority: | United States: Institutional Review Board |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
Bladder Urinary CISPLATIN |
GEMCITABINE SU011248 (Sunitinib Malate) 08-159 |
Additional relevant MeSH terms:
Urinary Bladder Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Urinary Bladder Diseases Urologic Diseases Gemcitabine Sunitinib Cisplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents |
Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |
ClinicalTrials.gov processed this record on September 26, 2012