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

NCT ID: NCT00847015

Last Updated: 2016-02-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2012-11-30

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.

Conditions

Bladder Cancer; Urinary Bladder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Sunitinib

Intervention Type: DRUG

Sunitinib will be administered at a dose of 25mg orally once daily for 2 consecutive weeks followed by a 1 week rest period.

Gemcitabine

Intervention Type: DRUG

Gemcitabine 1,000 mg/m\^2

cisplatin

Intervention Type: DRUG

cisplatin 35 mg/m\^2 will be administered intravenously on days 1 and 8.

Interventions

Sunitinib

Sunitinib will be administered at a dose of 25mg orally once daily for 2 consecutive weeks followed by a 1 week rest period.

Intervention Type: DRUG

Gemcitabine

Gemcitabine 1,000 mg/m\^2

Intervention Type: DRUG

cisplatin

cisplatin 35 mg/m\^2 will be administered intravenously on days 1 and 8.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dean Bajorin, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan-Kettering at Basking Ridge

Basking Ridge, New Jersey, United States

Memorial Sloan-Kettering Cancer Center @ Suffolk

Commack, New York, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Memorial Sloan-Kettering Cancer Center at Mercy Medical Center

Rockville Centre, New York, United States

Memoral Sloan Kettering Cancer Center@Phelps

Sleepy Hollow, New York, United States

Countries

United States

Related Links

http://www.mskcc.org

Memorial Sloan-Kettering Cancer Center

Other Identifiers

08-159

Identifier Type: -

Identifier Source: org_study_id