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Phase II Study of Gemcitabine and Split-dose Cisplatin (GC) Plus Sorafenib in Chemotherapy-naïve Patients With Locally Advanced or Metastatic Urothelial Carcinoma

Phase 2
18 Years
Not Enrolling

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Trial Information

Phase II Study of Gemcitabine and Split-dose Cisplatin (GC) Plus Sorafenib in Chemotherapy-naïve Patients With Locally Advanced or Metastatic Urothelial Carcinoma

Inclusion Criteria:

- Patients must have measurable or evaluable urothelial cancer.

- Measurable disease includes unresectable or metastatic urothelial tract tumors
that are unidimensionally measurable by xray,CT/MRI scan or physical

- Evaluable disease is restricted to patients with unresectable primary bladder
tumors which can be evaluated for response by cystoscopy.

- Pathologic confirmation by the Department of Pathology at MSKCC.

- Karnofsky Performance Status (KPS) ≥60%.

- Adequate marrow function defined as granulocytes ≥ 1500 cells/mm 3 , platelets ≥
100,000 cells/mm 3 , and hemoglobin ≥ 8.0 g/dl.

- Serum creatinine < 2.0 mg/dl

- 24-hour urine sample demonstrating creatinine clearance ≥ 60 ml/min/1.73m2 or
calculated creatinine clearance ≥ 60 ml/min/1.73m 2 using the formula: Jeliffe
Equation: estimated creatinine clearance = 98 x (0.8 [age(yrs) 20]/Serum Creatinine
(mg/dL) x (0.9 if Female))

- Adequate hepatic function defined as:

- Total Bilirubin < or = to 1.5 x ULN

- AST and ALT < or = to 3.0 x ULN (< or = to 5.0 x ULN is acceptable if liver has
tumor involvement)

- Normal coagulation profile including PT/INR and PTT, unless patient is receiving
anticoagulation therapy with agents such as warfarin or heparin.

- Age ≥ 18 years

- Informed consent

- Women of childbearing potential must have a negative pregnancy test.

- Men and women of childbearing potential must be willing to consent to using effective
contraception while on treatment and for at least 3 months thereafter.

- Patients are encouraged to continue barrier method contraception for two years or
longer after treatment.

Exclusion Criteria:

- Prior treatment with systemic chemotherapy (prior intravesical therapy is permitted).

- Current, recent (within 4 weeks of the first infusion of this study), or planned
participation in an experimental drug study.

- Blood Pressure of > 150/100 mm Hg.

- Irradiation within 4 weeks of start of protocol.

- Evidence of another active cancer, except for nonmelanoma skin carcinoma, insitu
carcinoma of the cervix curatively treated, and adenocarcinoma of the prostate that
has been surgically treated with a post-treatment PSA that is nondetectable.

- Significant cardiovascular disease including congestive heart failure (New York Heart
Association Class II or higher) or active angina pectoris.

- History of a myocardial infarction within 6 months.

- History of a stroke or transient ischemic attack within 6 months.

- Clinically significant peripheral vascular disease.

- Evidence of bleeding diathesis or coagulopathy.

- Presence of central nervous system or brain metastases.

- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to Day 0.

- Minor surgical procedures such as fine needle aspirations or core biopsies within 7
days prior to Day 0.

- History of abdominal fistula, gastrointestinal perforation, or intraabdominal abscess
within 6 months prior to Day 0.

- Serious nonhealing wound, ulcer, or bone fracture.

- History of persistent gross hematuria.

- Uncontrolled infection.

- Hypersensitivity to sorafenib, or any component of the formulation.

- Pregnant (positive pregnancy test) or lactating.

- Inability to comply with the study and/or followup procedures.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the progression free survival rate at one year for previously untreated patients with advanced/metastatic urothelial carcinoma treated with the combination of sorafenib, gemcitabine, and cisplatin.

Outcome Time Frame:

conclusion of the study

Safety Issue:


Principal Investigator

Matthew Milowsky, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

July 2008

Completion Date:

November 2011

Related Keywords:

  • Bladder Cancer
  • Bladder
  • Urinary
  • Urinary Bladder Neoplasms
  • Carcinoma
  • Carcinoma, Transitional Cell



Memorial Sloan Kettering Cancer Center New York, New York  10021