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Phase II Trial of Gemcitabine, Carboplatin, and Bevacizumab in Chemotherapy Naive Patients With Advanced/Metastatic Urothelial Carcinoma

Phase 2
18 Years
Not Enrolling
Myeloproliferative Disorder, Urothelial Carcinoma, Cancer

Thank you

Trial Information

Phase II Trial of Gemcitabine, Carboplatin, and Bevacizumab in Chemotherapy Naive Patients With Advanced/Metastatic Urothelial Carcinoma

This is a phase II trial of gemcitabine, carboplatin, and bevacizumab in chemotherapy naïve
patients with advanced/metastatic transitional cell carcinoma (TCC) of the urothelial tract.

Inclusion Criteria:

- Histologic documentation: diagnosis of transitional cell carcinoma of the
bladder,urethra, ureter, or renal pelvis.

- Unresectable or metastatic disease

- Ineligible for cisplatin (or incurable with cisplatin)

- ≥ 4 weeks since prior RT

- Karnofsky Performance Status ≥ 60%

- Age ≥ 18 years of age

- Required Initial Laboratory Values: Absolute neutrophil count ≥ 1.2 x 109/L;
Platelets ≥ 100 x 109/L; Bilirubin ≤ 1.5 times the upper limit of normal (x ULN) for
the institution; Aspartate transaminase (AST) and alanine transaminase(ALT) ≤ 3.0 x
ULN;Serum creatinine < 2.0 or calculated creatinine clearance (CrCl) ≥ 30 mL/min

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 other than a Genentech-sponsored
bevacizumab cancer study

- Blood pressure of >150/100 mmHg

- Unstable angina

- New York Heart Association (NYHA) Grade II or greater congestive heart failure

- History of myocardial infarction within 6 months

- History of stroke 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

- Anticipation of need for major surgical procedure during the course of the study

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

- Pregnant (positive pregnancy test) or lactating

- Albuminuria as demonstrated by a urinary albumin of greater or = to 1.0 g/24 hr at

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

- Serious, non-healing wound, ulcer, or bone fracture

- Inability to comply with study and/or follow-up procedures

- History of persistent gross hematuria

Type of Study:


Study Design:

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

Outcome Measure:

Evaluate the time to disease progression; To define the safety of combination therapy with bevacizumab, gemcitabine, and carboplatin in patients with advanced/metastatic TCC.

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Dean Bajorin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

May 2006

Completion Date:

December 2011

Related Keywords:

  • Myeloproliferative Disorder
  • Urothelial Carcinoma
  • Cancer
  • Myeloproliferative Disorder
  • urinary bladder
  • Cancer
  • ureter
  • renal pelvis
  • chemotherapy
  • Carcinoma
  • Carcinoma, Transitional Cell
  • Myeloproliferative Disorders



Memorial Sloan-Kettering Cancer Center New York, New York  10021
Memorial Sloan-Kettering Cancer Center at Mercy Medical Center Rockville Centre, New York  11570
Memorial Sloan-Kettering at Basking Ridge Basking Ridge, New Jersey  07920
Memoral Sloan Kettering Cancer Center Basking Ridge, New Jersey  
Memorial Sloan-Kettering Cancer Center @ Suffolk Commack, New York  11725
Memoral Sloan Kettering Cancer Center@Phelps Sleepy Hollow, New York