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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00588666
• Date of registration: 26/12/2007
• Primary sponsor: Memorial Sloan-Kettering Cancer Center
• Public title: Phase II Trial of Gemcitabine, Carboplatin, and Bevacizumab in Chemotherapy Naive Patients With Advanced/Metastatic Urothelial Carcinoma
• Scientific title: Phase II Trial of Gemcitabine, Carboplatin, and Bevacizumab in Chemotherapy Naive Patients With Advanced/Metastatic Urothelial Carcinoma
• Date of first enrolment: May 2006
• Target sample size: 51
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00588666
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Dean Bajorin, MD
• Affiliation: Memorial Sloan-Kettering Cancer Center

Key inclusion & exclusion criteria

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
screening

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Cancer

Myeloproliferative Disorder

Urothelial Carcinoma

Intervention(s)

Drug: Bevacizumab, Carboplatin, Gemcitabine

Primary Outcome(s)

Evaluate the time to disease progression; To define the safety of combination therapy with bevacizumab, gemcitabine, and carboplatin in patients with advanced/metastatic TCC. [Time Frame: 3 years]

Secondary Outcome(s)

To define the response rate of combination therapy with bevacizumab, gemcitabine, and carboplatin in patients with advanced/metastatic TCC. [Time Frame: 3 years]

Secondary ID(s)

06-006

Source(s) of Monetary Support

Please refer to primary and secondary sponsors