Status:
COMPLETED
VEGF Trap in Treating Patients With Recurrent, Locally Advanced, or Metastatic Cancer of the Urothelium
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adenocarcinoma of the Bladder
Distal Urethral Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This phase II trial is studying the side effects and how well VEGF Trap works in treating patients with recurrent, locally advanced, or metastatic cancer of the urothelium. VEGF Trap may stop the grow...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the response rate in patients with recurrent, locoregionally advanced, or metastatic transitional cell carcinoma of the urothelium treated with VEGF Trap. II. Determ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Histologically confirmed transitional cell carcinoma (TCC) of the urothelium
- Must have predominance of transitional histology, but foci of squamous and/or adenocarcinoma histology allowed
- Poorly differentiated transitional cell carcinoma allowed
- TCC of any of the following sites allowed:
- Bladder
- Renal pelvis
- Ureter
- Urethra
- Measurable disease, defined as \>= 1 unidimensionally measurable lesion \>= 20 mm by conventional techniques OR \>= 10 mm by spiral CT scan
- Locoregionally advanced or metastatic disease that is not amenable to curative surgery and/or radiotherapy
- Must have received 1 prior systemic chemotherapy regimen containing a platinum compound (e.g., cisplatin, carboplatin, or oxaliplatin) in the neoadjuvant, adjuvant, or metastatic setting
- No evidence of CNS disease, including primary brain tumor or brain metastases
- ECOG performance status 0-2
- Absolute neutrophil count \>= 1,000/mm\^3
- Platelet count \>= 75,000/mm\^3
- Bilirubin =\< 1.5 times upper limit of normal (ULN)
- AST or ALT =\< 2.5 times ULN
- Creatinine =\< 2.5 times ULN OR creatinine clearance =\> 40 mL/min
- Urine protein: creatinine ratio =\< 1 OR 24-hour urine protein \< 500 mg
- INR =\< 1.5 (unless on full-dose warfarin)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for \>= 6 months after completion of study treatment
- No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
- No history of allergic reactions attributed to compounds of similar chemical or biological composition to other agents used in the study
- No serious or nonhealing wound, ulcer, or bone fracture
- No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
- No significant traumatic injury within the past 28 days
- No clinically significant cardiovascular disease, including any of the following:
- Myocardial infarction, coronary artery bypass graft, or unstable angina pectoris within the past 6 months
- New York Heart Association class III or IV congestive heart failure
- Serious cardiac arrhythmia requiring medication
- Clinically significant peripheral vascular disease within the past 6 months
- Cerebrovascular accident within the past 6 months
- Pulmonary embolism, deep vein thrombosis, or other thromboembolic event within the past 6 months
- Uncontrolled hypertension, defined as blood pressure (BP) \> 150/100 mm Hg or systolic BP \> 180 mm Hg (if diastolic BP \< 90 mm Hg) within the past 3 months
- No evidence of bleeding diathesis or coagulopathy
- No uncontrolled intercurrent illness, including, but not limited to, any of the following:
- Ongoing or active infection
- Psychiatric illness or social situation that would preclude study compliance
- Recovered from prior therapy
- Prior biologic or targeted therapies allowed
- No more than 1 prior systemic chemotherapy regimen for metastatic disease
- No prior antiangiogenic therapy primarily targeting the vascular endothelial growth factor pathway
- At least 4 weeks since prior radiotherapy or systemic therapy (6 weeks for mitomycin C or nitrosoureas)
- More than 28 days since prior major surgery or open biopsy
- More than 7 days since prior core biopsy
- No concurrent major surgery
- Concurrent full-dose anticoagulants (e.g., warfarin) allowed provided all of the following criteria are met:
- In-range INR (usually between 2 and 3) on a stable dose of oral anticoagulant or low molecular weight heparin
- No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)
- No other concurrent investigational agents
- No concurrent combination antiretroviral therapy for HIV-positive patients
Exclusion
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00407485
Start Date
November 1 2006
End Date
April 1 2014
Last Update
October 20 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
City of Hope
Duarte, California, United States, 91010