Know Cancer

or
forgot password

A Phase II Study of VEGF Trap (NSC 724770) in Patients With Recurrent or Metastatic Transitional Carcinoma of the Urothelium


Phase 2
18 Years
N/A
Not Enrolling
Both
Adenocarcinoma of the Bladder, Distal Urethral Cancer, Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter, Proximal Urethral Cancer, Recurrent Bladder Cancer, Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter, Recurrent Urethral Cancer, Squamous Cell Carcinoma of the Bladder, Stage III Bladder Cancer, Stage III Urethral Cancer, Stage IV Bladder Cancer, Transitional Cell Carcinoma of the Bladder, Urethral Cancer Associated With Invasive Bladder Cancer

Thank you

Trial Information

A Phase II Study of VEGF Trap (NSC 724770) in Patients With Recurrent or Metastatic Transitional Carcinoma of the Urothelium


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. Determine the time to progression in patients treated with this drug. III. Determine
overall survival of patients treated with this drug. IV. Determine the tolerability and
safety of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the
absence of disease progression or unacceptable toxicity.

Patients undergo blood collection periodically during study for
pharmacokinetic/pharmacodynamic correlative studies.

After completion of study treatment, patients are followed periodically.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Tumor response rate

Outcome Time Frame:

From the start of the treatment until disease progression or recurrence, assessed up to 4 years

Safety Issue:

No

Principal Investigator

Przemyslaw Twardowski

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beckman Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02840

NCT ID:

NCT00407485

Start Date:

November 2006

Completion Date:

Related Keywords:

  • Adenocarcinoma of the Bladder
  • Distal Urethral Cancer
  • Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter
  • Proximal Urethral Cancer
  • Recurrent Bladder Cancer
  • Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter
  • Recurrent Urethral Cancer
  • Squamous Cell Carcinoma of the Bladder
  • Stage III Bladder Cancer
  • Stage III Urethral Cancer
  • Stage IV Bladder Cancer
  • Transitional Cell Carcinoma of the Bladder
  • Urethral Cancer Associated With Invasive Bladder Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Urinary Bladder Neoplasms
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Carcinoma, Transitional Cell
  • Urethral Neoplasms
  • Kidney Neoplasms
  • Ureteral Neoplasms

Name

Location

City of Hope Duarte, California  91010