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A Phase II Trial of Adjuvant Bevacizumab and Erlotinib in Patients at High Risk for Early Relapse Following Radical Prostatectomy for Prostate Cancer


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

A Phase II Trial of Adjuvant Bevacizumab and Erlotinib in Patients at High Risk for Early Relapse Following Radical Prostatectomy for Prostate Cancer


This study explores the anti-tumor activity of adjuvant bevacizumab plus erlotinib in a
select group of prostate cancer patients deemed at high risk for early relapse following
radical prostatectomy.


Inclusion Criteria:



- Karnofsky performance status of > 80

- Patients must have localized, organ-confined prostate cancer documented by physical
examination, CT scan, or bone scan, and must have undergone radical prostatectomy.
Post RP must have documented node negative prostate cancer.

- Pretreatment granulocyte count > 1500/mm3, hemoglobin > 9.0 g/dL, and platelet count
> 100,000/mm3,

- Normal PT and PTT

- Serum creatinine < 2.0 mg/dL

- Adequate hepatic function with a serum bilirubin < upper limit of normal (ULN), AST
and ALT < 1.5x ULN, and alkaline phosphatase < 2.5x ULN.

- High-risk prostate cancer defined as a pre-RP prostate specific antigen level > 15
ng/dL or a Gleason score of > 8 or Stage T3 disease or positive surgical margins

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

Exclusion Criteria:

- Evidence of small cell (neuroendocrine) tumor

- Evidence of metastatic disease

- Prior administration of immunotherapy, biological therapy, hormonal therapy or
radiation therapy for prostate cancer

- Active secondary malignancies (other than basal cell carcinoma of the skin)

- Serious, nonhealing wound, ulcer, or bone fracture.

- Clinically significant cardiovascular disease (e.g., blood pressure of >150/100 mmHg,
myocardial infarction, or unstable angina), New York Heart Association (NYHA) Grade
II or greater congestive heart failure, serious cardiac arrhythmia requiring
medication, or clinically significant peripheral vascular disease. Patients with a
history of myocardial infarction or stroke within the last 6 months will be excluded.

- Presence of seizures not controlled with standard medical therapy

- Active infection requiring parenteral antibiotics at the time of the first
administration of study drugs

- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to Day 0, or anticipation of need for major surgical procedure during the
course of the study; minor surgical procedures, fine needle aspirations or core
biopsies within 7 days prior to Day 0.

- Current, recent (within the 4 weeks preceding Day 0), or planned participation in
another experimental drug study

- Inability to comply with the study visit and follow-up schedule or procedures

- History of other disease, metabolic dysfunction, physical examination finding, or
clinical laboratory finding giving reasonable suspicion of a disease or condition
that contraindicates the use of an investigational drug or that might affect the
interpretation of the results of the study or render the subject at high risk from
treatment complications.

- Urine protein:creatinine ration > 1.0 at screening

- Evidence of bleeding diathesis or coagulopathy.

- History of abdominal fistula, gastrointestinal perforation, or intraabdominal abscess
within 28 days prior to Day 0.

- Presence of central nervous system or brain metastases

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To Evaluate the Efficacy of Bevacizumab Plus Erlotinib

Outcome Time Frame:

Determined by time to tumor recurrence, as measured by rising prostate specific antigen (PSA) after radical prostatectomy.

Safety Issue:

Yes

Principal Investigator

Fairooz Kabbinavar, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Chief Medical Officer, TORI

Authority:

United States: Food and Drug Administration

Study ID:

TORI GU-01

NCT ID:

NCT00203424

Start Date:

January 2006

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms

Name

Location

Comprehensive Cancer Centers of NevadaLas Vegas, Nevada  89109
Wilshire Oncology Medical Group, Inc.Rancho Cucamonga, California  91730
Comprehensive Blood and Cancer CenterBakersfield, California  93309
Pacific Shores Medical GroupLong Beach, California  90813
UCLA Medical CenterLos Angeles, California  90095-7059
San Diego Cancer CenterVista, California  92083
Virginia K. Crosson Cancer CenterFullerton, California  92835
North Valley Hematology/Oncology Medical GroupNorthridge, California  91328
Ventura County Hematology-Oncology SpecialistsOxnard, California  93030
Santa Barbara Hematology Oncology Medical Group, Inc.Santa Barbara, California  93105
Cancer Care Associates Medical Group, Inc.Torrance, California  90505
Central Hematology Oncology Medical Group, Inc.Alhambra, California  91801
Sansum Santa Barbara Medical Foundation ClinicSanta Barbara, California  93105
Cancer Institute of Florida, P.A.Orlando, Florida  32804
Central Coast Medical Oncology CorporationSanta Maria, California  93454
South Texas Oncology and Hematology, P.A.San Antonio, Texas  78207