Treatment of Prostate Cancer With Adjuvant Bevacizumab Plus Erlotinib

Completed · Phase 2

Conditions studied: Prostate Cancer

In brief

The purpose of this study is to evaluate the safety and effectiveness of bevacizumab plus erlotinib following radical prostatectomy.

Key facts

Study ID

NCT00203424

Run by

Translational Oncology Research International

People needed

23

Starts

2006-01-01

Expected to finish

2010-06-01

Last updated by the study team

2016-03-25

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Central Hematology Oncology Medical Group, Inc. — Alhambra, California, United States
• Comprehensive Blood and Cancer Center — Bakersfield, California, United States
• Virginia K. Crosson Cancer Center — Fullerton, California, United States
• Pacific Shores Medical Group — Long Beach, California, United States
• UCLA Medical Center — Los Angeles, California, United States
• North Valley Hematology/Oncology Medical Group — Northridge, California, United States
• Ventura County Hematology-Oncology Specialists — Oxnard, California, United States
• Wilshire Oncology Medical Group, Inc. — Pomona, California, United States
• Cancer Care Associates Medical Group, Inc. — Redondo Beach, California, United States
• Sansum Santa Barbara Medical Foundation Clinic — Santa Barbara, California, United States
• Santa Barbara Hematology Oncology Medical Group, Inc. — Santa Barbara, California, United States
• Central Coast Medical Oncology Corporation — Santa Maria, California, United States
• San Diego Cancer Center — Vista, California, United States
• Cancer Institute of Florida, P.A. — Orlando, Florida, United States
• Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
• South Texas Oncology and Hematology, P.A. — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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