Clinical trial NCT00203424: Treatment of Prostate Cancer With Adjuvant Bevacizumab Plus Erlotinib
Official title: A Phase II Trial of Adjuvant Bevacizumab and Erlotinib in Patients at High Risk for Early Relapse Following Radical Prostatectomy for Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: Translational Oncology Research International
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2005-09-20
Enrollment: 23
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: To Evaluate the Efficacy of Bevacizumab Plus Erlotinib
timeFrame: Determined by time to tumor recurrence, as measured by rising prostate specific antigen (PSA) after radical prostatectomy.
measure: Time to Tumor Recurrence
timeFrame: Tumor progression assessed every 3 months during Follow-up Period for a maximum of 3 years after administration of first study treatment
Secondary outcomes:
measure: Time to Tumor Progression.
timeFrame: Tumor progression assessed every 3 months during Follow-up Period for a maximum of 3 years after administration of first study treatment
measure: Overall Survival
timeFrame: Survival status was assessed every 3 months after completion of study treatment for a maximum of 3 years after administration of first study treatment
Other outcomes:
Locations:
city: Alhambra
country: United States
facility: Central Hematology Oncology Medical Group, Inc.
state: California
city: Bakersfield
country: United States
facility: Comprehensive Blood and Cancer Center
state: California
city: Fullerton
country: United States
facility: Virginia K. Crosson Cancer Center
state: California
city: Long Beach
country: United States
facility: Pacific Shores Medical Group
state: California
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Northridge
country: United States
facility: North Valley Hematology/Oncology Medical Group
state: California
city: Oxnard
country: United States
facility: Ventura County Hematology-Oncology Specialists
state: California
city: Pomona
country: United States
facility: Wilshire Oncology Medical Group, Inc.
state: California
city: Redondo Beach
country: United States
facility: Cancer Care Associates Medical Group, Inc.
state: California
city: Santa Barbara
country: United States
facility: Sansum Santa Barbara Medical Foundation Clinic
state: California
city: Santa Barbara
country: United States
facility: Santa Barbara Hematology Oncology Medical Group, Inc.
state: California
city: Santa Maria
country: United States
facility: Central Coast Medical Oncology Corporation
state: California
city: Vista
country: United States
facility: San Diego Cancer Center
state: California
city: Orlando
country: United States
facility: Cancer Institute of Florida, P.A.
state: Florida
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: San Antonio
country: United States
facility: South Texas Oncology and Hematology, P.A.
state: Texas
Study officials:
affiliation: Chief Medical Officer, TORI
name: Fairooz Kabbinavar, MD
role: STUDY_CHAIR
References: