Treatment of Prostate Cancer With Adjuvant Bevacizumab Plus Erlotinib

NCT ID: NCT00203424

Last Updated: 2016-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2010-06-30

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Erlotinib + Bevacizumab

Participants received Erlotinib every day for 24 weeks and Bevacizumab every 3 weeks for a total of 8 doses

Group Type: EXPERIMENTAL

Erlotinib + Bevacizumab

Intervention Type: DRUG

Erlotinib every day for 24 weeks and Bevacizumab every 3 weeks for a total of 8 doses

Interventions

Erlotinib + Bevacizumab

Erlotinib every day for 24 weeks and Bevacizumab every 3 weeks for a total of 8 doses

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Translational Oncology Research International

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fairooz Kabbinavar, MD

Role: STUDY_CHAIR

Chief Medical Officer, TORI

Locations

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

Countries

United States

Other Identifiers

05-07-102

Identifier Type: OTHER

Identifier Source: secondary_id

TORI GU-01

Identifier Type: -

Identifier Source: org_study_id