Treatment of Prostate Cancer With Adjuvant Bevacizumab Plus Erlotinib

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00203424
• Other study ID #: TORI GU-01
• Secondary ID: 05-07-102
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: January 28, 2016
• Start date: January 2006

Study information

• Verified date: May 2011
• Source: Translational Oncology Research International
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Erlotinib + Bevacizumab
Erlotinib every day for 24 weeks and Bevacizumab every 3 weeks for a total of 8 doses

Locations

Country	Name	City	State
United States	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	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada
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	Cancer Institute of Florida, P.A.	Orlando	Florida
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	South Texas Oncology and Hematology, P.A.	San Antonio	Texas
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

Sponsors (2)

Lead Sponsor	Collaborator
Translational Oncology Research International	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To Evaluate the Efficacy of Bevacizumab Plus Erlotinib		Determined by time to tumor recurrence, as measured by rising prostate specific antigen (PSA) after radical prostatectomy.	Yes
Primary	Time to Tumor Recurrence		Tumor progression assessed every 3 months during Follow-up Period for a maximum of 3 years after administration of first study treatment	No
Secondary	Time to Tumor Progression.	Measured once for participants who experienced tumor recurrence per protocol. Imaging done to measure tumor progression only after documented tumor recurrence	Tumor progression assessed every 3 months during Follow-up Period for a maximum of 3 years after administration of first study treatment	No
Secondary	Overall Survival		Survival status was assessed every 3 months after completion of study treatment for a maximum of 3 years after administration of first study treatment	No