Treatment of Prostate Cancer With Adjuvant Bevacizumab Plus Erlotinib

NCT00203424 | Completed Phase 2 Results DMC

• 2 other identifiers: TORI GU-0105-07-102
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 16

Brief Summary

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

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• 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.

• 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

Secondary Outcomes (2)

• Time to Tumor Progression.

  Tumor progression assessed every 3 months during Follow-up Period for a maximum of 3 years after administration of first study treatment

• 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

Study Arms (1)

Erlotinib + Bevacizumab

EXPERIMENTAL

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

Drug: Erlotinib + Bevacizumab

Interventions

Erlotinib + Bevacizumab DRUG

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

Erlotinib + Bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Translational Oncology Research International: lead
• Genentech, Inc.: collaborator

Study Sites (16)

Central Hematology Oncology Medical Group, Inc.

Alhambra, California, 91801, United States

Location

Comprehensive Blood and Cancer Center

Bakersfield, California, 93309, United States

Location

Virginia K. Crosson Cancer Center

Fullerton, California, 92835, United States

Location

Pacific Shores Medical Group

Long Beach, California, 90813, United States

Location

UCLA Medical Center

Los Angeles, California, 90095, United States

Location

North Valley Hematology/Oncology Medical Group

Northridge, California, 91328, United States

Location

Ventura County Hematology-Oncology Specialists

Oxnard, California, 93030, United States

Location

Wilshire Oncology Medical Group, Inc.

Pomona, California, 91767, United States

Location

Cancer Care Associates Medical Group, Inc.

Redondo Beach, California, 90277, United States

Location

Sansum Santa Barbara Medical Foundation Clinic

Santa Barbara, California, 93105, United States

Location

Santa Barbara Hematology Oncology Medical Group, Inc.

Santa Barbara, California, 93105, United States

Location

Central Coast Medical Oncology Corporation

Santa Maria, California, 93454, United States

Location

San Diego Cancer Center

Vista, California, 92081, United States

Location

Cancer Institute of Florida, P.A.

Orlando, Florida, 32804, United States

Location

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89109, United States

Location

South Texas Oncology and Hematology, P.A.

San Antonio, Texas, 78207, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Erlotinib Hydrochloride; Bevacizumab

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

This was a small study with only 22 participants who received study treatment. With such a small sample size the study doesnt have the statistcical power to make categorical assessments or statements.

Results Point of Contact

• Title: Dr. Fairooz F. Kabbinavar, Chief Medical Officer
• Organization: Translational Oncology Research International

FKabbina@mednet.ucla.edu

310-824-1934

Study Officials

• Fairooz Kabbinavar, MD

  Chief Medical Officer, TORI

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: January 1, 2006
• Primary Completion: February 1, 2009
• Study Completion: June 1, 2010
• Last Updated: March 25, 2016
• Results First Posted: May 9, 2011

Record last verified: 2016-02

Locations

US (16)