A Phase II Trial of Adjuvant Bevacizumab and Erlotinib in Patients at High Risk for Early Relapse Following Radical Prostatectomy for Prostate Cancer

Translational Oncology Research International16 sites in 1 country23 target enrollmentJanuary 2006

ConditionsProstate Cancer

InterventionsErlotinib + Bevacizumab

DrugsErlotinib + Bevacizumab

Overview

Phase: Phase 2
Intervention: Erlotinib + Bevacizumab
Conditions: Prostate Cancer
Sponsor: Translational Oncology Research International
Enrollment: 23
Locations: 16
Primary Endpoint: To Evaluate the Efficacy of Bevacizumab Plus Erlotinib
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2006

End Date

June 2010

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

Translational Oncology Research International

Responsible Party

Sponsor

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
•Current, recent (within the 4 weeks preceding Day 0), or planned participation in another experimental drug study

Arms & Interventions

Erlotinib + Bevacizumab

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

Intervention: Erlotinib + Bevacizumab

Outcomes

Primary Outcomes

To Evaluate the Efficacy of Bevacizumab Plus Erlotinib

Time Frame: Determined by time to tumor recurrence, as measured by rising prostate specific antigen (PSA) after radical prostatectomy.

Time to Tumor Recurrence

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

Secondary Outcomes

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)
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)