Prostate Cancer
Conditions
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.
Interventions
DRUGErlotinib + Bevacizumab
Erlotinib every day for 24 weeks and Bevacizumab every 3 weeks for a total of 8 doses
Sponsors
Genentech, Inc.
Translational Oncology Research International
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | Measured once for participants who experienced tumor recurrence per protocol. Imaging done to measure tumor progression only after documented tumor recurrence |
| 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 | — |
Countries
United States
Participant flow
Recruitment details
Dates of recruitment period: 6/23/2005 - 03/10/2009 Types of location: Academic medical clinics and community medical clinics.
Pre-assignment details
There are no pre-assignment details to describe.
Participants by arm
| Arm | Count |
|---|---|
| Erlotinib + Bevacizumab Participants that entered treatment period. | 22 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Follow-up Period | Lost to Follow-up | 1 |
| Follow-up Period | progressive disease | 4 |
| Follow-up Period | Withdrawal by Subject | 1 |
| Treatment Period | Adverse Event | 5 |
| Treatment Period | progressive disease | 2 |
| Treatment Period | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Erlotinib + Bevacizumab |
|---|---|
| Age, Continuous | 67 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 20 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 22 / 22 |
| serious Total, serious adverse events | 1 / 22 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bevacizumab+Erlotinib | Time to Tumor Recurrence | 285 days |
Primary
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.
Population: Of the 23 subjects registered for treatment, 19 were analysed for efficacy, 4 subjects were excluded from analysis because of withdrawal of subjects prior to first tumor assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bevacizumab+Erlotinib | To Evaluate the Efficacy of Bevacizumab Plus Erlotinib | completed study without tumor progression | 9 participants |
| Bevacizumab+Erlotinib | To Evaluate the Efficacy of Bevacizumab Plus Erlotinib | lost to follow-up unaffected by tumor recurrence | 1 participants |
| Bevacizumab+Erlotinib | To Evaluate the Efficacy of Bevacizumab Plus Erlotinib | withdrawal by subjects unaffected by recurrence | 2 participants |
| Bevacizumab+Erlotinib | To Evaluate the Efficacy of Bevacizumab Plus Erlotinib | affected by tumor recurrence | 7 participants |
Secondary
Overall Survival
Time frame: Survival status was assessed every 3 months after completion of study treatment for a maximum of 3 years after administration of first study treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bevacizumab+Erlotinib | Overall Survival | Deceased | 0 participants |
| Bevacizumab+Erlotinib | Overall Survival | Alive | 15 participants |
| Bevacizumab+Erlotinib | Overall Survival | Lost to Follow-up | 1 participants |
| Bevacizumab+Erlotinib | Overall Survival | Withdrawal by subject | 6 participants |
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
Time frame: Tumor progression assessed every 3 months during Follow-up Period for a maximum of 3 years after administration of first study treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bevacizumab+Erlotinib | Time to Tumor Progression. | 314 days |