Prostate CancerPhase 2NCT00203424

Treatment of Prostate Cancer With Adjuvant Bevacizumab Plus Erlotinib

A Phase 2 study testing Erlotinib + Bevacizumab in people with Prostate Cancer, run by Translational Oncology Research International at 16 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Prostate Cancer
What is being tested?: Erlotinib + Bevacizumab
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 23 participants
Where: 16 sitesUnited States
Study dates: Jan 2006to Jun 2010
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Show all 16Show fewer

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

Trial locations and contacts

16 sites in 1 country.

City, postcode or hospital

16 sites in 1 country

United States16 sites

Central Hematology Oncology Medical Group, Inc.
Alhambra, California, 91801
Comprehensive Blood and Cancer Center
Bakersfield, California, 93309
Virginia K. Crosson Cancer Center
Fullerton, California, 92835
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89109
Pacific Shores Medical Group
Long Beach, California, 90813
UCLA Medical Center
Los Angeles, California, 90095
North Valley Hematology/Oncology Medical Group
Northridge, California, 91328
Cancer Institute of Florida, P.A.
Orlando, Florida, 32804
Ventura County Hematology-Oncology Specialists
Oxnard, California, 93030
Wilshire Oncology Medical Group, Inc.
Pomona, California, 91767
Cancer Care Associates Medical Group, Inc.
Redondo Beach, California, 90277
South Texas Oncology and Hematology, P.A.
San Antonio, Texas, 78207
Sansum Santa Barbara Medical Foundation Clinic
Santa Barbara, California, 93105
Santa Barbara Hematology Oncology Medical Group, Inc.
Santa Barbara, California, 93105
Central Coast Medical Oncology Corporation
Santa Maria, California, 93454
San Diego Cancer Center
Vista, California, 92081

Other trials in United States

About this study

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

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

Read the 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
Being tested: Erlotinib + Bevacizumab
Medical subject headings: Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT00203424
Study group	Role	What they receive
Erlotinib + Bevacizumab	Experimental	Participants received Erlotinib every day for 24 weeks and Bevacizumab every 3 weeks for a total of 8 doses Receives: Drug: Erlotinib + Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

To Evaluate the Efficacy of Bevacizumab Plus Erlotinib
Measured: Determined by time to tumor recurrence, as measured by rising prostate specific antigen (PSA) after radical prostatectomy.
Time to Tumor Recurrence
Measured: 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.
Measured once for participants who experienced tumor recurrence per protocol. Imaging done to measure tumor progression only after documented tumor recurrence
Measured: Tumor progression assessed every 3 months during Follow-up Period for a maximum of 3 years after administration of first study treatment
Overall Survival
Measured: Survival status was assessed every 3 months after completion of study treatment for a maximum of 3 years after administration of first study treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2006Jun 2010

First posted20 Sep 2005 (estimated)
Study startJan 2006
Primary completionFeb 2009
Study completionJun 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Prostate CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00203424
Sponsor's protocol ID: TORI GU-01
Other IDs: 05-07-102
Status last verified: Feb 2016
First submitted: 13 Sep 2005
Last updated: 25 Mar 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence

All Prostate Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00203424
Acronym / sponsor ID: TORI GU-01
Conditions: Prostate Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 23 participants (actual)
Lead sponsor: Translational Oncology Research InternationalUniversity, hospital or other
Collaborators: Genentech, Inc.
Study start: Jan 2006
Primary completion: Feb 2009 (actual)
Study completion: Jun 2010 (actual)
First posted: 20 Sep 2005 (estimated)
Results: Posted 9 May 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Erlotinib + Bevacizumab	Experimental	Drug: Erlotinib + BevacizumabParticipants received Erlotinib every day for 24 weeks and Bevacizumab every 3 weeks for a total of 8 doses

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (16 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Erlotinib + BevacizumabErlotinib every day for 24 weeks and Bevacizumab every 3 weeks for a total of 8 doses	Drug	Erlotinib + Bevacizumab

Primary outcome

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

2 secondary outcomes

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

Results and safety

Results posted to the registry on 9 May 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Erlotinib + Bevacizumab	22	11

Primary outcome: 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.. Number. Unit: participants

Measure	Bevacizumab+Erlotinib n = 19
completed study without tumor progression	9
lost to follow-up unaffected by tumor recurrence	1
withdrawal by subjects unaffected by recurrence	2
affected by tumor recurrence	7

Population analysed: 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.

Primary outcome: 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. Mean (Full Range). Unit: days

Measure	Bevacizumab+Erlotinib n = 7
Value	285 (42 to 835)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event (AE)data collected between 11/30/2005 and 1/26/2011. Therefore AE reporting period is 5.16 years or 5 years and 2 months, approximately.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Erlotinib + Bevacizumab	1 of 22 (4.5%)	22 of 22 (100%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Prostate Cancer

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Fairooz Kabbinavar, MD study chair

Chief Medical Officer, TORI

16 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Erlotinib + Bevacizumab in people with Prostate Cancer, run by Translational Oncology Research International at 16 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 May 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00203424.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2016.