Prostate CancerPhase 2NCT00658697
Docetaxel, Bevacizumab and Androgen Deprivation Therapy After Definitive Local Therapy for Prostate Cancer
A Phase 2 study testing Docetaxel, Bevacizumab and ADT in people with Prostate Cancer, run by Dana-Farber Cancer Institute at 3 sites in United States.
Trial summary
In this research study, we aim to evaluate the feasibility, toxicity and efficacy of early multimodality systemic therapy (a combination of docetaxe, bevacizumab, and androgen deprivation therapy(ADT) in men with biochemical recurrence (BCR) or who have a rising Prostate Specific Antigen (PSA) after treatment of their… 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?
- Docetaxel, Bevacizumab and ADT
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2008to Jun 2015
- 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
- 18 years of age or older
- History of biopsy documented prostate cancer (any Gleason score)
- Past treatment with prostatectomy with our without salvage prostate/pelvic radiation or primary radiation
- If past prostatectomy, pathologic stage no greater than T1-3, N1, M0
- PSA recurrence with PSAdt 8 months or less. There is no minimum PSA for prostatectomy patients. For patients treated with primary radiation therapy PSA should be 2.0ng/ml or greater
- No evidence of recurrent disease on exam, bone scan, CT/MRI abdomen/pelvis on CXR
Show all 14Show fewer
- Prior ADT allowed if less than 6 months and testosterone recovered to within 50 units of normal range
- ECOG Performance status of 0-1
- Absolute neutrophil count of 1,500 mm3 or greater
- Platelet Count 100,000 mm3 or greater
- Total bilirubin within normal limits
- HG 8gm/dl or greater
- Testosterone within 50 units of normal range
- No history of bleeding or thromboses within the last 12 months that required medical intervention
Who cannot join
- History of cancer within 5 years, other than prostate cancer and non-melanoma skin cancer
- Medical condition requiring concomitant corticosteroids
- Active infection
- Prior chemotherapy
- Neuropathy requiring medical therapy
- Documented local recurrence or metastatic prostate cancer
Show all 24Show fewer
- Inability to comply with study and/or follow-up procedures
- Life expectancy of less than 2 years
- Current, recent (within 4 weeks of first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored Avastin cancer study
- Inadequately controlled hypertension
- Any prior history of hypertensive crisis or hypertensive encephalopathy
- NYHA Grade II or greater congestive heart failure
- History of myocardial infarction or unstable angina within 12 months prior to study enrollment
- History of stroke or transient ischemic attack at any time
- Known CNS disease
- Significant vascular disease
- Symptomatic peripheral vascular disease
- Evidence of bleeding diathesis or coagulopathy
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of need for major surgical procedure during the course of the study
- Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to enrollment
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment
- Serious, non-healing wound, ulcer, or bone fracture
- Proteinuria at screening
- Known hypersensitivity to any component of Avastin
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Maryland - Greenebaum Cancer Center
Baltimore, Maryland, 21201
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: A Phase II Trial of Avastin, Docetaxel and Androgen Deprivation Followed by Continued Avastin and Androgen Deprivation for Men With a Rising Prostate Specific Antigen (PSA) After Local Therapy
In this research study, we aim to evaluate the feasibility, toxicity and efficacy of early multimodality systemic therapy (a combination of docetaxe, bevacizumab, and androgen deprivation therapy(ADT) in men with biochemical recurrence (BCR) or who have a rising Prostate Specific Antigen (PSA) after treatment of their prostate cancer with surgery or radiation)
Read the detailed description
A single arm phase 2 study designed to evaluate the rate of patients free from Prostate Specific Antigen (PSA) progression (TTP) one year after completing ADT for men with BCR after definitive local therapy for prostate cancer.
The null and alternative TTP rate were 41% and 60% respectively. A sample size of 42 would provide 80% power to detect the difference with a 2-sided type I error rate of 0.05.'
The primary objective was to evaluate the proportion of patients free from PSA progression after completing one year of ADT
The secondary objectives included
- PSA response (< 0.2 ng/mL and < 0.01) at completion of docetaxel/bevacizumab, at completion of ADT and one year off ADT
- Correlation of PSA response and TTP
- Toxicity
- Testosterone recovery at 6, 12 months off ADT
Treatment schedule details are as follows:
- Each treatment cycle lasts three weeks. During the first three months, participants will receive the Avastin and docetaxel on day 1 of each three-week cycle for a total of four doses of docetaxel/Avastin. Avastin and docetaxel are administered intravenously. The Avastin will continue to be given every three weeks after the docetaxel is completed for a total of 17 doses (one year) of Avastin therapy.
- Participants will receive zoladex (or lupron) on day 1 of the first cycle and then every 3 months for a total of 18 months. Zoladex is administered subcutaneously and Lupron is administered intramuscularly.
- Bicalutamide pills will be started at the completion of docetaxel chemotherapy (start of month 4) and will be taken once daily until hormone therapy is completed (total of 15 months).
- During all treatment cycles, the participant will have a physical exam and will be asked questions about their general health and specific questions about any problems they might be experiencing. Blood work will be performed every three weeks for the first three months and then every three months while on hormone therapy and during follow-up.
- After the final treatment participants will have a follow-up visit every three months for the first two years, every 4 months for the third year and every 6 months for years 4 and 5.
- Conditions
- Prostate Cancer
- Being tested
- Docetaxel, Bevacizumab, ADT, Bicalutamide
- Keywords
- Rising PSA, androgen deprivation, bevacizumab (avastin), docetaxel, lupron, zoladex, bicalutamide
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
Also called Taxotere, Docecad
Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles
BevacizumabDrug
Also called Avastin
Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles
ADTDrug
Also called Lupron or Zoladex
Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)
BicalutamideDrug
Also called Casodex, Cosudex, Calutide, Kalumid
Starting on day 84 orally once daily until hormone therapy is completed
| Study group | Role | What they receive |
|---|---|---|
| Docetaxel, Bevacizumab, and ADT | Experimental | Docetaxel:
Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles
Bevacizumab:
Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles
ADT or Luteinizing hormone-releasing hormone agonist (LHRH):
Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)
Bicalutamide:
Oral Bicalutamide on day 84 once daily (after completing docetaxel, at 3 month) at dose of 50 mg for a total 15 months (4-18 months) Receives: Drug: Docetaxel; Drug: Bevacizumab; Drug: ADT; Drug: Bicalutamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prostate-Specific Antigen (PSA) Progression at 1 Year After Completing Androgen Deprivation Therapy (ADT)
For prostatectomy patients: at least two serial rising PSA from treatment nadir and PSA > 0.2 ng/mL.
For patient receiving radiation therapy alone as primary local therapy, at least two serial rising PSA from treatment nadir and PSA >2.0 ng/mL.
Any new site of metastatic disease on imagining would be considered progression regardless of PSA value Clinical assessments (Vitals, Physical Exam, Performance Status, PSA and testosterone) were performed every 3 months starting at completion of hormone therapy until PSA progression.
Measured: participants were followed for the duration of the study, an average of 2 years
Secondary outcomes (4)
Proportion of Patients With PSA Responses at One Year After the Completion of ADT
The PSA response was defined using two cut-offs: PSA <0.2 ng/mL or PSA <0.01 ng/mL at the one year after completion of ADT.
Measured: 1 year + 3 month off last ADT injection
Time to PSA Progression (TTP)
For prostatectomy patients: at least two serial rising PSA from treatment nadir and PSA > 0.2 ng/mL. For patient receiving radiation therapy alone as primary local therapy, at least two serial rising PSA from treatment nadir and PSA > 2.0 ng/mL. Any new site of metastatic disease on imagining would be considered progression regardless of PSA value
Measured: participants were followed for the duration of the study, an average of 2 years
Testosterone Recovery
Testosterone recovery was defined as >100 or within DFCI institute normal range (240-950) at one year after the completion of ADT
Measured: 2 years
Toxicity
Treatment related adverse events were graded based on CTCAE v. 3.0.
Measured: Assessed each cycle throughout treatment form time of first dose to 30 days post-treatment, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2008 (estimated)
- Study startJun 2008
- Primary completionSep 2014
- Study completionJun 2015
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.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary-Ellen Taplin, MD, Dana-Farber Cancer Institute
- Investigators
- Mary-Ellen Taplin, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00658697
- Sponsor's protocol ID
- 08-004
- Status last verified
- Apr 2017
- First submitted
- 9 Apr 2008
- Last updated
- 25 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Avastin, Docetaxel and Androgen Deprivation Followed by Continued Avastin and Androgen Deprivation for Men With a Rising Prostate Specific Antigen (PSA) After Local Therapy
- ClinicalTrials.gov ID
- NCT00658697
- Acronym / sponsor ID
- 08-004
- Conditions
- Prostate Cancer
- Keywords
- Rising PSA, androgen deprivation, bevacizumab (avastin), docetaxel, lupron, zoladex, bicalutamide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, Beth Israel Deaconess Medical Center, Genentech, Inc.
- Study start
- Jun 2008
- Primary completion
- Sep 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 15 Apr 2008 (estimated)
- Results
- Posted 26 Aug 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this research study, we aim to evaluate the feasibility, toxicity and efficacy of early multimodality systemic therapy (a combination of docetaxe, bevacizumab, and androgen deprivation therapy(ADT) in men with biochemical recurrence (BCR) or who have a rising Prostate Specific Antigen (PSA) after treatment of their prostate cancer with surgery or radiation)
Detailed description
A single arm phase 2 study designed to evaluate the rate of patients free from Prostate Specific Antigen (PSA) progression (TTP) one year after completing ADT for men with BCR after definitive local therapy for prostate cancer.
The null and alternative TTP rate were 41% and 60% respectively. A sample size of 42 would provide 80% power to detect the difference with a 2-sided type I error rate of 0.05.'
The primary objective was to evaluate the proportion of patients free from PSA progression after completing one year of ADT
The secondary objectives included
- PSA response (< 0.2 ng/mL and < 0.01) at completion of docetaxel/bevacizumab, at completion of ADT and one year off ADT
- Correlation of PSA response and TTP
- Toxicity
- Testosterone recovery at 6, 12 months off ADT
Treatment schedule details are as follows:
- Each treatment cycle lasts three weeks. During the first three months, participants will receive the Avastin and docetaxel on day 1 of each three-week cycle for a total of four doses of docetaxel/Avastin. Avastin and docetaxel are administered intravenously. The Avastin will continue to be given every three weeks after the docetaxel is completed for a total of 17 doses (one year) of Avastin therapy.
- Participants will receive zoladex (or lupron) on day 1 of the first cycle and then every 3 months for a total of 18 months. Zoladex is administered subcutaneously and Lupron is administered intramuscularly.
- Bicalutamide pills will be started at the completion of docetaxel chemotherapy (start of month 4) and will be taken once daily until hormone therapy is completed (total of 15 months).
- During all treatment cycles, the participant will have a physical exam and will be asked questions about their general health and specific questions about any problems they might be experiencing. Blood work will be performed every three weeks for the first three months and then every three months while on hormone therapy and during follow-up.
- After the final treatment participants will have a follow-up visit every three months for the first two years, every 4 months for the third year and every 6 months for years 4 and 5.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Docetaxel, Bevacizumab, and ADT | Experimental | Drug: Docetaxel, Drug: Bevacizumab, Drug: ADT, Drug: BicalutamideDocetaxel: Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles Bevacizumab: Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles ADT or Luteinizing hormone-releasing hormone agonist (LHRH): Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months) Bicalutamide: Oral Bicalutamide on day 84 once daily (after completing docetaxel, at 3 month) at dose of 50 mg for a total 15 months (4-18 months) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 18 years of age or older
- History of biopsy documented prostate cancer (any Gleason score)
- Past treatment with prostatectomy with our without salvage prostate/pelvic radiation or primary radiation
- If past prostatectomy, pathologic stage no greater than T1-3, N1, M0
- PSA recurrence with PSAdt 8 months or less. There is no minimum PSA for prostatectomy patients. For patients treated with primary radiation therapy PSA should be 2.0ng/ml or greater
Key exclusion criteria (24 listed)
- History of cancer within 5 years, other than prostate cancer and non-melanoma skin cancer
- Medical condition requiring concomitant corticosteroids
- Active infection
- Prior chemotherapy
- Neuropathy requiring medical therapy
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 |
|---|---|---|
| DocetaxelAlso: Taxotere, DocecadIntravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles | Drug | Docetaxel, Bevacizumab, and ADT |
| BevacizumabAlso: AvastinIntravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles | Drug | Docetaxel, Bevacizumab, and ADT |
| ADTAlso: Lupron or ZoladexEither subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months) | Drug | Docetaxel, Bevacizumab, and ADT |
| BicalutamideAlso: Casodex, Cosudex, Calutide, KalumidStarting on day 84 orally once daily until hormone therapy is completed | Drug | Docetaxel, Bevacizumab, and ADT |
Primary outcome
Prostate-Specific Antigen (PSA) Progression at 1 Year After Completing Androgen Deprivation Therapy (ADT)
Time frame: participants were followed for the duration of the study, an average of 2 years
For prostatectomy patients: at least two serial rising PSA from treatment nadir and PSA > 0.2 ng/mL. For patient receiving radiation therapy alone as primary local therapy, at least two serial rising PSA from treatment nadir and PSA >2.0 ng/mL. Any new site of metastatic disease on imagining would be considered progression regardless of PSA value Clinical assessments (Vitals, Physical Exam, Performance Status, PSA and testosterone) were performed every 3 months starting at completion of hormone therapy until PSA progression.
4 secondary outcomes
Proportion of Patients With PSA Responses at One Year After the Completion of ADT
Time frame: 1 year + 3 month off last ADT injection
Time to PSA Progression (TTP)
Time frame: participants were followed for the duration of the study, an average of 2 years
Testosterone Recovery
Time frame: 2 years
Toxicity
Time frame: Assessed each cycle throughout treatment form time of first dose to 30 days post-treatment, up to 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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.
Mary-Ellen Taplin, MD principal investigator
Dana-Farber Cancer Institute
3 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 Docetaxel, Bevacizumab and ADT in people with Prostate Cancer, run by Dana-Farber Cancer Institute at 3 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 14 inclusion and 24 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 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 26 Aug 2015). 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?
Prostate-Specific Antigen (PSA) Progression at 1 Year After Completing Androgen Deprivation Therapy (ADT) (time frame: participants were followed for the duration of the study, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 May 2017.