Prostate CancerPhase 1/2NCT00574769
Safety Study & Effectiveness of Docetaxel With RAD001 and Bevacizumab in Men With Advanced Prostate Cancer
A Phase 1/2 study testing RAD001, Docetaxel, Bevacizumab in people with Prostate Cancer, run by University of Southern California at 2 sites in United States.
Trial summary
Prostate cancer is a common and important health issue. Although effective treatment is often available for localized disease, metastatic prostate cancer remains incurable. The initial treatment for metastatic prostate cancer often includes medical or surgical treatments that deprive the tumor of male hormones… 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?
- RAD001, Docetaxel, Bevacizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Feb 2010to 17 Feb 2017
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
- Age ≥ 18 years.
- Signed informed consent
- ECOG performance status: 0-2
- Histologically documented adenocarcinoma of the prostate
- Progressive disease despite androgen deprivation therapy. Progressive disease is defined as any one of the following:
- Measurable Disease: Objective evidence of increase > 20% in the sum of the longest diameters of target lesions from the time of maximal regression or the appearance of one or more new lesions (Modified RECIST Criteria)
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- Bone Scan Progression: Appearance of one or more new lesions on bone scan attributable to prostate cancer
- PSA Progression: An elevated PSA (≥ 5 ng/ml) which has risen serially from baseline on two occasions each at least one week apart
- At least 4 weeks since any other hormonal therapy. Flutamide and megestrol acetate (any dose) must be discontinued at least 4 weeks prior to initiating treatment. Bicalutamide or nilutamide must be discontinued at least 6 weeks prior to initiating treatment. If improvement following antiandrogen withdrawal is noted, progression must be established using the criteria above. Androgen suppression should be continued
- ≥ 4 weeks since major surgery and fully recovered
- ≥ 8 weeks since high risk surgery and fully recovered
- ≥ 4 weeks since any prior radiation and fully recovered
- ≥ 6 weeks since the last dose of bone targeted radiopharmaceutical
- Men of child-bearing potential are required to use an effective means of contraception
- Required Initial Laboratory Values:
- ANC ≥ 1500/µL
- Platelet count ≥ 100,000/µL
- Creatinine ≤ 1.5 x ULN
- Bilirubin ≤ 1.5 x ULN
- AST ≤ 1.5 x ULN
- Urine protein to creatinine ratio < 1.0
- Serum Testosterone ≤ 50 ng/dL (For patients who have not had bilateral orchiectomy.)
Who cannot join
- Prior treatment with cytotoxic chemotherapy for metastatic disease
- Prior treatment with anti-angiogenic agents, including thalidomide and bevacizumab
- Prior treatment with any investigational drug within 4 weeks of initiating treatment
- Prior treatment with an mTor inhibitor
- Chronic treatment with systemic steroids or another immunosuppressive agent
- Known history of HIV seropositivity
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- Known brain metastases (brain imaging is not required)
- Congestive heart failure
- Uncontrolled hypertension. Patients with history of hypertension must be well controlled (< 150/100) on a regimen of anti-hypertensive therapy
- Any prior history of hypertensive crisis or hypertensive encephalopathy
- Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment
- Active bleeding diathesis or on oral anti-vitamin K medications (except low dose coumarin)
- Arterial thrombotic events, including transient ischemic attack (TIA), cerebrovascular accident (CVA), at any time
- History of unstable angina or angina requiring surgical or medical intervention in the past 12 months, or myocardial infarction (MI)
- Patients with clinically significant peripheral artery disease or any other arterial thrombotic event
- Significant vascular disease
- Other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study
- Proteinuria at screening as demonstrated by either
- Urine protein:creatinine (UPC) ratio ≥ 1.0 OR
- Urine dipstick for proteinuria ≥ 2+
- Serious or non-healing wound, ulcer or bone fracture
- Peripheral neuropathy ≥ grade 2
- Known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
- Herbal medications and food supplements must be discontinued before registration. Patients may continue on daily vitamins and calcium supplements
- History of noncompliance to medical regimens
- Unwilling to or unable to comply with the protocol
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Westside Prostate Cancer Center, University of Southern California
Beverly Hills, California, 90211
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: Phase Ib/II Evaluation of RAD001 With Docetaxel and Bevacizumab in Patients With Metastatic Androgen Independent Prostate Cancer
Prostate cancer is a common and important health issue. Although effective treatment is often available for localized disease, metastatic prostate cancer remains incurable. The initial treatment for metastatic prostate cancer often includes medical or surgical treatments that deprive the tumor of male hormones (androgens) required for growth. Although this treatment is successful for many patients, the cancer may eventually return in others. Recurrent prostate cancer may be treated with additional hormonal agents, but these agents usually do not result in long-term control of the disease. Eventually most patients with recurrent prostate cancer progress to a state where the cancer grows despite very low level of circulating male hormones known as androgen independent prostate cancer (AIPC).
Read the detailed description
Patients will undergo a screening procedure to determine eligibility of trial. During the treatment period, the patient will be given docetaxel/bevacizumab on day 1 followed by RAD001 continuously on days 2-21 and this is called a treatment cycle. Patients will be able to continue to receive multiple treatment courses as long as the cancer does not get worse and the person does not develop other problems that would prevent him from staying in the study. The final part of the research is the study completion period which includes an end of treatment visit and subsequent follow-up visits. These visits take place whenever the research medication is stopped, even if it is stopped early. For the patient's safety, he/she should at least complete the end of treatment visit.
- Conditions
- Prostate Cancer
- Being tested
- RAD001, Docetaxel, Bevacizumab
- Keywords
- RAD001, mTOR inhibition, docetaxel, bevacizumab, adenocarcinoma of the prostate, recurrent prostate cancer, stage IV prostate cancer, prostate cancer, Metastatic, androgen independent prostate cancer
- Medical subject headings
- Prostatic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAD001, Docetaxel, BevacizumabDrug
Also called everolimus, Avastin, Taxotere
RAD001 oral, 2.5 mg daily RAD001 oral, 5mg daily
Bevacizumab infusion (IV), 15 mg/kg every 21 days
Docetaxel infusion (IV), 75 mg/m^2 every 21 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: RAD001, Docetaxel, Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish a maximal tolerated or optimal biologic dose of RAD001 in combination with docetaxel/bevacizumab
Measured: After the last patient in the cohort has completed at least two cycles of RAD001/docetaxel/bevacizumab
Secondary outcomes (1)
Evaluate the efficacy of RAD001 in combination with docetaxel/bevacizumab as determined by best overall response and progression-free survival in patients with advanced prostate cancer.
Measured: overall survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2007 (estimated)
- Study start17 Feb 2010
- Primary completion17 Feb 2016
- Study completion17 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis, Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Mitchell E Gross, MD, Ph.D, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00574769
- Sponsor's protocol ID
- 4P-09-4
- Other IDs
- AVF3955s, CRAD001CUS2468
- Status last verified
- Apr 2017
- First submitted
- 14 Dec 2007
- Last updated
- 11 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib/II Evaluation of RAD001 With Docetaxel and Bevacizumab in Patients With Metastatic Androgen Independent Prostate Cancer
- ClinicalTrials.gov ID
- NCT00574769
- Acronym / sponsor ID
- 4P-09-4
- Conditions
- Prostate Cancer
- Keywords
- RAD001, mTOR inhibition, docetaxel, bevacizumab, adenocarcinoma of the prostate, recurrent prostate cancer, stage IV prostate cancer, prostate cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- Novartis, Genentech, Inc.
- Study start
- 17 Feb 2010 (actual)
- Primary completion
- 17 Feb 2016 (actual)
- Study completion
- 17 Feb 2017 (actual)
- First posted
- 17 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prostate cancer is a common and important health issue. Although effective treatment is often available for localized disease, metastatic prostate cancer remains incurable. The initial treatment for metastatic prostate cancer often includes medical or surgical treatments that deprive the tumor of male hormones (androgens) required for growth. Although this treatment is successful for many patients, the cancer may eventually return in others. Recurrent prostate cancer may be treated with additional hormonal agents, but these agents usually do not result in long-term control of the disease. Eventually most patients with recurrent prostate cancer progress to a state where the cancer grows despite very low level of circulating male hormones known as androgen independent prostate cancer (AIPC).
Detailed description
Patients will undergo a screening procedure to determine eligibility of trial. During the treatment period, the patient will be given docetaxel/bevacizumab on day 1 followed by RAD001 continuously on days 2-21 and this is called a treatment cycle. Patients will be able to continue to receive multiple treatment courses as long as the cancer does not get worse and the person does not develop other problems that would prevent him from staying in the study. The final part of the research is the study completion period which includes an end of treatment visit and subsequent follow-up visits. These visits take place whenever the research medication is stopped, even if it is stopped early. For the patient's safety, he/she should at least complete the end of treatment visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: RAD001, Docetaxel, Bevacizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Age ≥ 18 years.
- Signed informed consent
- ECOG performance status: 0-2
- Histologically documented adenocarcinoma of the prostate
- Progressive disease despite androgen deprivation therapy. Progressive disease is defined as any one of the following:
Key exclusion criteria (27 listed)
- Prior treatment with cytotoxic chemotherapy for metastatic disease
- Prior treatment with anti-angiogenic agents, including thalidomide and bevacizumab
- Prior treatment with any investigational drug within 4 weeks of initiating treatment
- Prior treatment with an mTor inhibitor
- Chronic treatment with systemic steroids or another immunosuppressive agent
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 |
|---|---|---|
| RAD001, Docetaxel, BevacizumabAlso: everolimus, Avastin, TaxotereRAD001 oral, 2.5 mg daily RAD001 oral, 5mg daily Bevacizumab infusion (IV), 15 mg/kg every 21 days Docetaxel infusion (IV), 75 mg/m^2 every 21 days | Drug | 1 |
Primary outcome
Establish a maximal tolerated or optimal biologic dose of RAD001 in combination with docetaxel/bevacizumab
Time frame: After the last patient in the cohort has completed at least two cycles of RAD001/docetaxel/bevacizumab
1 secondary outcome
Evaluate the efficacy of RAD001 in combination with docetaxel/bevacizumab as determined by best overall response and progression-free survival in patients with advanced prostate cancer.
Time frame: overall survival
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
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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.
Mitchell E Gross, MD, Ph.D principal investigator
University of Southern California
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing RAD001, Docetaxel, Bevacizumab in people with Prostate Cancer, run by University of Southern California at 2 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 22 inclusion and 27 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 11 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Establish a maximal tolerated or optimal biologic dose of RAD001 in combination with docetaxel/bevacizumab (time frame: After the last patient in the cohort has completed at least two cycles of RAD001/docetaxel/bevacizumab). 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 11 Apr 2017.