- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00574769
Safety Study & Effectiveness of Docetaxel With RAD001 and Bevacizumab in Men With Advanced Prostate Cancer
April 9, 2017 updated by: University of Southern California
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
27
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Beverly Hills, California, United States, 90211
- Westside Prostate Cancer Center, University of Southern California
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Los Angeles, California, United States, 90033
- USC/Norris Comprehensive Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 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)
- 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.)
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
After the last patient in the cohort has completed at least two cycles of RAD001/docetaxel/bevacizumab
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
overall survival
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Mitchell E Gross, MD, Ph.D, University of Southern California
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 17, 2010
Primary Completion (Actual)
February 17, 2016
Study Completion (Actual)
February 17, 2017
Study Registration Dates
First Submitted
December 14, 2007
First Submitted That Met QC Criteria
December 14, 2007
First Posted (Estimate)
December 17, 2007
Study Record Updates
Last Update Posted (Actual)
April 11, 2017
Last Update Submitted That Met QC Criteria
April 9, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Male
- Prostatic Diseases
- Prostatic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Docetaxel
- Bevacizumab
- Everolimus
Other Study ID Numbers
- 4P-09-4
- AVF3955s
- CRAD001CUS2468
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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