A Phase II Study of AZD2171 in Metastatic Androgen-Independent Prostate Cancer
Protocol # 07-C-0059
- Why is this trial important?
- Who is eligible for this trial?
- What types of drugs or therapies are being used?
- What is the treatment plan?
- What is the frequency and duration of the visits?
- What are the costs?
- Who is the Principal Investigator?
- Where is this trial taking place?
- Who are the contacts for this trial?
- Where can additional information be found?
Why is this trial important?
There are no proven therapies in patients who have progressed after docetaxel chemotherapy for metastatic prostate cancer. Angiogenesis has been shown to play an important role in prostate cancer progression. VEGF is implicated in tumor blood vessel formation and in disease progression. Anti-angiogenic therapy directed at the VEGF signaling pathway may be helpful in advanced prostate cancer. Cediranib, AZD2171, an orally available small molecule, is a potent inhibitor of receptor tyrosine kinases that influence VEGF and has been shown to inhibit VEGF signaling. This trial will look at the anti-tumor activity of cediranib in patients with metastatic prostate cancer post docetaxel.
Who is eligible for this trial? (PDQ)
- Histologically confirmed metastatic prostate cancer; progressive, androgen-independent disease:
- Radiographic evidence of disease that has continued to progress despite hormonal agents
- Patients on flutamide must have disease progression at least 4 weeks after withdrawal
- Patients on bicalutamide or nilutamide must have disease progression at least 6 weeks after withdrawal
- Progressive disease requires that a measurable lesion is expanding, new lesions have appeared, and/or that prostate-specific antigen is continuing to rise on successive measurements
- Must have received prior docetaxel for androgen-independent prostate cancer
- Concurrent gonadotropin-releasing hormone agonists or antagonists required for patients without bilateral surgical castration
- No known brain metastases
- ECOG 0–2
- Absolute neutrophil count ≥ 1,500/mm3; platelet count ≥ 100,000/mm3; hemoglobin ≥ 8 g/dL
- Bilirubin normal (unless due to clinical Gilbert’s syndrome); AST and ALT ≤ 2.5 times upper limit of normal
- Creatinine OR creatinine clearance normal; urine protein ≤ +1 on two consecutive dipsticks taken no less than 1 week apart
- Blood pressure < 140/90 mm Hg
- No concurrent antiretroviral therapy for HIV-positive patients
- No uncontrolled intercurrent illness including, but not limited to, any of the following: hypertension, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric illness or social situation that would limit compliance
What types of drugs or therapies are being used?
Cediranib, oral antiangiogenic, receptor tyrosine kinase inhibitor is given in combination with prednisone an oral steroid used in an attempt to improve Cediranib tolerability.
What is the treatment plan? (PDQ)
- Patients receive oral AZD2171 in addition to prednisone once daily on Days 1–28
- Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
- Blood samples are collected at baseline and periodically during Course 1 of study therapy
- Patients undergo a dynamic contrast-enhanced MRI at baseline and on Days 2, 28, 56, after Cycle 4, and then every four cycles
What is the frequency and duration of the visits?
At the outset of the study patients will be hospitalized for 3 days to complete research studies to determine drug metabolism. Cediranib will be taken as an outpatient basis and patients will return to the clinic every 28 days for an evaluation. This follow up assessment will be completed in 1 day as an outpatient.
What are the costs?
There is no charge for medical care received at the National Institutes of Health (NIH) Clinical Center. Patients will be responsible for travel costs for their initial screening visits. In most cases, once patients are enrolled in a trial, the National Cancer Institute (NCI) will pay the transportation costs for all subsequent trial-related visits for patients who do not live in the local area. In addition, these patients will receive a small per diem to help offset the costs of meals and lodging if they are being treated as outpatients.
It will be important to maintain your current insurance plan to cover all medical care that is provided away from the NIH Clinical Center.
No U.S. citizen or permanent U.S. resident residing in the U.S. who otherwise meets the eligibility requirements will be denied enrollment in clinical research protocols because of their inability to pay the costs of travel and subsistence.
Who is the Principal Investigator?
Dr. Dahut received his M.D. from Georgetown University in Washington, D.C. He completed clinical training in internal medicine at the National Naval Medical Center in Bethesda, Md., followed by training in hematology and medical oncology at the Bethesda Naval Hospital and the Medicine Branch of NCI. Dr. Dahut worked as an attending physician in the NCI-Navy Medical Oncology Branch until 1995. He then joined the faculty of the Lombardi Cancer Center at Georgetown University before returning to the former NCI Medicine Branch in 1998 as head of the prostate cancer clinic. Dr Dahut is now Chief of the GU/GYN Clinical Research Section in the Medical Oncology Branch. Dr. Dahut’s primary research interest has been in the development of novel therapeutic strategies for the treatment of adenocarcinoma of the prostate.
Where is this trial taking place?
NIH Clinical Center
National Institutes of Health
NCI Medical Oncology Branch and Affiliates
10 Center Drive
Bethesda, Maryland 20892
Who are the contacts for this trial?
William Dahut, M.D.
Principal Investigator
Phone: 301-435-8183
dahutw@mail.nih.gov
Referrals:
Laura D. Otten, R.N., B.S.N., O.C.N.
Medical Oncology Referral Coordinator
Phone: 301-451-1228
1-866-611-6310 (Toll free)
Fax: 301-480-0919
ottenl@mail.nih.gov
Marcia L. Mulquin, R.N., B.S.N.
Research Nurse
Phone: 301-435-5613
Fax: 301-402-7901
mmulquin@mail.nih.gov
Where can additional information be found?
Back to Top
