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Phase II Study of AZD2171 in Patients With Metastatic Androgen-Independent Prostate Cancer
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outcomes Outline Trial Contact Information Related Information Registry Information
Alternate Title
AZD2171 in Treating Patients With Metastatic Androgen-Independent Prostate Cancer
Basic Trial Information
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Phase
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Type
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Status
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Age
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Sponsor
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Protocol IDs
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Phase II
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Biomarker/Laboratory analysis, Treatment
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Active
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18 and over
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NCI
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NCI-07-C-0059 NCI-P6964, 7395, NCT00436956
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Special Category:
NIH Clinical Center trial, NCI Web site featured trial Objectives Primary - Determine if treatment with AZD2171 is associated with a 30% 6-month probability of progression-free survival in patients with metastatic androgen-independent prostate cancer.
Secondary - Determine the overall response rate and overall survival of patients treated with this regimen.
- Assess survival, from the time of prostate-specific antigen (PSA) progression, in the absence of radiological or clinical progression.
- Assess the biologic effect of this regimen in these patients.
- Determine the pharmacokinetics of this regimen in these patients.
- Evaluate the PSA response rate in patients treated with this regimen.
Entry Criteria Disease Characteristics:
- Histologically confirmed prostate cancer
- Metastatic disease
- 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
Prior/Concurrent Therapy:
- See Disease Characteristics
- Recovered from
prior therapy, including surgery
- At least 4 weeks since prior agents not approved by the FDA
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C),
radiotherapy, or major surgery
- Concurrent bisphosphonates allowed for patients with known bone metastases
- No concurrent grapefruit juice
- No concurrent antiretroviral therapy for HIV-positive patients
- No other concurrent anticancer agents or therapies
Patient Characteristics:
- ECOG performance status (PS) 0-2 Karnofsky PS 60-100%
- Life expectancy > 3 months
- Absolute neutrophil count ≥ 1,500/mm3
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Platelet count ≥ 100,000/mm3
- Hemoglobin ≥ 8 g/dL
- Bilirubin ≤ 1.5 times upper limit of normal (ULN) (unless due to clinical Gilbert’s syndrome)
- AST and ALT ≤ 2.5 times ULN
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Creatinine ≤ 1.5 times ULN OR creatinine clearance > 40 mL/min
- Urine protein ≤ +1 on two consecutive dipsticks taken no less than 1 week apart
- Blood pressure < 140/90 mm Hg
- Fertile patients must use effective contraception during and for 3 months after completion of study participation
- No other invasive malignancies within the past 5 years except nonmelanoma skin cancer or noninvasive bladder cancer
- No mean QTc > 470 msec (with Bazett’s correction)
- No history of familial long QT syndrome
- 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
Expected Enrollment 37A total of 37 patients will be accrued for this study. Outcomes Primary Outcome(s)6-month progression-free survival
Secondary Outcome(s)Prostate-specific antigen Pharmacokinetics
Outline Patients receive oral AZD2171 once daily on days 1-28. Courses repeat 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. Samples are evaluated for pharmacokinetics and tumor and gene expression alterations. Patients undergo a dynamic contrast-enhanced MRI at baseline and on days 2, 28, and 56 for the evaluation of tumor vascularity. After the completion of study treatment, patients are followed periodically.
Trial Contact Information
Trial Lead Organizations NCI - Center for Cancer Research-Medical Oncology | | | William Figg, PharmD, Protocol chair | | | | William Dahut, MD, Principal investigator | | | | Marcia Mulquin, RN, Study coordinator | | | | Trial Sites
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U.S.A. |
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Maryland |
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Bethesda |
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| | | | | | | | Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office |
| | Clinical Trials Office - Warren Grant Magnusen Clinical Center - NCI Clinical Trials Referral Office | |
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Related Information Featured trial article
Registry Information | | Official Title | | A Phase II Study of AZD2171 in Metastatic Androgen Independent Prostate Cancer | | Trial Start Date | | 2007-05-07 | | Trial Completion Date | | 2008-08-09 (estimated) | | Registered in ClinicalTrials.gov | | NCT00436956 | | Date Submitted to PDQ | | 2006-12-27 | | Information Last Verified | | 2008-08-29 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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