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Phase II Study of Cilengitide in Patients With Non-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
Cilengitide in Treating Patients With 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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Treatment
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Closed
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18 and over
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NCI
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CCUM-2004-045 6735, NCI-6735, NCT00121238
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Special Category:
NCI Web site featured trial Objectives Primary - Determine the prostate-specific antigen (PSA) response rate in patients with non-metastatic androgen-independent prostate cancer treated with cilengitide.
Secondary - Determine the safety of this drug in these patients.
- Determine the change in slope of PSA in patients treated with this drug.
- Determine the duration of response, time to progression, and survival of patients treated with this drug.
Entry Criteria Disease Characteristics:
Prior/Concurrent Therapy:
Biologic therapy Chemotherapy Endocrine therapy - See Disease Characteristics
- At least 4 weeks since prior flutamide
- At least 6 weeks since prior bicalutamide or nilutamide
- At least 4 weeks since any other prior therapy intended to treat the cancer except luteinizing hormone-releasing hormone (LHRH) agonists or any stable dose (i.e., on current dosing for ≥ 1 month) of megestrol acetate or corticosteroids
Radiotherapy Surgery - At least 4 weeks since prior major surgery
Other - No other concurrent investigational or commercial agents or therapies for the malignancy
- No concurrent herbal or alternative therapy or food supplements (e.g., PC-SPES, saw palmetto, or Hypericum perforatum [St. John's wort])
- Concurrent daily multivitamin allowed
- Concurrent bisphosphonates allowed provided dose is stable and was started ≥ 6 weeks ago and patient demonstrates subsequent PSA progression
- No initiation of bisphosphonate therapy immediately prior to or during study therapy
Patient Characteristics:
Age Performance status Life expectancy Hematopoietic - Absolute neutrophil count ≥ 1,500/mm3
- Platelet count ≥ 100,000/mm3
Hepatic - Bilirubin normal
- AST and ALT ≤ 2.5 times upper limit of normal (ULN)
Renal - Creatinine ≤ 1.5 times ULN
Cardiovascular - No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
Other - Testosterone < 50 ng/dL
- Fertile patients must use effective contraception
- No ongoing or active infection
- No psychiatric illness or social situation that would preclude study compliance
- No other uncontrolled illness
- No other currently active malignancy within the past 2 years except nonmelanoma skin cancer or superficial bladder cancer
Expected Enrollment 32A total of 32 patients will be accrued for this study within 16 months. Outcomes Primary Outcome(s)Prostate-specific antigen (PSA) response
Secondary Outcome(s)Mean change in PSA slope Percent of PSA slope decrease after completion of study treatment Efficacy Toxicity Survival time Time to progression Duration of response
Outline This is an open-label, multicenter study. Patients receive cilengitide IV over 1 hour on days 1, 4, 8, 11, 15, 18, 22, and 25. Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. After 3 courses, patients undergo evaluation. Patients achieving a complete prostate-specific antigen (PSA) response (i.e., PSA < 0.2 ng/mL) receive 2-3 additional courses of therapy. Patients with partial PSA response or stable disease continue treatment indefinitely in the absence of disease progression or unacceptable toxicity. Patients demonstrating disease progression by CT scan, MRI, or bone scan are removed from the study.
Trial Contact Information
Trial Lead Organizations University of Michigan Comprehensive Cancer Center | | | Maha Hadi Hussain, MD, Protocol chair | | Ph: 734-936-8906; 800-865-1125 |
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Related Information Featured trial article
Registry Information | | Official Title | | Phase II Evaluation of EMD121974 (NSC 707544, Cilengitide) in Patients With Non-Metastatic Androgen-Independent Prostate Cancer | | Trial Start Date | | 2005-01-18 | | Trial Completion Date | | 2008-02-19 | | Registered in ClinicalTrials.gov | | NCT00121238 | | Date Submitted to PDQ | | 2005-06-22 | | Information Last Verified | | 2008-08-15 | | NCI Grant/Contract Number | | CA46592 |
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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