Clinical Trial Details

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Study ID NCI-2012-03066
Investigator
Maha Hussain,   University of Michigan University Hospital
Title Cilengitide in Treating Patients With Prostate Cancer
Conditions Recurrent Prostate Cancer
Stage I Prostate Cancer
Stage IIA Prostate Cancer
Stage IIB Prostate Cancer
Stage III Prostate Cancer
Interventions Drug: cilengitide
Other: laboratory biomarker analysis
Phase Phase 2
Purpose This phase II trial is studying how well cilengitide works in treating patients with prostate cancer. Cilengitide may stop the growth of prostate cancer by blocking blood flow to the tumor
Eligibility Ages Eligible: 18 Years
Genders Eligible:  Male
Accepts Healthy Volunteers:  No
Inclusion Criteria:
  • A histologic or cytologic diagnosis of prostate cancer
  • No evidence of metastatic disease, or local progression
  • PSA-only progression despite androgen deprivation therapy and antiandrogen withdrawal (28 days for flutamide and 42 days for bicalutamide or nilutamide); PSA progression is defined as 3 consecutive rising levels, with an interval of > 1 week between each determination; the last determination must have a minimum value of >= 2 ng/ml and be determined within two weeks prior to registration - If the third confirmatory value is less than the previous value, the patient will still be eligible if a repeat value (No. 4) is found to be greater than the second value
  • Patients must continue on LHRH agonists; they also may continue on any stable doses (considered stable, if on current medicine dosing for one month or longer) of megace or corticosteroids; they must be off all other therapies intended to treat the cancer for 4 weeks
  • ECOG performance status of 0-2
  • No prior EMD 121974 therapy is allowed
  • No investigational or commercial agents or therapies may be administered with the intent to treat the patient's malignancy
  • Testosterone < 50 ng/dl; patients must continue primary androgen deprivation with an LHRH agonist, if they have not undergone orchiectomy
  • Four weeks must have elapsed since major surgery
  • Life expectancy of greater than 6 months
  • Patients must have normal organ and marrow function as defined below obtained within 14 days prior to registration:
  • ANC >= 1,500/µl
  • Platelet count >= 100,000/ µl
  • Creatinine =< 1.5 x upper limits of normal
  • Bilirubin within normal limits
  • SGOT (AST) =< 2.5 x upper limits of normal
  • SGPT (ALT) =< 2.5 x upper limits of normal
  • PSA >= 2 ng/ml
  • The effects of EMD 121974 on the developing human fetus at the recommended therapeutic dose are unknown; for this reason and because antiangiogenic agents are known to be teratogenic, men must agree to use adequate contraception prior to study entry and for the duration of study participation
  • Ability to understand and the willingness to sign a written informed consent that is approved by the Institutional Human Investigation Committee
Exclusion Criteria:
  • Patients may continue on a daily Multi-Vitamin, but all other herbal, alternative and food supplements (i.e. PC-Spes, Saw Palmetto, St John Wort, etc.) must be discontinued before registration
  • Patients on stable doses of bisphosphonates which have been started no less than 6 weeks prior to protocol therapy, that show subsequent PSA progression, may continue on this medication, however patients are not allowed to initiate bisphosphonate therapy immediately prior or during the study
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Patients with a "currently active" second malignancy, other than non-melanoma skin cancers or superficial bladder cancer, are not eligible; patients are not considered to have a "currently active" malignancy if they have completed therapy and are now considered without evidence of disease for 2 years
Study Location
University of Michigan University Hospital
Ann Arbor, Michigan, 48109
Contact N/A

Information objtained from ClinicalTrials.gov, on 7/24/2014. For additional information about this and other clinical trials, visit http://clinicaltrials.gov.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00121238


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