Cilengitide in Treating Patients With Prostate Cancer
Condition: Recurrent Prostate Cancer; Stage I Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer; Stage III Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: cilengitide
Intervention description: Given IV
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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 criteria:

        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