Clinical trial NCT00121238 (phase 2, status: completed)
Conditions: recurrent prostate cancer, stage i prostate cancer, stage iia prostate cancer, stage iib prostate cancer, stage iii prostate cancer
ICD codes: C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5, C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5, C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5, C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5, C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5
Drugs: cilengitide
SMILES: CN1N=NC2=C(N=CN2C1=O)C(N)=O
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