Trial Search Results

MEDI-522 in the Treatment of Patients With Metastatic Androgen-Independent Prostate Cancer

The primary objectives of this study are:

1. To explore the antitumor activity of MEDI-522 in combination with docetaxel, prednisone, and zoledronic acid in patients with metastatic Androgen-Independent Prostate Cancer (AIPC); and

2. To summarize the safety of MEDI-522 in combination with docetaxel, prednisone, and zoledronic acid in this patient population.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

MedImmune LLC

Stanford Investigator(s):

Intervention(s):

  • Biological: MEDI-522
  • Biological: Docetaxel + Prednisone* + Zoledronic Acid

Phase:

Phase 2

Eligibility


Inclusion Criteria:

   - Adult men at least 18 years of age at the time of randomization.

   - Metastatic, histologically or cytologically confirmed adenocarcinoma of the prostate
   that has progressed after start of androgen deprivation therapy, which includes prior
   orchiectomy or medical castration using leuteinizing hormone-releasing hormone (LHRH)
   antagonists such as leuprolide or goserelin (patients must remain on LHRH analogue
   therapy for the duration of the study if not surgically castrated). Progressive
   disease should be documented by:

   a. PSA progression (defined as two consecutive increases in PSA over a previous
   reference value, with the first increase in PSA occurring at a minimum of 1 week after
   the reference value [obtained within 2 months prior to study randomization] and
   confirmed by a subsequent increase in PSA whose value must be ³ 5 ng/mL prior to study
   randomization);41 and one of the following: i. Bone metastases (defined as ³3 foci on
   bone scan and confirmed radiologically within 1 month prior to study randomization);
   or ii. Measurable non-bony metastatic disease (documented by radiographic studies
   performed within 1 month prior to study randomization).

   - Serum testosterone levels <50 ng/dL documented in non-surgically castrated patients
   within 21 days prior to randomization.

   - Prior treatment with nonsteroidal antiandrogens (e.g., flutamide or bicalutamide) is
   allowed provided:

   - There is evidence of disease progression (defined in Inclusion Criteria #2) following
   withdrawal of antiandrogens; and b. At least 4 weeks for flutamide or 6 weeks for
   bicalutamide have passed since last treatment.

   - Prior treatment with ketoconazole and/or steroids is allowed provided at least 4 weeks
   have passed since last treatment. There are no restrictions for use of prednisone (5
   mg twice daily) or another functionally equivalent oral corticosteroid for treatment
   of pain.

   - In the rare instance a patient is potent, he must agree to practice an effective
   method of contraception including condom or abstinence, unless his sexual partner is
   sterile, from the time of first administration of MEDI-522 or docetaxel through 30
   days after the last dose of either docetaxel or MEDI-522, whichever is the last drug
   discontinued.

   - Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 documented
   within 21 days prior to randomization.

   - Life expectancy, in the opinion of the investigator, of at least 6 months.

   - White blood cell (WBC) count ≥ 3,000/mm3; absolute neutrophil count (ANC) ≥ 1,500/mm3;
   platelet count ≥ 100,000/mm3; and hemoglobin ³ 9 g/dL documented within 21 days prior
   to randomization.

   - Bilirubin ≤ ULN; aspartate transaminase (AST)/alanine transaminase (ALT) £1.5 times
   ULN or if AST/ALT is >1.5 times ULN, then alkaline phosphatase must be £2.5 times ULN;
   serum creatinine ≤ 1.5 mg/dL; INR within normal range, unless a patient is receiving
   anticoagulation therapy; and corrected serum calcium between 8.0-11.5 mg/dL documented
   within 21 days prior to randomization.

   - Patients who had prior major surgery are eligible if at least 4 weeks have passed
   since their surgery and all surgical wounds have healed prior to study randomization.

   - Prior radiotherapy including therapeutic isotopes is allowed provided measurable or
   evaluable disease that is clearly progressing is present and all acute
   radiation-related toxicities have resolved prior to study randomization.

   - Prior treatment with unconventional therapy for malignancy (e.g., vitamins, St. John's
   Wort, PC-SPES, saw palmetto, or other herbal remedies) is allowed provided at least 4
   weeks have passed since last treatment prior to randomization.

   - Written informed consent and HIPAA authorization (USA sites only) obtained from the
   patient prior to receipt of any study medication or beginning study procedures.

Exclusion Criteria:

   - Prior chemotherapy for metastatic prostate cancer (prior adjuvant chemotherapy is
   allowed provided it is non-taxane based and at least 6 months have passed since last
   treatment).

   - Prior treatment with other investigational agents within 4 weeks prior to
   randomization.

   - Planned concurrent treatment with unconventional therapy for malignancy (e.g.,
   vitamins, St. John's Wort, PC-SPES, saw palmetto, or other herbal other herbal
   remedies) based on medical history. Currently requiring anticoagulation (excluding use
   of heparin flush solutions for maintenance of catheter lines) for any thromboembolic
   disease based on medical history and physical examination.

   - Current or planned participation (from the time of randomization through 30 days after
   the last dose of either docetaxel or MEDI-522, whichever is the last drug
   discontinued) in a research protocol in which an investigational agent or therapy may
   be administered.

   - Any evidence of or history elicited by the investigator of prior treatment with
   MEDI-522 or MEDI-523.

   - Prior treatment with calcitonin, mithramycin, or gallium nitrate within 2 weeks prior
   to randomization.

   - Clinically evident central nervous system (CNS) metastasis.

   - History of prior malignancies within the past 5 years other than adequately treated
   basal cell or squamous cell skin cancer or Stage I or II cancer currently in complete
   remission;

   - Any evidence of or history elicited by the investigator of symptomatic cerebrovascular
   events (i.e., stroke or transient ischemic attack) within 6 months prior to
   randomization; or any history or evidence of pulmonary embolism or thrombophlebitis
   (including deep vein thrombosis) requiring anticoagulant therapy (e.g., warfarin or
   heparin).

   - Any evidence of or history elicited by the investigator of myocardial infarction or
   angina within 6 months prior to randomization.

   - Any evidence of or history elicited by the investigator of hematemesis, melena,
   hematochezia, or uncontrolled gross hematuria within 4 weeks prior to randomization.

   - Any evidence of or history elicited by the investigator of bleeding diatheses.

   - Major elective surgery planned from the time of randomization through 30 days after
   the last dose of either docetaxel or MEDI-522, whichever is the last drug
   discontinued.

   - Any evidence of or history elicited by the investigator of hypersensitivity to a
   previously administered monoclonal antibody.

   - Any evidence of or history elicited by the investigator of hypersensitivity to drugs
   formulated with polysorbate 80, prednisone (or other functionally equivalent oral
   corticosteroid), or zoledronic acid.

   - Known human immunodeficiency virus (HIV) or known active viral hepatic infections
   based on medical history and physical examination.

   - Any evidence of or history elicited by the investigator of uncontrolled or refractory
   hypertension or uncontrolled diabetes despite medication within 6 months prior to
   randomization.

   - Any evidence of or history elicited by the investigator of an active infection
   requiring parenteral anti-infective therapy.

   - A general medical or psychological condition or behavior, including substance
   dependence or abuse that, in the opinion of the investigator, might not permit the
   patient to complete the study or sign the informed consent.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

Male

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Denise Haas
6507361252
Not Recruiting