TheranosticTrials.org

Clinical Trial · NCT00916123

Docetaxel/Prednisone Plus Fractionated 177Lu- J591 Antibody for Metastatic, Castrate-resistant Prostate Cancer

Overview

The purpose of this study is to test the effectiveness of the experimental drug, 177Lu-J591 antibody in combination with docetaxel chemotherapy against metastatic, castrate-resistant prostate cancer.

Sponsor

Weill Medical College of Cornell University

Phase

Phase 1

Contacts

Scott Tagawa, M.D. (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT00916123

Eligibility

Inclusion

  • Patients who have previously received docetaxel must meet BOTH of the the following criteria:
  • Serum testosterone \< 50 mg/ml.
  • reason for docetaxel discontinuation must NOT have been progression of disease while receiving drug (i.e. progression of cancer must have been AFTER docetaxel discontinuation) AND
  • All docetaxel-related toxicities must have resolved to \< grade 1 (with the exception of alopecia) and the pt must be eligible by other criteria
  • Histologic diagnosis of prostate adenocarcinoma.
  • Patient must have progressive metastatic prostate cancer despite adequate medical or surgical castration therapy.

Exclusion

  • Prior anti-PSMA monoclonal antibody therapy with the exception of ProstaScint®.
  • Active angina pectoris or New York Heart Association Class III-IV.
  • Platelet count \<150,000/mm3.
  • Prior radiation therapy encompassing \>25% of skeleton.Prior treatment with 89Strontium or 153Samarium containing compounds (e.g. Metastron®, Quadramet®).
  • Other serious illness(es) which might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study.
  • -Serum creatinine \>2.5 mg/dL.
  • Deep vein thrombosis and/or pulmonary embolus within 1 month of study entry.
  • Bone scan demonstrating confluent lesions involving both axial and appendicular skeleton ("superscan").
  • Hematocrit \<30 percent or Hemoglobin \< 10 g/dL.
  • Absolute neutrophil count (ANC) \<2,000/mm3.
  • Life expectancy \<6 months.
  • AST (SGOT) \>2.5x ULN.
  • Prior investigational therapy within 6 weeks of treatment.
  • Use of red blood cell or platelet transfusions within 4 weeks of treatment.
  • Active serious infection.
  • Known history of HIV.
  • Serum calcium \>11 mg/dL.
  • ECOG Performance Status \>2.
  • Bilirubin (total) \>1.5x ULN.
  • Abnormal coagulation profile (PT or INR, PTT) \> 1.3 x upper limit of normal (unless on therapeutic anticoagulation).
  • Use of hematopoietic growth factors within 4 weeks of treatment.-Prior cytotoxic chemotherapy and/or radiation therapy within 4 weeks of treatment.