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

• Status: Completed
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Weill Medical College of Cornell University
• Treatments: Antibodies; Docetaxel; Prednisone

Criteria

Inclusion Criteria:

• Histologic diagnosis of prostate adenocarcinoma.

• Patient must have progressive metastatic prostate cancer despite adequate medical or surgical castration therapy.

• Serum testosterone < 50 mg/ml.

• Patients who have previously received docetaxel must meet BOTH of the the following criteria:

• 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

Exclusion Criteria:

• Use of red blood cell or platelet transfusions within 4 weeks of treatment.

• Use of hematopoietic growth factors within 4 weeks of treatment.-Prior cytotoxic chemotherapy and/or radiation therapy within 4 weeks of treatment.

• Bone scan demonstrating confluent lesions involving both axial and appendicular skeleton ("superscan").

• Prior radiation therapy encompassing >25% of skeleton.Prior treatment with 89Strontium or 153Samarium containing compounds (e.g. Metastron®, Quadramet®).

• Platelet count <150,000/mm3.

• Absolute neutrophil count (ANC) <2,000/mm3.

• Hematocrit <30 percent or Hemoglobin < 10 g/dL.

• Abnormal coagulation profile (PT or INR, PTT) > 1.3 x upper limit of normal (unless on therapeutic anticoagulation).

• -Serum creatinine >2.5 mg/dL.

• AST (SGOT) >2.5x ULN.

• Bilirubin (total) >1.5x ULN.

• Serum calcium >11 mg/dL.

• Active serious infection.

• Active angina pectoris or New York Heart Association Class III-IV.

• ECOG Performance Status >2.

• Life expectancy <6 months.

• Deep vein thrombosis and/or pulmonary embolus within 1 month of study entry.

• 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.

• Prior anti-PSMA monoclonal antibody therapy with the exception of ProstaScint®.

• Prior investigational therapy within 6 weeks of treatment.

• Known history of HIV.

• Known history of myelodysplastic syndrome or leukemia